Process Engineer role at Thermo Fisher Scientific in Cork, Ireland, requires expertise in pharmaceutical unit operations, GMP requirements, and project management. Thermo Fisher Scientific is a global leader in the field, dedicated to enabling customers to make the world healthier, cleaner, and safer. As a Process Engineer, you will provide technical support to the manufacturing process, lead and support plant activities, and generate documentation for process start-up activities. Key responsibilities include: Providing technical support to the manufacturing process, ensuring customer requirements and site metrics are achieved. Leading and supporting plant activities and technical investigations. Generating documentation for process start-up activities. Using existing technologies and global information systems to analyze and improve product throughput and performance. Leading projects aimed at improving process engineering efficiency and implementing engineering change controls. Supporting product changeovers and completing relevant cleaning risk assessments. Delivering technical excellence in scale-up and manufacture. Supporting screening and quotation processes for the Cork site. Collaborating with diverse teams and providing guidance to new members in the process engineering team. Requirements: Honours degree or equivalent experience in Chemical/Processing Engineering. Experience in the pharmaceutical industry or equivalent. Domain authority in pharmaceutical unit operations. Excellent working knowledge of pharma plant and equipment. Strong track record in safety, environmental, and GMP excellence. Sound technical knowledge and understanding of c GMP requirements. Excellent communication, facilitation, and problem-solving skills. Project management experience. Thermo Fisher Scientific is an equal opportunity employer and is committed to creating an inclusive and diverse environment.
Technical Lead Scientist responsible for regulatory and scientific conduct of development and stability projects in a laboratory setting, with a focus on Oligonucleotides. PPD Laboratory Services team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic guides. Job Description The Associate Research Scientist will work independently to perform analytical testing, method optimization/validation, and/or other specialist technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Independently performs analytical testing, method optimization/validation, and/or other specialist technologies studies OR method transfers for pharmaceutical and biopharmaceutical compounds in a variety of formulations and/or delivery systems. Understands and conforms to methods, and protocols applicable to assigned tasks. Designs and completes experiments independently. Reviews and critiques study protocols, project status reports, final study reports and other project-related technical documents. Communicates data and technical issues to clients on a weekly basis (or as needed). Provides technical mentorship and training to staff. Leads analytical (procedural and instrumental) troubleshooting sessions. Plan, direct and implement improvements in systems and processes. Assists in preparation and implementation of SOPs and quality systems. Reviews, interprets, and analyses data for technical, quality and compliance to protocols, methods, SOPs, client criteria and Good Manufacturing Practices (GMP). Requirements Min. Degree or equivalent in Chemistry or similar. 5+ years experience that provides the knowledge and skills to perform the job. Significant industry experience within an analytical testing laboratory and GMP environment is essential. Key Skills Extensive technical expertise in HPLC/Chromatography essential. Analysis of Oligonucleotides a distinct advantage. Proven experience in troubleshooting methods. Mentorship experience. Client interaction experience is a distinct advantage. Proven experience of method development and validation. Ability to project management and deal with client audits. Ideally experience in leading CMC studies including method validation. Ability to independently perform root cause analysis for method investigations. Proven ability in technical writing skills. Time management and project management skills. Good written and oral communication skills. Ability to work in a collaborative work environment with a team. Ability to train junior staff. About PPD PPD is a leading global contract research organization (CRO) providing a comprehensive range of solutions to support the discovery and development of new medicines. Our mission is to enable our customers to make the world healthier, cleaner and safer.
