Process Manager

15 hours ago


Cork, Ireland NRL Full time

Job Purpose:

Provide front line expert support for all process-specific issues to production within one or more production steps, to ensure execution of processes on-time, continuously improving in quality and productivity, performed in compliance to cGMPs, SOPs and applicable guidelines and functional standards (e.g. HSE, NOSSCE).

Responsibilities:

1. Provide front line support to manufacturing, working with the shift teams, focusing on manufacturing each batch safely, on time, in compliance with the batch instructions and quality requirements.
2. Responsible for maintaining the master manufacturing documents of assigned products (e.g. Master Batch Record, Bill of Material (BOM) & Recipe, Quality Risk Assessment, Zurich Hazard Analysis).
3. Ensure that all critical parameters are within written instruction.
4. Ensure that all process changes in assigned products are managed through appropriate change control procedure.
5. Ensure creation of production SOPs and Master Batch Records.
6. Act as Subject Matter Expert (SME) for the product and process knowledge, be highly knowledgeable of product and process trends by providing input to APQR for analysis and for driving process technology innovations.
7. Collect data for ongoing process verification (OPV), support product steward in tracking and evaluation of product performance and implementation of CAPAs.
8. Perform first line evaluation of product and process related issues (deviations, complaints, OOS, OOE).
9. Support product steward for assessment of technical changes, establishment of root-cause analysis, Quality Risk Assessment, process control strategy.
10. Maintain processes at inspection readiness level.
11. Support process optimization establishment and new technology introduction for continued productivity improvement, as appropriate.
12. Review validation protocols and reports for technical correctness.
13. Support the execution of process validations, and short-term improvement projects, liaising with all the relevant parties at shop floor to ensure accurate execution.
14. Responsible for creating the master manufacturing documents of assigned products, as appropriate.
15. Be knowledgeable of process design by providing input during process transfer.
16. Ensure that technical batches generate sufficient process knowledge by thoroughly testing critical variables.
17. Support technology trainings and education programs for production operators.

Requirements

1. BSc. in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent scientific degree.
2. Minimum 3 years’ experience in process support role on the shop floor of GMP manufacturing and/or QA/QC.
3. Proven process understanding (Pharma, GMP, Regulatory aspects).

#J-18808-Ljbffr



  • Cork, Ireland RedChair Recruitment Full time

    Our client is in search of a Process Development Manager to assume a pivotal role in a critical project for their organization. The selected candidate will be responsible for optimizing the advantages of digitalization across their operations. Our client, a leading supplier of bakery ingredients in Ireland, serves craft, commercial, artisan bakers, and...


  • Cork, Ireland Life Science Recruitment Ltd Full time

    Process Microbiologist RK1162 Contract - 12 months Cork Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Reporting into the Snr Plant Microbiologist, the Process...

  • Process Scientist

    1 week ago


    Cork, Ireland Hays Specialist Recruitment Ireland Ltd Full time

    Your new company Here in Hays Recruitment, our Multinational Biopharmaceutical client in Cork is hiring a Process Scientist on an initial contract. This role will support development projects and manufacturing operations and be responsible for leading or supporting Process Development, Technical Transfer, Process Validation, Manufacturing investigations,...

  • Process Chemist

    2 hours ago


    Cork, Ireland Pfizer Ireland Full time

    Process Chemist Scientific Excellence Process Chemist Ringaskiddy API site in Cork plays a critically strategic role within Pfizer, it is the global site for new small molecule API products through scale up and launch, as well as manufacture of large volume patented and off-patent medicines. Colleagues on the site use state of the art equipment and...


  • Cork, Ireland Next Phase Recruitment Limited Full time

    We are seeking a dedicated and knowledgeable Process Safety Engineer to join our team. The successful candidate will play a key role in implementing and maintaining our Health, Safety, Environmental Management, and Sustainability programs, ensuring the safety of employees, processes, and surrounding communities. This position involves conducting risk...


  • Cork, Ireland Access Talent Group Full time

    ATG are seeking a dedicated and innovative Environmental Process Engineer to design, develop, and optimize environmentally sustainable processes and systems. The ideal candidate will integrate engineering principles with environmental best practices to minimize the environmental impact of industrial operations while ensuring regulatory compliance and...


  • Cork, Ireland Tbwa ChiatDay Inc Full time

    At Unispace, we are committed to transforming workplaces to meet the diverse needs of today’s dynamic global brands. Our agile, end-to-end approach is delivered seamlessly across borders, fueled by strong client partnerships and supported by insightful workplace intelligence and innovative technology. We believe that everyone deserves to work in an...


