Commissioning, Qualification & Validation Engineer

Job Overview CDD for Senior Validation Engineer, MSAT-CQV Team - All genders // CDD pour un poste d’ingénieur validation senior

The Senior Validation Engineer supports CQV facility start‑up activities including cleaning validation, autoclave validation and disinfection study.

Primary Responsibilities

Support the generation and/or review of key deliverables including User Requirements Specifications, System Impact Assessments, Criticality Assessments, Data Integrity Assessments, Design Qualification, Requirements Traceability Matrices, FAT, SAT, Commissioning, IQ and OQ protocols for autoclave and part washer performed by our external partners

Generate, review and approve key deliverables related to the autoclave validation: Determination of worst case, risk assessment, PQ protocol generation; support and follow‑up the PQ execution

Supervise a contingent worker in charge of cleaning validation to apply a strategy compliant with regulations; review and approve key deliverables, supervise and coordinate cleaning validation execution

Follow and support the efficacy study of disinfectant performed by a service provider; generate the final report to validate the effectiveness of disinfectants against microorganisms in ZAC

Collaborate with a multi-disciplinary team: external partners, consultants, process engineers, Automation, E&HS, Quality

Assure that the schedule of generation of CQV documentation is on track

Contribute to validation deviation resolution including troubleshooting and root cause analysis

Perform periodic review and requalification of qualified equipment, systems and utilities to ensure the system remains suitable for its intended use and to verify compliance with appropriate industry regulations and company policies

Support the development of the qualification and validation programs

Develop phase‑appropriate ways to comply with regulatory requirements

Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings

Requirements

Master’s degree in engineering science or related program with ~minimum 3 years of relevant experience

Understanding of industry standards and best practices for a science and risk‑based approach to qualification of systems, equipment, utilities and facilities

Experience in cleaning and autoclave validation

Experience in disinfectant efficacy studies

Experience in working knowledge of US FDA CFRs and European EMA, including ICH regulations

Experience authoring and reviewing validation documentation

Experience with quality risk management

Experience with sampling techniques and cleaning and autoclave cycle development

Knowledge of process equipment, utilities, operations and engineering principles

Must possess a strong focus on quality and attention to detail

Must possess problem‑solving and critical‑thinking skills

Motivated, self‑starter with strong mechanical aptitude

Ability to work both independently and collaboratively across multiple disciplines in a fast‑paced and dynamic environment

Possess effective task/time management and organizational skills

Additional Preferred Qualifications

Significant contributor to multi‑disciplinary teams at the functional level

Experience performing swab and rinse sample collection

Experience with soils analysis, detergent analysis and MACO (Maximum Allowable Carry Over) calculations

Verbal and written communication skills in both English and French

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

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