
Commissioning & Qualification Specialist - Sterile Manufacturing
3 days ago
We are seeking a highly skilled Senior Commissioning & Qualification (C&Q) professional to lead the development and implementation of C&Q strategies for component preparation systems. The ideal candidate will have extensive experience in designing, planning, and executing C&Q activities for pharmaceutical/biotech sector facilities.
Key Responsibilities:- Develop comprehensive C&Q plans and schedules for component prep equipment and black utility systems
- Collaborate with cross-functional teams to prepare and execute C&Q documentation, including commissioning protocols, IQ/OQ, and FAT documentation
- Support and attend vendor site visits in Europe
- Drive the completion of C&Q documentation through to closure in a timely, quality-focused manner
- Ensure testing is conducted in compliance with GMP, FDA, and EU regulations
- Lead risk assessments, deviation resolution, and ensure robust documentation practices
- Autoclaves
- Parts Washers
- Single-Use Mixers & TCUs
- Utility Panels & Filtration Systems (e.g. TFF)
- Powder Handling Equipment (e.g. Jet Mills, Blenders)
- Black Utilities (Chilled Water, Compressed Air, Drainage, etc.)
- Minimum Bachelor's degree in Engineering, Science, or related technical discipline
- 7+ years of C&Q experience in the pharmaceutical/biotech sector, ideally in sterile manufacturing environments
- Proven expertise with component preparation systems and utility-based equipment
- Experience in document generation and execution across all C&Q phases
- Solid understanding of GMP requirements and regulatory expectations
- Prior experience in equipment FAT support and willingness to travel within the EU is essential
- Excellent planning, problem-solving, and communication skills
-
Sterile Product Manufacturing Leader
5 days ago
Dublin, Dublin City, Ireland beBeeManufacturing Full time €90,000 - €110,000Manager of Sterile Product ManufacturingJob Title: Manager of Sterile Product ManufacturingThis position oversees daily operations, ensuring compliance with regulatory standards and company policies.Key Responsibilities:Oversee the Aseptic Filling Team to ensure cGMP standards are met.Plan and organize job assignments in alignment with production schedules...
-
Commissioning and Qualification Manager
3 days ago
Dublin, Dublin City, Ireland beBeeCleanUtility Full time €100,000 - €130,000Clean Utility Systems SpecialistJob Overview:We are seeking a seasoned Clean Utility Systems Specialist to oversee the commissioning and qualification of clean utility systems for various capital projects. The ideal candidate will ensure that C&Q activities are completed safely, on schedule, and in compliance with GMP and quality requirements.
-
Commissioning & Qualification Engineer
4 weeks ago
Dublin, Dublin City, Ireland Oxford Global Resources Full timeAre you a Commissioning and Qualification Engineer looking for your next challenge? Are you experienced in leading and executing C&Q activities for process and utility systems? If you have recent experience in these activities within the biotech or pharmaceutical industry, you could be the perfect candidate for this opportunity Don't hesitate, apply todayJob...
-
Commissioning & Qualification Engineer
6 days ago
Dublin, Dublin City, Ireland Oxford Global Resources Full timeSocial network you want to login/join with:Commissioning & Qualification Engineer, Dublincol-narrow-leftClient:Oxford Global ResourcesLocation:Dublin, IrelandJob Category:Other-EU work permit required:Yescol-narrow-rightJob Reference:7937cd61750dJob Views:5Posted: Expiry Date: col-wideJob Description:Job DescriptionJob DescriptionOur biotech client based in...
-
Sterile Operations Director
6 days ago
Dublin, Dublin City, Ireland beBeeOperations Full timeAbout the Role:">The Sterile Operations Director is responsible for overseeing the daily operations of a sterile manufacturing environment, ensuring compliance with global regulatory standards and company policies. This role leads the planning, organization, and execution of filling operations, ensuring optimal performance, productivity, and quality.">Key...
-
Dublin, Dublin City, Ireland beBeeCleanUtilities Full time €65,520 - €68,600Exciting Career OpportunityDublin, IrelandA leading Biotechnology company is seeking a highly experienced Clean Utilities Commissioning and Qualification Engineer to join their team at their state-of-the-art manufacturing facility in Dun Laoghaire, South Dublin.This is an exceptional opportunity to advance your career in Ireland's thriving biotech industry....
-
Dublin, Dublin City, Ireland beBeevalidation Full time €90,000 - €120,000Senior Validation EngineerWe are seeking an experienced and skilled professional to join our team as a Senior Validation Engineer. In this role, you will contribute to the Sterile Drug Product Facility project, serving as an integral member of the Commissioning, Qualification, and Validation (CQV) team.Your key responsibilities will include creating and...
-
CQV Engineering Specialist
3 days ago
Dublin, Dublin City, Ireland beBeeCQVEngineer Full time €60,000 - €90,000Job Title: CQV Engineering SpecialistWe are seeking an accomplished CQV Engineer to join our team, focusing on equipment, utilities, and computer systems validation.About the Role:This position involves supporting the Sterile Drug Product Facility project as part of the CQV team.The successful candidate will develop and execute commissioning and...
-
Manufacturing Director, Albumin
3 weeks ago
Dublin, Dublin City, Ireland Grifols Full timeSocial network you want to login/join with:The Albumin Manufacturing Director supports the start-up, qualification and commercialization of the new Albumin Purification and Aseptic Filling Plant.Initially this person will manage the activities to transition the new plant from a start-up project through commissioning, qualification, validation and...
-
Dublin, Dublin City, Ireland Bristol Myers Squibb Full timeOverviewWorking with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that...