  • Cork, Ireland PE Global Full time

    PE Global is currently recruiting for a Process Microbiologist on behalf of our client based in Cork. Full Time 12 Month Contract Reporting into the Snr Plant Microbiologist the Operations microbiologist is responsible for Active participation in the microbiological control and assurance program within the operations department. Managing activities in...


  • Cork, Ireland Stryker Ireland Full time

    23 month Fixed Term Contract hybrid role based in Carrigtwohill, Cork, Ireland Who we want: Detail-oriented process improvers. Critical thinkers who naturally seek opportunities to create, develop and transform business processes - finding ways to simplify, standardize and automate. User-focused creators. People who imagine with the user in mind, developing...


  • Cork, Ireland Cpl Resources Full time

    Kenny-Whelan (a specialist division of the CPL group) are hiring a Technical Process Microbiologist to work on contract at Janssen Sciences in Ringaskiddy Cork NEW vacancy DEC 2024 Contact Jenn Dinan on or email Technical Process Microbiologist Location: Cork Barnahely Contract: Full Time 12 Month Contract Job Summary Reporting into the Plant Microbiologist...


  • Cork, Ireland PM Group Full time

    Overview PM Group is an employee owned, international project delivery firm with a team of 3,500+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our...


  • Cork, Ireland PM Group Full time

    Overview PM Group is an employee owned, international project delivery firm with a team of 3,600+ people. We are world leaders in the pharma, food, medtech and mission critical sectors. From our network of offices in Europe, Asia and the US, we work with the world's leading organisations. We are focused on growing a sustainable business centred around our...


  • Cork, Ireland Johnson & Johnson Full time

    Job Description - Maintenance Engineer - Aseptic Processing (2506229340W) About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal....


  • Cork, Ireland PepsiCo Deutschland GmbH Full time

    Overview PepsiCo is on the look-out for a Global Process Safety Senior Engineer to join our global engineering function based in Cork. We are the concentrate business in PepsiCo (PGCS) working across the Beverage, Nutrition and Snacks categories to deliver concentrate for many of PepsiCo’s mega brands including Gatorade, 7Up and Pepsi. We are at the...


  • Cork, Ireland PM Group Full time

    Overview We are expanding our Process capability in Cork and are looking for Senior Process Engineers to join our team (we already have over 100+ process professionals on the team). You'll get the opportunity to become involved in some of the most interesting and largest Pharma/Bio projects in the world. In addition to managing large-scale one-off...


  • Cork, Ireland Cpl Resources Full time

    Kenny-Whelan (a specialist division of the CPL group) are recruiting 2 x Manufacturing Process Specialists to work on the Material Supply Optimization Team at Janssen Sciences in Ringaskiddy Level 8+ Degree essential Not a production operator/Light Industrial role. Contact Jenn Dinan on or email your CV to ?MUST ALREADY BE ELIGIBLE TO WORK ON CONTRACT IN THE...


  • Cork, Ireland Unispace Life Sciences Full time

    Unispace Life Sciences is one of the leading engineering design and project management firms in the industry. We deliver process and utility facility as well as laboratory and workspace design and construction projects for pharmaceutical, biopharmaceutical, advanced therapeutics, medical device, and other life sciences companies. Part of Unispace Group, our...


  • Cork, Ireland Cregg Recruitment Full time

    Process Technician - Cork CREGG are currently hiring a Process Technician to work onsite with a leading multinational Medical Device client in Cork, working on the latest automated manufacturing equipment. This role offers a 3 day work week with 4 days off. Shifts - 3x12 hours per week, rotating from front end to back end every 4 weeks Sun, Mon, Tue, for 4...


  • Cork, Ireland Stryker Ireland Full time

    Permanent hybrid role based in Carrigtwohill, Cork Job Description: Are you a Process /Automation Engineer with experience in Electronics manufacturing ? Are you ready to take on the responsibilities of a Staff Process Development Engineer who will develop new ways of realising the design of electronic components to manufacturing for our ENT powered...


  • Cork, Ireland CPL Full time

    Kenny-Whelan (a specialist division of the CPL group) are recruiting 2 x Manufacturing Process Specialists to work on the Material Supply Optimization Team at Janssen Sciences in Ringaskiddy Level 8+ Degree essential Not a production operator/Light Industrial role. Contact Jenn Dinan on 0214665408 or email your CV to [email protected] MUST ALREADY BE...