Validation Engineer

Katalyst CRO; Cambridge (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical technology firm in Cambridge, Massachusetts is seeking a seasoned Validation Engineer with over 10 years of experience in regulated manufacturing. The ideal candidate will have expertise in validation protocol development for both new and existing processes, and must be proficient in regulatory compliance with standards such as ISO 13485 and FDA regulations. Strong technical writing skills and the ability to work independently across projects are essential for this role.

Qualifications

• 10+ years of experience in medical device or regulated manufacturing environments.
• Strong hands-on expertise in validation protocols for manufacturing processes.
• Working knowledge of regulatory frameworks, including ISO 13485 and FDA 21 CFR 820.

Responsibilities

• Develop and execute IQ/OQ/PQ protocols for new and legacy processes.
• Author protocols, deviation reports, and validation summaries.
• Collaborate cross-functionally with various teams for validation workstreams.

Skills

IQ/OQ/PQ protocol development

Test Method Validation (TMV)

Computerized System Validation (CSV)

Statistical methods

Technical writing skills

Job description

• 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.