Facilities Engineer responsible for ensuring the smooth operation of GMP labs, managing maintenance schedules, and coordinating with vendors to meet regulatory requirements. At PPD, part of Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Our GMP labs in Athlone are continually growing and developing, and with that, the work is dynamic – projects could include deployment of lab space, repurposing of lab space, working with vendors, to general soft facilities. Key Responsibilities:Work closely with the Facilities Manager on any facilities projects within the GMP labs. Plan and schedule all maintenance and preventative maintenance activities, generates work orders, tracks and progresses work to completion. Support the site needs, responding to communication from other departments in a timely manner. Responding to real-time requests to provide technical and mechanical assistance. Organize and implement daily work schedules, prioritize and dispatch personnel to critical tasks. Schedule work around operations to minimize impact to schedules, attend meetings with other departments to plan and schedule work. Responsible for contractors on PMs and site change projects. Perform daily walk-throughs reviewing PMs & WO's to verify that tasks are being performed to the required expectations. Keep records in an audit-ready state. Ensure all required GMP and technical documentation is generated and assure compliance with GMP guidelines and written procedures. Manage and review service contracts. Generate quotations and provide competitive prices. Assist with development of business objectives, plans and budgets. Requirements:Relevant educational qualification ideally to 3rd level. Minimum 3 years experience working in a Facilities/Maintenance role where you have responsibility for site maintenance, equipment maintenance (HVACs, boilers, etc), working with vendors, facilities and all related paperwork. Knowledge, Skills, Abilities:Decision-making role. Good understanding of Lab operations and support needed within a GMP environment. Experience with utilities such as HVACs, boilers, fume hoods, etc. Experience with soft facilities. Strong understanding of GMP. Ability to adhere to laboratory policies and standard operating procedures. Proficient computer skills. Effective communication skills. Ability to work with diverse workforce with multifaceted requirements. Ability to prioritize and coordinate resources to meet our customers' needs. Ability to work in a team environment without close supervision. Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
Graduate Analyst, Pharma role available in Athlone with immediate start dates, requiring a Life Sciences/Pharmaceutical graduate with practical lab experience. We're seeking a detail-oriented and organized individual with strong communication skills to perform routine sample preparation and analysis on small molecules/pharma related products. Key Responsibilities: Perform routine sample preparation and analysis Maintain a laboratory notebook and complete all laboratory documentation Review, interpret, and analyze data Train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines Requirements: Bachelor's Degree in Science (Chemistry, Pharma Science, or similar) Relevant work placement experience ideal Essential Skills: Self-motivated and organized Excellent communication skills Strong attention to detail Practical lab skills from education or experience (analytical chemistry, HPLC, GC, pH, UV, wet chemistry, or other laboratory techniques) At Thermo Fisher Scientific, we enable our customers to make the world healthier, cleaner, and safer. Our team of 100,000+ colleagues share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need.
Perform routine to complex sample preparation and analysis procedures to measure pharmaceutical and biopharmaceutical compounds in various formulations and biological matrices. Our team of scientists, industry thought-leaders, and therapeutic guides has a direct impact on improving patient health through expertise and innovation. As a Scientist I, you will be responsible for reviewing and compiling results, making initial determinations on acceptability, and problem-solving with assistance. You will also train on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines. Our team is committed to accuracy and quality, and we work together to accelerate research, solve complex scientific challenges, and drive technological innovation. We are a team of 100,000+ colleagues who share a common set of values - Integrity, Intensity, Innovation, and Involvement. Key Responsibilities: Perform routine to complex sample preparation and analysis procedures. Review and compile results, making initial determinations on acceptability. Problem-solve with assistance pertaining to extraction and/or instrumentation problems. Train on routine operation, maintenance, and theory of analytical instrumentation. Handle QC/QA responsibilities without supervisor or QA input. Requirements: B.S./B.A. in Chemistry or related field with 1 year of experience in an analytical testing laboratory. Associates degree in laboratory science. Knowledge of applicable regulatory authority, compendium, and ICH guidelines. Ability to understand and independently apply GMPs and/or GLPs to everyday work. Ability to utilise Microsoft Excel and Word to perform tasks. Good written and oral communication skills. Time management and project management skills. Proven problem-solving and troubleshooting abilities.
Process Engineer sought to provide technical support to manufacturing process, ensuring customer requirements and site metrics are achieved. Thermo Fisher Scientific Inc. is a global leader in the field, dedicated to enabling customers to make the world healthier, cleaner, and safer. We value inclusion, collaboration, and innovation, and we are looking for an exceptional individual with a drive to contribute to our world-class organization. Responsibilities: Provide technical support to the manufacturing process, ensuring customer requirements and site metrics are achieved. Lead and support plant activities and technical investigations. Generate documentation for process start-up activities. Analyze and improve product throughput and performance using existing technologies and global information systems. Lead projects aimed at improving process engineering efficiency and implementing engineering change controls. Support product changeovers and complete relevant cleaning risk assessments. Deliver technical excellence in scale-up and manufacture. Support screening and quotation processes. Collaborate with diverse teams and provide guidance to new members in the process engineering team. Requirements: Honours degree or equivalent experience in Chemical/Processing Engineering. Experience in the pharmaceutical industry or equivalent. Domain authority in pharmaceutical unit operations. Excellent working knowledge of pharma plant and equipment. Strong track record in safety, environmental, and GMP excellence. Solid technical knowledge and understanding of cGMP requirements. Excellent communication, facilitation, and problem-solving skills. Project management experience. As a Process Engineer, you will be part of a team that is accelerating research, solving complex scientific challenges, and supporting patients in need. Accessibility: Thermo Fisher Scientific offers accessibility services for job seekers with disabilities. We are committed to creating an inclusive and diverse environment.
