Commissioning, Qualification & Validation Engineer

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.

• Supervision of 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 tovalidate the effectiveness of disinfectants against microorganisms in ZAC

• Collaborate with 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 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 Degree in engineering science or related program with ~min 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 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 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 communications 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.