Validation & Compliance Engineer

PerkinElmer; Schachen; Hybrid; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

PerkinElmer is seeking a Validation & Compliance Engineer to support the production environment at the Customer site (MSD) in Schachen. The role requires validating equipment and systems for manufacturing, maintaining qualification documentation, and collaborating with QA and technical units to implement specifications.

The candidate should have 3–5 years in pharma quality/validation, knowledge of cGMP and regulatory guidelines. English is essential; German is a plus.

Qualifikationen

• Bachelor’s degree in Life Sciences or Quality/Compliance.
• 3–5 years in (Bio-)Pharma quality, validation or compliance.
• Knowledge of cGMP, Annex 1 and validation regulations.
• Strong written and verbal English; German language knowledge is a plus.
• Ability to work independently and in a team; follow customer SOPs and regulatory guidelines (FDA, EU, SwissMedic).

Aufgaben

• Review and validate test and data analysis equipment and systems used for manufacturing phases 1 and 2.
• Maintain documentation for maintenance and qualification/calibration in customer systems.
• Develop procedures and/or protocols as needed.
• Serve as information resource for validation technicians, contractors and vendors.
• Collaborate with Customer QA and Technical Unit on developing and implementing specifications.
• Contribute to change management and deviation tracking processes, including CAPA.

Kenntnisse

Communication skills

English proficiency

German knowledge

Attention to detail

Independent & Team work

Ausbildung

Bachelor’s degree in Life Sciences or Quality/Compliance

Jobbeschreibung

PerkinElmer's OneSource team is looking for a Validation & Compliance Engineer to support production environment on the Customer site (MSD) in Schachen. More information about PerkinElmer and our business : PerkinElmer | Science with Purpose More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer Hybrid working model

Responsibilities

• Performs the review and validation of test and data analysis equipment and systems used for phase 1 and phase 2 manufacturing.
• Maintains all documentation pertaining to maintenance and qualification/calibration, both original and electronic records into Customer systems.
• May contribute to developing procedures and/or protocols.
• Serves as information resource for validation technicians, contractors and vendors.
• Contribute with Customer QA and Technical Unit in developing and implementing new specifications.
• Contribute to change management and deviation tracking processes, including leading or contributing to CAPA.

Requirements

• Bachelor’s degree in Life Sciences or Quality/Compliance discipline or equivalent experience preferred.
• 3 to 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, GDocP, pharmacopeia and regulatory requirements preferred.
• Developed Customer service mindset
• Be passionate about detail and tech aspects
• Strong written and verbal communication skills in English, German language knowledge will be beneficial.
• Ability to work both independently and as a team member
• Following customer SOPs and regulatory guidelines FDA, EU & SwissMedic

Join our Team!

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