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Thermo Fisher Scientific Inc. is seeking a Process Engineer with a strong focus on work behaviors and ambition to join our Manufacturing Sciences team in Cork. As a global leader in the field, we are dedicated to enabling our customers to make the world healthier, cleaner, and safer. At Thermo Fisher Scientific, we value inclusion, collaboration, and innovation, and we are looking for an exceptional individual with a drive to contribute to our world-class organization. Responsibilities: Provide technical support to the manufacturing process, ensuring customer requirements and site metrics are achieved. Lead and support plant activities and technical investigations. Generate documentation for process start-up activities. Use existing technologies and global information systems to analyze and improve product throughput and performance. Lead projects aimed at improving process engineering efficiency and implementing engineering change controls. Support product changeovers and complete relevant cleaning risk assessments. Deliver technical excellence in scale-up and manufacture. Support screening and quotation processes for the Cork site. Collaborate with diverse teams and provide guidance to new members in the process engineering team. Requirements: Honours degree or equivalent experience in Chemical/Processing Engineering. Experience in the pharmaceutical industry or equivalent. Domain authority in pharmaceutical unit operations. Excellent working knowledge of pharma plant and equipment. Strong track record in safety, environmental, and GMP excellence. Sound technical knowledge and understanding of cGMP requirements. Excellent communication, facilitation, and problem-solving skills. Project management experience. Join Thermo Fisher Scientific today and be part of a team that is accelerating research, solving complex scientific challenges, and supporting patients in need. Apply now at http://jobs.thermofisher.com. Thermo Fisher Scientific is an equal opportunity employer and is committed to creating an inclusive and diverse environment. We welcome applicants from all backgrounds and perspectives. Accessibility/Disability Access Thermo Fisher Scientific offers accessibility services for job seekers with disabilities. If you require accommodations in the job application process, please contact us at 1-855-471-2255*. Our team is here to support you. This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance. Messages for other purposes will not receive a response. #J-18808-Ljbffr
Work Schedule Standard (Mon-Fri) Environmental Conditions Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description When you are part of Thermo Fisher Scientific, you’ll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $40 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world. This role is based at our Cork, Ireland API site. Operating for over 40 years, the Cork site is proud to manufacture and supply Active Pharmaceutical Ingredients (API) to our customers for use in clinical trials and approved medicines for commercial supply - medicines to treat Cancer, Parkinson’s Disease, Depression, HIV, Congestive Heart Failure, Diabetes and Respiratory diseases, along with raw material for consumer healthcare products! Discover Impactful Work: The Senior Development Chemist will function as a key member of the Process Development service Team. This position will provide chemistry expertise and technical support for the chemical development of processes in the laboratory, kilo laboratory, pilot plant and manufacturing plants at the Cork site to ensure project timelines are meet and that the site’s technical, quality and safety metrics are all achieved. This technical position will also drive continuous improvement activities. A day in the Life: Provide technical & laboratory support for the introduction of new products to the right from route development, through scale up and implementation on plant scale Support development projects in the lab, including route scouting, route development, proof of concept and process robustness studies Propose modifications to the synthetic route to solve sophisticated chemistry issues for both laboratory and plant processes Undertake the synthesis of compounds to required quality standards, including acquiring and interpretation of analytical data Develop/Expand scientific, technical, and drug discovery knowledge by reading the peer reviewed scientific literature, attending scientific conferences and via relevant training Author or contribute to regulatory submissions, patents and other internal documentation relevant to the role Communicate with the clients and other teams to ensure the transfer of the project from the plant to the lab Work with due care and attention, perform all quality, regulatory and safety duties in a compliant manner whilst acting always in accordance with the Dignity at Work Policy, Code of Conduct Keys to Success: Education Degree, Masters or PhD in chemistry with a significant Organic Chemistry component. Experience Experience in synthetic / organic chemistry (industry or research institution preferred but not essential) Experience in leading a development project Knowledge, Skills, Abilities Proficient knowledge in synthetic organic chemistry, particularly in route development and optimization Proven ability to think critically and innovatively combined with willingness to challenge Strong analytical capability and ability to carry out large scale reactions in the laboratory Demonstrated ability in troubleshooting and solving complex issues Embrace and participate in PPI (Practical Process Improvement) initiatives to identify improvements and cost saving to the business Experience in supporting plant processes Excellent technical writing skills and verbal communication are required to interact with all level of organization and clients Ability to work with cross functional teams and engage with employees and customers at all levels What’s in it for you? Competitive base salary Annual bonus Contributory Pension Private medical insurance Free onsite parking Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued. #J-18808-Ljbffr
Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description At Thermo Fisher Scientific team, you’ll discover impactful work, innovative thinking and a culture dedicated to working the right way, for the right reasons - with the customer always top of mind. The work we do matters, like helping customers find cures for cancer, protecting the environment, making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science, with the largest investment in R&D in the industry, our colleagues are empowered to realize their full potential as part of a fast-growing, global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us. Discover Impactful Work: Are you ready to take on a pivotal role in an organization that leads the industry in scientific innovation? Thermo Fisher Scientific is seeking a Senior Director, Quality to drive our microbiological and contamination control practices across the Pharma Services Group (PSG) manufacturing network. This is an outstanding opportunity to craft the future of microbiological quality in a dynamic and high-reaching environment. This position is remote and open to candidates in Ireland, requiring regular international travel (up to 40% of working time) to visit our PSG site network worldwide, including overnight stays. What will you do? Develop and implement global microbiological procedures and practices. Monitor industry trends and ensure compliance. Act as the global SME for industrial microbiology and sterility assurance. Establish trending programs for environmental monitoring. Identify and assess changing regulatory requirements. Build and guide a robust community of practice. Implement a mentorship, coaching, and training program. Introduce a program of regular audits. Represent Thermo Fisher’s interests in industry bodies. Collaborate with PSG business leadership and site leaders. Who we are looking for: Education : Minimum BSc in Microbiology or equivalent experience, with a preference for advanced degrees. Experience: At least 15 years in a senior QA role, with direct experience in sterile or biologic dosage forms manufacturing sites. Skills & Abilities: Fluent in English (written and spoken) Willing and able to travel internationally up to 40% of working time, including overnight stays Proven ability to develop and implement global procedures. Outstanding communication and collaboration skills. Expertise in regulatory requirements and industry trends. Ability to mentor and coach talent. Capability to successfully implement quality assurance programs. What’s in it for you: We offer competitive remuneration, an annual incentive plan bonus scheme and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation. #J-18808-Ljbffr
At PPD, part of Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. Lead Facilities Coordinator Discover Impactful Work: In this role, you will join our Facilities team providing support to our local site. As a Facilities Engineer/Lead Facilities Coordinator you will ensure the team is providing the best service for our building, ensuring routine schedules and/or new qualifications are completed, remedial maintenance support, site changes/expansions, performs and documents work in accordance with standard operating procedures and established maintenance schedules to meet regulatory requirements. A Day in the Life: Work closely with the Facilities Manager on any facilities projects within the GMP labs. Takes ownership to plan and schedule all maintenance and preventative maintenance activities, generates work orders, tracks and progresses work to completion, updating job details on the in-house system and progress to close stage. Supporting the site needs, responding to communication from other departments in a timely manner. Responding to real-time requests to provide technical and mechanical assistance. Organizes and implements daily work schedules, prioritizes and dispatches personnel to critical tasks. Schedules work around operations to minimize impact to schedules, attends meeting with other departments to plan and schedule work. Responsible for contractors on PMs and site change projects. Performs daily walkthroughs reviewing PMs & WO's to verify that tasks are being performed to the required expectations. Keeping records in an audit-ready state. Ensuring all required GMP and technical documentation is generated and assuring compliance with GMP guidelines and written procedures. Manage and review service contracts. Generating quotations and providing competitive prices. Assisting with the development of business objectives, plans, and budgets. Education and Experience: Relevant educational qualification ideally to 3rd level. Min. 3 years experience working in a Facilities/Maintenance role where you have responsibility for site maintenance, equipment maintenance (HVACs, boilers, etc), working with vendors, facilities, and all related paperwork. Knowledge, Skills, Abilities: Decision-making role. Good understanding of Lab operations and support needed within a GMP environment. Experience with utilities such as HVACs, boilers, fume hoods, etc. Experience with soft facilities. Strong understanding of GMP. Ability to adhere to laboratory policies and standard operating procedures. Proficient computer skills. Effective communication skills. Ability to work with a diverse workforce with multifaceted requirements. Ability to prioritize and coordinate resources to meet our customers' needs. Ability to work in a team environment without close supervision. Our Mission is to enable our customers to make the world healthier, cleaner, and safer. Watch as our colleagues explain. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds, and perspectives are valued. #J-18808-Ljbffr
