Validation & Compliance Engineer

PerkinElmer; Schweiz; Sur place; EUR 118 944 - 151 383; Plein temps

Résumé du poste

MSD Switzerland is seeking a Validation & Compliance Engineer to ensure GxP-compliant calibration, maintenance, and repair activities at a customer site. You will review documentation, manage CAPAs and deviations, and release assets for use.

You will collaborate with Calibration & Maintenance Engineers to sustain regulatory compliance, contribute to investigations, and maintain CCMS/CMMS records. Strong communication and attention to detail are essential.

Qualifications

• Bachelor's degree or equivalent in Life Sciences or Quality/Compliance. (preferred)
• Minimum 5 years in quality, validation or compliance in a (Bio-)Pharma company
• Knowledge of cGMP, Annex 1 and validation regulations

Responsabilités

• Review and approve documentation for calibration, maintenance, and repair activities
• Release assets for use and manage changes, deviations, and CAPAs
• Collaborate with Calibration & Maintenance Engineers to maintain GxP compliance
• Release assets after successful calibration, maintenance, and repair
• Process changes, temporary changes, deviations, and CAPA related to calibration and maintenance
• Contribute to changes and investigations as part of cross‑functional teams
• Add, update, review, and release positions in CCMS/CMMS databases
• Review and release calibration and maintenance entries in CCMS/CMMS systems

Connaissances

Quality Assurance

cGMP Knowledge

Regulatory Knowledge

Attention to Detail

Communication Skills

Teamwork

Customer Service Mindset

Documentation Skills

Formation

Bachelor's degree in Life Sciences or Quality/Compliance

Description du poste

Job Title

Validation & Compliance Engineer

Location

MSD (Switzerland) – Customer Site

Responsibilities

• Review and approve documentation for calibration, maintenance, and repair activities
• Release assets for use and manage changes, deviations, and CAPAs
• Collaborate closely with Calibration & Maintenance Engineers to keep operations GxP-compliant
• Release assets after successful completion of calibration, maintenance, and repair work
• Process changes, temporary changes, deviations, and CAPA related with calibration and maintenance
• Contribute to changes and investigations as a member of cross‑functional teams
• Add, update, review, and release positions in the Customer calibration/maintenance databases (CCMS/CMMS)
• Review, approve, and perform administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems

Qualifications

• Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience (preferred)
• Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles
• Knowledge of cGMP, Annex 1 and validation regulations and requirements
• Knowledge of GMP, GLP, GDP, pharmacopeia, and regulatory requirements (preferred)
• Developed customer service mindset
• Passion for detail and technical aspects
• Strong written and verbal communication skills
• Ability to work both independently and as a team member within prescribed guidelines, coping with frequent grey areas / uncertainty