Validation Engineer
Cambridge, MA · On-site
... System Validation (CSV) in accordance with GAMP 5. * A solid working knowledge of regulatory ... Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs ...
Validation & Engineering Group
61 Validation Engineering Group System Validation Engineer Jobs Hiring Near You
Validation Engineer
Cambridge, MA · On-site
... System Validation (CSV) in accordance with GAMP 5. * A solid working knowledge of regulatory ... Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs ...
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Posted 28 days ago
Job description
Roles & Responsibilities:
- We are seeking a seasoned Validation Engineer with 10+ years of experience in medical device or regulated manufacturing environments.
- Candidates must have strong hands-on expertise in IQ/OQ/PQ protocol development and execution for both new and legacy manufacturing processes and equipment, as well as Test Method Validation (TMV) and Computerized System Validation (CSV) in accordance with GAMP 5.
- A solid working knowledge of regulatory frameworks is essential - specifically ISO 13485, ISO 14971, EU IVDR 2017/746, and FDA 21 CFR 820 - along with demonstrated ability to develop and maintain Master Validation Plans, define CTQ-based acceptance criteria, and establish traceability across risk controls, process parameters, and validation outputs.
- Experience with PFMEA and change control impact assessments is also expected.
- On the analytical side, candidates should be proficient in statistical methods used in validation, including Measurement System Analysis (MSA), process capability analysis, and sampling plan design.
- Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus given the IVD product focus.
- Strong technical writing skills are a must - this person will be authoring protocols, deviation reports, and validation summaries that must hold up to regulatory scrutiny.
- Cross-functional collaboration with Quality, Manufacturing Engineering, R&D, QC, Regulatory Affairs, and IT is a core part of the day-to-day, so candidates should be comfortable driving validation workstreams independently across multiple concurrent projects.
About Katalyst Healthcares & Life Sciences
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Katalyst HealthCares & Life Sciences is a Global Contract Research Organization that provides services in Clinical Research, Manufacturing & Quaity, Regulatory Affairs Areas.. Industries Serving: Pharmaceutical Bio-Pharmaceutical Medical Device Cosmeceuticals & Cosmetics Food & Beverage Clinical Research Scientific Areas Covering: Clinical Research Manufacturing Quality & Validations Regulatory Affairs Intellectual Property Through our in-house team expertise, associates and alliances in the US, Europe and Asia, we can rapidly deliver services, technology, processes and workforce globally, either virtually or integrate into client project space, providing oversight and expertise for individual needs to total end-to-end support for all kinds of clinical trials of Pharma, Biotech, Medical Device and all other scientific products and their manufacturing.
Industry
Scientific research and development services
Company size
51 - 200 Employees
Headquarters location
South Plainfield, NJ, US