Biotech Validation Expert
3 days ago
Life Science Recruitment is seeking a highly skilled Biotech Validation Expert to join an award-winning Pharmaceutical organization in Dublin. This is an excellent opportunity for a professional looking to work with a leading multinational company that excels in its field.
Duties- Oversee validation activities at External Manufacturing sites (API, DS/DP), including process, cleaning, filter and sterilization/sanitization validation.
- Audit and approve validation documents.
- Ensure validated parameters are correctly incorporated in Master Batch Records.
- Oversight of Aseptic processing system, including media fill, autoclave validation and EM content authorship.
- Assess validation change control.
- Perform Person in Plant activities as required.
- Author applicable MA filing sections.
- Write/review RTQs.
- Prepare inspection playbooks.
- Present on topics during inspection demonstrating appropriate behaviours and knowledge of the subject areas.
- Drive Operational Excellence and Champion Change.
- Determine validation strategy and outcome of validation activities.
- Approve or reject validation documentation.
An ideal candidate will have a degree in science and/or engineering and 5+ years of experience in the biotech or pharmaceutical industry, with significant validation experience at Aseptic Manufacturing or API facilities.
-
Biotech Validation Engineer
8 hours ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeJob DescriptionPSC Biotech Corporation is a global biotechnology consulting firm founded in 1996. We are currently seeking an experienced Validation Engineer Specialist to join our team in Carlow, Ireland.The successful candidate will have a degree-level qualification in applied pharmaceutical or biological sciences, with significant experience in GMP...
-
Lead Manufacturing Biotech Associate
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia, and the US, serving...
-
Lead Manufacturing Biotech Associate
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Meath State/Province Meath Country Ireland Job Description About PSC Biotech PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving...
-
Validation Specialist
8 hours ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timePSC Biotech Corporation OverviewPSC Biotech is a leading biotech consultancy firm with a global presence in Ireland, India, Singapore, Australia, and the US. We serve 350 clients across 23 countries worldwide.About Our CompanyAt PSC Biotech, we provide cloud-based software solutions for quality management and regulatory inspections, catering to...
-
Validation Engineer
5 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout PSC BiotechWho are we?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory...
-
Pharmaceutical Validation Expert
8 hours ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout PSC Biotech CorporationWe are a leading Biotech Consultancy firm providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients worldwide.The successful candidate will be part of a high-performing team that can exceed client...
-
Validation Engineer Specialist-Shift
12 hours ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical ResearchWork Experience 4-5 yearsCity CarlowState/Province CarlowCountry IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more...
-
Senior Validation Engineer-Hybrid
10 hours ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 4-5 yearsCity: CarlowState/Province: CarlowCountry: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in...
-
Validation Specialist
5 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeAbout PSC Biotech CorporationPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in the USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide.We provide cloud-based software solutions for Quality Management and Regulatory Inspections,...
-
Process Development Expert
5 days ago
Dublin, Dublin City, Ireland PSC Biotech Full timeAbout PSC BiotechWe are a Biotech Consultancy firm founded in 1996 with headquarters in Pomona, California, USA, and global operations in multiple countries.We provide cloud-based software solutions for Quality Management and Regulatory Inspections to pharmaceuticals contract manufacturing professionals.Job Summary:This is an exciting opportunity to join our...
-
Pharmaceutical Validation Expert
8 hours ago
Dublin, Dublin City, Ireland Mason Alexander Full timeMason Alexander is partnering with a prominent pharmaceutical company in Wicklow to fill a permanent Validation Engineer position.This is a fantastic opportunity to work closely with our Quality & Regulatory team, focusing on performing and executing validation and qualification duties for all projects across the site.In this role as a Validation...
-
Biologics Manufacturing Operations Expert
6 days ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timePSC Biotech is a global leader in biotech consultancy, providing innovative solutions for quality management and regulatory inspections.About Our TeamWe are a dynamic team of experts dedicated to delivering exceptional results and exceeding client expectations.We prioritize career development and employee growth, offering opportunities for professional...
-
QC Systems Validation Engineer
6 days ago
Dublin, Dublin City, Ireland Psc Biotech Corporation Full timeJob SummaryPSC Biotech Corporation seeks a skilled QC Systems Validation Engineer to join our dynamic team. As a key member of our Quality Control group, you will be responsible for maintaining the testing infrastructure of our QC lab, ensuring all materials used for our products meet our high standards of quality and regulatory requirements. The ideal...
-
Validation Services Manager
2 days ago
Dublin, Dublin City, Ireland The Rovisys Company Full timeCompany OverviewThe Rovisys Company is a leading provider of validation services to the pharmaceutical, biotechnology, and medical device industries. Our team of experts works closely with clients to ensure compliance with regulatory standards and drive business growth.We are seeking an experienced and motivated Validation leader to develop and lead a...
-
15h Left) Tech Transfer Lead
2 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Full time- Industry: Pharma/Biotech/Clinical Research- Work Experience: 5+ years- City: Dublin- State/Province: Dublin- Country: IrelandJob DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...
-
Validation Engineer
2 weeks ago
Dublin, Dublin City, Ireland The Aphex Group Full timeWe are seeking an experienced Validation Engineer with expertise in Vial and Syringe Filling operations for a leading biotech facility. The ideal candidate will have broad experience in the following areas:Sterile Operations (Isolators, VHP, Decontamination)Single Use Technologies (SUT) and Filter ValidationAncillary Equipment (Tube Welders, Glove Integrity...
-
Senior Specialist in Analytical Science
4 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Full timeJob DescriptionAbout PSC BiotechWho we are?PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and...
-
Tech Transfer Lead
4 weeks ago
Dublin, Dublin City, Ireland PSC Biotech Corporation Full timeIndustry Pharma/Biotech/Clinical Research Work Experience 5+ years City Dublin State/Province Dublin Country Ireland Job DescriptionAbout PSC BiotechPSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350...
-
Biotech Engineer Specialist
7 hours ago
Dublin, Dublin City, Ireland TN Ireland Full timeJob DescriptionWe are seeking a skilled Biotech Engineer Specialist to join our team at TN Ireland. In this role, you will support various aspects of validation, including Sterilisation – Autoclaves, SIP of vessels, Cleaning – Parts Washer and CIP of vessels, Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and...
-
Quality Assurance Engineer
5 days ago
Dublin, Dublin City, Ireland PSC Biotech Full timeAbout PSC BiotechWe are a leading Biotech Consultancy firm with a strong track record of innovation and excellence in the industry.Our EVP includes empowering career development through Learning & Development in-house training mentorship and constant guidance to facilitate career progression.Job Overview:This is an exciting opportunity to join our Process...