PE Global is recruiting a Tech Transfer Lead for a leading biotech company in South Dublin. This initial 12-month contract role requires strong experience in process development support for new product introductions, as well as technical support for drug product manufacturing. The ideal candidate will have a relevant degree, excellent problem-solving abilities, and a strong understanding of cGMPs and other regulatory requirements. The role may require participation in 24/7 support on occasions, ensuring adherence to quality and safety standards. #J-18808-Ljbffr
PE Global is searching for a full-time Construction and Development Engineer in Cork. The successful candidate will play a key role in overseeing development projects from planning through to handover, ensuring compliance with regulations and managing multidisciplinary teams. A qualification in Engineering with 8–12 years of relevant experience is required. This position offers an opportunity to work closely with architects, engineers, and contractors to ensure high standards of safety and quality in project delivery. #J-18808-Ljbffr
PE Global is currently recruiting for a Tech Transfer Lead on behalf of a leading biotech company based in Dublin South. This is an initial 12-month contract role. The successful candidate will need to be prepared to participate in 24/7 support once or twice a quarter (depending on business needs) for approximately 1-2 weeks at a time. Confirmed shift pattern: It’s 2 days on 7am-7pm, 2 nights on 7pm-7am, 4 days off. Overview This role requires the candidate to provide process development support primarily to new product introductions (NPI) and lifecycle management (LCM) changes. In addition, the candidate will be expected to provide technical support to biologics drug product manufacturing as part of the global Process Development organization, with the intention of moving to a new building that will house single-use end-to-end processes and new syringe fillers. Responsibilities Supports new product introductions to PM2 and PM3 from a Process Development perspective and then serves as the Process Development SME for these products following completion of the transfer to PM2 or PM3. Be accountable for the success of the product transfer project from initiation to the transfer, through line characterisation, engineering studies, process performance qualification and ultimately to regulatory approval. Provide solutions when troubleshooting drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection and transportation for parenteral products through the NPI or post‑NPI phases. Provide process development knowledge for commercial drug product processing in specific areas such as sterile processing, process characterization, tech transfer and validation. Support commercial drug product manufacturing operations with technical evaluation of Change Control/NC/CAPA and technology transfer. Develop characterisation studies, engineering runs, electronic batch record creation, validation plans, process performance qualifications for syringe filling. Ensure all aspects of activity within any given process validation adhere to required policies and procedures, including safety and training. Ensure that the site meets the quality requirements of its customers and applicable regulations (FDA, EU & international standards) with a full understanding of CMC business process related to technology transfer. Participate in process validation cross‑functional teams at the site to ensure adherence to required policies and procedures and deliver against organizational goals and project milestones. Pre‑approve and post‑approve process validation protocols and assessments from a quality system documentation perspective. Communicate actively across functions and sites and act as a strong collaborator with all the functional groups at the receiving site, sending site and corporate functions. Act as the responsible point of contact from the site for the transfer project for drug product teams and Global Operations Teams. Assist in developing any existing validation program to ensure continued compliance with the necessary regulations and input to site validation guidance documents. Collate and report on relevant shipping and filter validation. Assist in deviation and exception resolution and root cause analysis. Contribute to product quality assessments and process flow documents. Education and Experience Third level Bachelor’s degree in science, engineering or a relevant quality discipline with 5 years of experience in a similar role OR Master’s degree and 3 years of directly related experience. Knowledge of cGMPs and other worldwide regulatory requirements. Problem‑solving ability and excellent oral and written communication skills. Experience supporting commercial protein drug product processing in specific areas such as sterile processing, process characterization, tech transfer to commercial DP sites or validation. Strong skills in applying fundamental engineering and scientific principles to design, implementation and process validation of protein freeze‑thawing, filtration, mixing, filling (PpK / batch homogeneity), and/or lyophilisation processes. Knowledge of protein biochemistry with regard to chemical and physical stability. Project management skills including the ability to manage multiple projects and evaluate project resource requirements. Strong knowledge of Quality systems, Drug Product Manufacturing and Validation. #J-18808-Ljbffr
PE Global is looking for a Talent Acquisition Specialist based in Carrigtwohill, Cork. This position is an initial 23-month contract that offers hybrid working options. The successful candidate will manage recruitment for a specific team, attract top talent, and ensure compliance with employment laws. Candidates should have at least a Bachelor's degree and 5+ years of relevant experience, preferably in the healthcare or pharmaceutical industry. Interested candidates should submit their CV to aisling.oleary@peglobal.net. #J-18808-Ljbffr
