Validation & Compliance Engineer

PerkinElmer; Luzern; Hybrid; CHF 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Hybrid working model

Zusammenfassung

PerkinElmer is seeking a Validation & Compliance Engineer to support production activities at the MSD Customer site in Schachen. The role is within the OneSource team and features a hybrid working model with emphasis on validation, qualification, and compliance in a GMP environment.

You will review and validate equipment and systems, maintain qualification documentation, and collaborate with QA, vendors, and customers to ensure adherence to cGMP and regulatory guidelines.

Qualifikationen

• Bachelor’s degree in Life Sciences or Quality/Compliance is required.
• 3–5 years of relevant experience 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.
• Strong attention to detail and technical aspects.

Aufgaben

• 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.

Kenntnisse

Communication skills

Customer service mindset

Detail oriented

Team player

Ausbildung

Bachelor’s degree in Life Sciences or Quality/Compliance

Jobbeschreibung

Validation & Compliance Engineer

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 (opens in new window)

More information about our OneSource services: OneSource Laboratory Solutions | PerkinElmer (opens in new window)

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!

We are strongly committed to the development of your career and giving you opportunities to learn and grow.

We make a difference for you while you make a difference in the world!