Validation Engineer

Katalyst CRO; Manchester (NH); Presencial; USD 120.000 - 170.000; Jornada completa

Descripción de la vacante

Katalyst CRO is seeking a seasoned Validation Engineer with 10+ years in medical device or regulated manufacturing. You will lead IQ/OQ/PQ protocol development, TMV and CSV under GAMP 5, and ensure compliance with ISO 13485, ISO 14971, EU IVDR, and FDA regulations.

You will author validation documents and drive cross-functional validation workstreams across Quality, Manufacturing, R&D, QC, Regulatory Affairs, and IT.

Formación

• 10+ years of experience in medical device or regulated manufacturing environments.
• Hands-on expertise in IQ/OQ/PQ protocol development and execution, TMV and CSV per GAMP 5.
• Solid knowledge of ISO 13485, ISO 14971, EU IVDR 2017/746 and FDA 21 CFR 820; ability to develop Master Validation Plans and CTQ-based acceptance criteria.
• Ability to establish traceability across risk controls, process parameters, and validation outputs; PFMEA and change control impact assessments.
• Proficiency in statistical methods used in validation (MSA, process capability analysis, sampling plan design).
• Familiarity with CLSI guidelines and ISO 15189 for analytical/diagnostic method validation is a plus (IVD focus).
• Strong technical writing skills and experience authoring protocols, deviation reports, and validation summaries for regulatory scrutiny.
• Cross-functional collaboration with Quality, Manufacturing, R&D, QC, Regulatory Affairs, and IT to drive validation workstreams.

Responsabilidades

• Develop and execute IQ/OQ/PQ protocols for new and legacy processes/equipment.
• Manage TMV and CSV validation activities in line with GAMP 5.
• Create and maintain Master Validation Plans and risk-based validation outputs.
• Define CTQ-based acceptance criteria and ensure traceability across controls and parameters.
• Lead PFMEA and change control impact assessments; drive validation across multiple projects.
• Apply statistical tools (MSA, capability analysis, sampling plans) to validation activities.
• Collaborate with Quality, Manufacturing, R&D, Regulatory Affairs, and IT to advance validation milestones.

Conocimientos

IQ/OQ/PQ protocol

Test Method Validation

CSV validation

GAMP 5

ISO 13485

ISO 14971

FDA 21 CFR 820

EU IVDR 2017/746

Master Validation Plans

CTQ criteria

Traceability

Risk controls

Process parameters

Validation outputs

PFMEA

Change control

MSA

Process capability

Sampling plan

CLSI guidelines

ISO 15189

IVD focus

Technical writing

Cross-functional collaboration

Descripción del empleo

• 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.