Validation & Compliance Engineer
| Job ID | REQ-058081 |
| Location | Schachen, Entlebuch District, Canton of Lucerne |
| Job Type | Regular |
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!
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!