PE Global are recruiting for a Talent Acquisition Specialist for our client based in Carrigtwohill, Cork. This is an initial 23-month contract role. Hybrid working options. Job Responsibilities Recruitment will be focused on a specific team/function, or other areas as assigned. Responsible for attracting top talent and developing a strong, qualified candidate pool for current and future openings Additional job duties include pre-screening candidates, project management, partnering with team members to develop sourcing strategies and providing talent for open positions. Demonstrate ability to proactively identify, source and manage talent pools aligned to business priorities. Core responsibility is to manage open job requisitions, update and manage SmartRecruiters, achieve recruiting metrics and report key accomplishments. Will also compile and communicate the knowledge base, industry overviews, and market trends, data and analytics to team members and business leaders. Will prepare and approve offer packages, providing equity & market competitiveness data research. Ensure compliance to state/federal employment laws and policies and practices for applicant tracking compliance and reporting metrics. Establish a true business partnership with hiring managers and leadership on all staffing related activities and issues. Education & Experience Bachelor's degree required. 5+ years in-house experience in a competitive, fast pace environment required. Must project a strong business presence and have the ability to instil confidence in clients and to deliver results. Proactive recruiting and sourcing experience required. Healthcare/Pharmaceutical industry recruitment experience strongly preferred. Experience in managing requisitions within SmartRecruiters preferred. Interested candidates should submit an updated CV. Please click the link below to apply, alternatively send an up-to-date CV aisling.oleary@peglobal.net ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland**** #J-18808-Ljbffr
PE Global is seeking a MES Engineer for a 12-month onsite contract in County Sligo. You will maintain the MES environment, author and manage recipes, and provide technical guidance to the team. Ideal candidates will have over 5 years of experience in authoring with MES applications, a strong knowledge of cGMP regulations, and experience in FDA/HPRA regulated environments. Interested candidates should submit their CV to paul.wheatley@peglobal.net. #J-18808-Ljbffr
PE Global is recruiting for a MES Engineer on behalf of our biopharmaceutical client in County Sligo. This is an initial 12-month contract, fully onsite role. Job Summary Maintain the MES environment; to author and maintain recipes and worksheets for the site. Provide technical guidance and solutioning to other MES Engineers. Act as site escalation point for complex or challenging troubleshooting or recipe design. Provide project management guidance and expertise to the MES function. Responsibilities Design, create, write and/or make all required changes to MES Recipes, worksheets, equipment and material spec's including phase transition logic Design, create, write and execute, test and validation protocols, risk assessments, and system documentation. Design, create, write and/or make all required changes to ensure cleaning, equipment and product procedures are aligned to MES processes and vice versa. Design, create, write and provide training for all other site personnel on their related MES roles and arrange system access. Participate in MES knowledge exchanges, MES Governance meetings, and manage issues, work-arounds and fixes identified. Liaise with Global MES on required system improvements. Provide support to other MES system users as required to ensure business continuity. Participate in NPI projects from initiation to ensure MES system or hardware requirements are taken into consideration. Keep other recipe authors up to date on MES changes Documentation of all activities in line with cGMP requirements. Cross training within the team and training of new team members. Participation in continuous improvement programs to implement improvements in the quality, safety, environmental and production systems. Adheres to and supports all EHS standards, procedures and policies. Requirements Third Level qualification in suitable manufacturing, engineering or business course and/or suitable experience. A minimum of 5-year’s authoring experience and has led or was technical lead on multiple implementation projects. Be proficient with MES application and configuration rules and requirements including interfacing. Experience of batch processing operations in an FDA/HPRA regulated industry. Strong knowledge of cGMP and regulatory requirements relating to the pharmaceutical industry. A good knowledge of IT systems is required for this role. SAP knowledge/experience in MM, PP and IM modules. Proven attention to detail and mental concentration, to always ensure total compliance with procedures. Interested candidates should submit an updated CV. Please click the link below to apply, call Paul Wheatley on 083 094 0199 or alternatively send an up-to-date CV to paul.wheatley@peglobal.net ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** #J-18808-Ljbffr
