Validation & Compliance Engineer

PerkinElmer; Canton (OH); Ibrido; USD 109.000 - 146.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Attention to detail

Communication skills

English proficiency

German language knowledge

Independent work

Formazione

Bachelor’s degree in Life Sciences or Quality/Compliance

Descrizione del lavoro

Job ID REQ-058081

Location Schachen, Entlebuch District, Canton of Lucerne

Job Type Regular

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

More information about our OneSource services: PerkinElmer | 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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We make a difference for you while you make a difference in the world!