Hybrid Validation & Compliance Engineer - Production Systems

PerkinElmer; Canton (OH); Hybrid; USD 109,000 - 146,000; Full time

Job summary

PerkinElmer's OneSource team seeks a Validation & Compliance Engineer to support the production environment on the Customer site (MSD) in Schachen. The role focuses on reviewing and validating equipment, maintaining calibration records, and collaborating with QA and Technical Units to implement specifications.

Candidates should have 3–5 years in quality/validation within a (Bio-)Pharma setting, knowledge of cGMP and regulatory standards, and strong communication skills in English; German is a

Qualifications

• Bachelor’s degree in Life Sciences or Quality/Compliance 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 beneficial.
• Ability to work both independently and as a team member.
• Follow customer SOPs and regulatory guidelines FDA, EU & SwissMedic.

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.

Skills

Attention to detail

Communication skills

English proficiency

German language knowledge

Independent work

Education

Bachelor’s degree in Life Sciences or Quality/Compliance

Job description

PerkinElmer's OneSource team seeks a Validation & Compliance Engineer to support the production environment on the Customer site (MSD) in Schachen. The role focuses on reviewing and validating equipment, maintaining calibration records, and collaborating with QA and Technical Units to implement specifications.

Candidates should have 3–5 years in quality/validation within a (Bio-)Pharma setting, knowledge of cGMP and regulatory standards, and strong communication skills in English; German is a