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    Senior DP Engineer – Lyophilisation As the Drug Product Engineer – Lyophilisation you will ensure compliance with industry standards and oversee engineering policies and procedures. Your role involves managing various aspects of equipment installation, validation, and maintenance to ensure the safe and effective operation of the manufacturing facility and provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs. In this role you’ll be reporting to the DP Engineering Lead. Essential Duties and Responsibilities: Provide technical leadership within a new Vaccine Drug Product Manufacturing facility. Ensure all equipment installed is safe, effective and in compliance with industry standards. Ensure all company and site engineering policies and procedures are adhered to. Provide technical and compliance review and/or authorship of testing protocols, reports and applicable manufacturing SOPs. Lead Commissioning & Qualification activities for new equipment. Generate and execute documentation for cGMP activities including risk assessments and CQV protocols/reports. Management of Equipment Vendors including execution of SAT, on-site maintenance visits, management of continuous improvement projects & spare parts criticality assessments. Support/lead maintenance of the validated state of the equipment through execution of revalidation protocols as per Site VMP. Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement, and process optimization using tools such as DMAIC and FMEA. Manage changes to equipment/process as per site change control procedures. Support establishment of new Preventative Maintenance Program for equipment in Drug Product suite. Lead/participate in equipment related manufacturing investigations with cross-functional teams to ensure that detailed root cause analysis & impact analysis is completed and appropriate CAPAs are implemented. Identify process and equipment improvements and develop these into CI projects. Support disposition of batches by addressing any potential technical / engineering related issues which may have occurred mid-batch. Lead/participate in TPM, CI & Gemba programs and daily / weekly tiered manufacturing meetings. Participate in process, design & technical reviews with external clients. Provide technical expertise during regulatory inspections e.g. FDA, HPRA inspections to defend systems, change controls, investigations and qualification packages. Support transition from project to sustaining manufacturing and ramp up of production volumes in future by improving equipment reliability through CI and TPM processe Experience Required: Specific experience with Lyophiliser Freeze dryer equipment. Knowledge of Refrigeration processes. Experience in start-up facilities is advantageous. CQV experience is advantageous. Knowledge of industry/ regulatory requirements such as Annex 1 desirable. Ability to explain complex technical issues to external customers / agencies. Demonstrated excellence in planning and organizational skills. Demonstrated skills in communication (oral and written) & in particular technical writing. Minimum 5 years cGMP industrial / engineering experience, Experience in executing on the floor activities such as FAT, SAT, IQ/OQ Experience in data driven approach to root cause analysis and prioritization of continuous improvement initiatives e.g. Six Sigma Experience in leading & resolving complex technical investigations. Experience in a risk-based approach to manufacturing through use of tools such as FMEA Ability to adapt to changing priorities as project demands change

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    Ehs Manager  

    - Dundalk

    Environmental Health & Safety Manager Job Dundalk Co Louth Salary €60,000 - €75,000 Are you passionate about fostering a positive Environment, Health & Safety (EHS) culture within a manufacturing environment? Do you possess expert knowledge and skills in EHS management? If so, I have an exciting opportunity for you! The role As their EHS Manager , you will play a crucial role in championing safety initiatives and ensuring compliance with all relevant regulations and standards. You'll be at the forefront of developing, implementing, and maintaining systems to identify and mitigate hazards, conduct thorough accident investigations, and lead EH&S improvement programs. Key Responsibilities: Safety Champion: Develop, implement, and maintain hazard identification and risk assessment systems, while coordinating the closure of health and safety root causes. Lead accident/incident investigations and ensure statutory inspections and audits are conducted and documented. Functional Safety Lead: Act as the Functional Safety Lead across Value Streams, collaborating closely with Value Stream Managers and safety representatives to uphold safety standards, including 6S practices. Regulatory Liaison: Serve as the lead site representative in communication and coordination with local health and safety authorities, ensuring compliance with governmental regulations. Delivery Excellence: Facilitate and lead technical improvements in collaboration with project, maintenance, and engineering departments to enhance safety and productivity. People Development: Promote a collaborative safety culture by delivering comprehensive H&S training programs and ensuring adherence to statutory requirements. What We Offer: An opportunity to make a significant impact by shaping a positive EHS culture. A supportive environment where your expertise and leadership will be valued. Competitive compensation package with benefits including salary to €75,000 based on experience, Bonus, Pension, 22 days holiday including stats Continuous learning and development opportunities. How to apply If you're ready to take on a challenging yet rewarding role as an EHS Manager and contribute to the success of their organisation, I want to hear from you! Apply now and be part of their journey towards excellence in environment, health, and safety. Please Note: We have checked with our client and they will not support an application for visa sponsorship and all applicants for this role must have an unrestricted right to work in Ireland

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    QA Validation Engineer  

    - Dundalk

    QA Validation Process Engineer QA Validation Engineer Based within the QA department the QA Validation Engineer will be responsible for providing the company with technical and quality resources to manage the quality deliverables on projects, coordinate the necessary activities for ensuring the timely closure of internal/external quality issues and ensuring an effective quality system. Department Description As QA Validation Engineer you’ll be joining an organization where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QA Validation Lead. Your Responsibilities * Quality review and approval of qualification/validation documentation and associated data for conformance to regulations, Standard Operating Procedures (SOPs), specifications and other applicable acceptance criteria. * Work in conjunction with Engineering Departments to co-develop design verification & validation protocols for new products and for changes on existing products, review and approve protocols/studies, and perform general oversight responsibilities for the validation process (both equipment and processes). * Ensure all equipment and processes are safe, effective and qualified in compliance with industry standards and regulatory expectations. * Active member of the QA review board to provide overall quality direction and oversight for key functional areas (i.e. PEV, QC, Supply Chain, Engineering, CSV), ensuring that programs, policies and procedures are robust and in keeping with regulatory and client expectations * Act as a Quality point of contact and support decision making during New Product Introductions, Technology Transfer and Process Validation activities whilst ensuring that all activities meet client and regulatory expectations. * Support a safe working environment by complying with all pertinent environmental health/safety practice, rules and regulations * Perform all activities in compliance with client safety standards and SOPs * Assist in implementation of global standards and procedures into the site Quality Systems. * Provide regular reporting for KPIs, metrics, dashboards and other efforts * Participate in other projects/duites as assigned. Your Profile: The ideal candidate for this position, will have the following: Education * Bachelor’s degree in an Engineering or Scientific related discipline. Knowledge/Experience Required: * Robust experience in a Quality Engineering/Quality Assurance role for Biologics, medical device or pharmaceutical manufacturing. * Knowledge of Statistical Process Control and Six Sigma methodologies (Greenbelt Certification would be advantageous); * Demonstrated knowledge of GxP regulations (e.g. EU-GMP, FDA, ISO) * Understanding of principles of Validation and New Product Introduction and be familiar with Computerised System Validation, Method Validation, Shipping Validation, Cleaning Validation and Process Validation. * Experience in change control, non-conformance, corrective and preventative actions, and validation practices Personal skills Preferred: * Ability to operate across functional boundaries, both internal and external * Independent, self-motivated, organized, able to multi-task in project environments and skilled in communication and collaboration. Berkley Life Science & Engineering is a specialist consultancy recruiting Life Science & Engineering professionals for organisations throughout Ireland. If you would like to discuss this vacancy further or to discuss your career options in confidence, please contact David O’Connell on + (phone number removed)


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