General Operatives to carry out PCB Board Assembly on production required for Mallow based roles. These roles will have start dates in late May / early June. These roles will operate on a set shift roster for the year, and will be on a 12 month fixed term contract basis. We are primarily seeking candidates who have previous relevant production / manufacturing / assembly experience. Full training will be provided for those coming from other industries. Roles are based in County Cork, unfortunately due to working times and location own transport (CAR) is essential to get to/from site. Candidates will be assembling PCBs (Printed Circuit Boards), operating production machines and working on production line. Complete inspection and repair product if necessary Workstation and machine set up if required and safe operation of same Completion of all related documentation General housekeeping and maintaining a safe / clean work area. Ensuring that performance targets are consistently achieved, including output, quality and safety. Candidates must adhere to all job procedures / methods as directed. Candidates will have previous exposure to working in a detail orientated role in manufacturing/ industrial setting. Candidates will need to be exceptionally good in regards to working as part of a team and working to targets. Candidates will ideally be highly motivated with the ability to work on own initiative and as part of a team. Candidates must be willing to work a rotating shift roster - 3x12hr shift per week, rotating between days and nights (8.00am to 8.00pm and 8.00pm to 8.00am). Hourly Rate €20.17 per hour on shift Overtime available For more information or immediate consideration please email up to date CV, showing relevant experience to Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: 'production' 'machine operating' 'labelling' 'packaging' Benefits: Paid Holidays Parking Negotiable Compressed hours See Description TLNT1_IJ
General Operators -wanted with stores and/or forklift experience. Role may suit students etc these roles will be for either rotating Day/Night shift and/or Days only shifts. Good level of IT skills essential for these roles. *These roles are 13 to 16 week contract only, for seasonal food ingredient producer. Roles will have May start dates, candidates must be over 18 etc. Candidates ideally will have previous experience in a production environment, operating production machines or working on a production line. We are primarily seeking experienced or licenced Forklift Operators to work in busy stores dept. Previous exposure to GMP/SOP standards is ideal. Candidates with previous work experience in a food or ingredient production facility or in a highly regulated environment would have a strong advantage.Candidates must be capable of working on their own initiative. Candidates must excel at working as part of a team. Candidates will be required to have strong attention to detail specifically for record-keeping and for actively monitoring the process and responding proactively to any issues that arise. Machine faults and warning lights etc. You must be capable of carrying out manual handling activities of lifting, rotations & lowering of objects and standing for periods of time. You will be required to have the ability to work in a highly regulated environment being able to liaise effectively with colleagues and shift managers alike. 1, Warehouse Roles Forklift Experience ideally 7 Day Shift Roster: Saturday - Friday , Off 4 days Sat- Tuesday back on Wed-Tues etc 2 shift rosters - 6am - 3pm and 3pm-12pm (No actual nights) or 2, Production (Running Dryer or Evaporator Machines) 4 on 4 off , 4 days on 4 days off and then 4 nights etc 12hr shifts 7:30am-7:30pm , 7:30pm-7:30am or 3, Lactose (Previous Production or Food Processing experience essential) 12hr Shifts 4 on 4 off 7:30am - 7:30pm ( Days Only ) If the above sounds like a role that you want to hear more about or be considered for please email a fully up to date CV to Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: 'production' 'machine operating' 'labelling' 'packaging' 'forklift' 'warehouse' Benefits: Flexitime Paid Holidays Canteen Parking Negotiable Compressed hours See Description TPBN1_IJ
General Operatives to carry out PCB Board Assembly on production required for Mallow based roles. These roles will have start dates in late May / early June. These roles will operate on a set shift roster for the year, and will be on a 12 month fixed term contract basis. We are primarily seeking candidates who have previous relevant production / manufacturing / assembly experience. Full training will be provided for those coming from other industries. Roles are based in County Cork, unfortunately due to working times and location own transport (CAR) is essential to get to/from site. Candidates will be assembling PCBs (Printed Circuit Boards), operating production machines and working on production line. Complete inspection and repair product if necessary Workstation and machine set up if required and safe operation of same Completion of all related documentation General housekeeping and maintaining a safe / clean work area. Ensuring that performance targets are consistently achieved, including output, quality and safety. Candidates must adhere to all job procedures / methods as directed. Candidates will have previous exposure to working in a detail orientated role in manufacturing/ industrial setting. Candidates will need to be exceptionally good in regards to working as part of a team and working to targets. Candidates will ideally be highly motivated with the ability to work on own initiative and as part of a team. Candidates must be willing to work a rotating shift roster - 3x12hr shift per week, rotating between days and nights (8.00am to 8.00pm and 8.00pm to 8.00am). Hourly Rate €20.17 per hour on shift Overtime available For more information or immediate consideration please email up to date CV, showing relevant experience to Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: 'production' 'machine operating' 'labelling' 'packaging' Benefits: Paid Holidays Parking Negotiable Compressed hours See Description TPBN1_IJ
