PerkinElmer

Analytical instruments and software for health

Validation & Compliance Engineer

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeSchächen, SwitzerlandNo salary listed

About the Job

Requirements

A bachelor's degree in Life Sciences or a Quality/Compliance discipline, or equivalent experience, is preferred.
Three to five years of relevant experience in quality, validation, or compliance roles at a biopharmaceutical company.
Knowledge of current Good Manufacturing Practice, Annex 1, and validation regulations and requirements.
Knowledge of Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice, pharmacopeia, and regulatory requirements is preferred.
A customer-service mindset.
Attention to detail and technical aspects.
Strong written and verbal communication skills in English.
German language knowledge is beneficial.
Ability to work independently and as a team member.
Ability to follow customer standard operating procedures and regulatory guidelines, including FDA, EU, and Swissmedic requirements.

Responsibilities

Review and validate test and data-analysis equipment and systems used for phase 1 and phase 2 manufacturing.
Maintain documentation pertaining to maintenance and qualification/calibration, including original and electronic records in customer systems.
Contribute to developing procedures and/or protocols.
Serve as an information resource for validation technicians, contractors, and vendors.
Contribute with Customer Quality Assurance and the Technical Unit to developing and implementing new specifications.
Contribute to change-management and deviation-tracking processes, including leading or contributing to corrective and preventive actions.

Desired Qualifications

Knowledge of Good Manufacturing Practice, Good Laboratory Practice, Good Documentation Practice, pharmacopeia, and regulatory requirements.
German language knowledge.

When joining PerkinElmer, you select an experienced and trusted leader in scientific solutions, with the support of a global service network and distribution centers, providing the right solution, at the right time, to meet critical customer needs. With over an 80+ year legacy of advancing science and a mission of innovating for a healthier world, our dedicated team collaborates closely with commercial, government, academic and healthcare customers to deliver our broad portfolio of analytical solutions, and OneSource services.

Job Title

Validation & Compliance Engineer

Location(s)

MSD (Switzerland) - Customer Site

Job Description

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!

About the Company

PerkinElmer

Analytical instruments and software for health

PerkinElmer provides analytical instruments, software, and services for the life sciences, diagnostics, and environmental health markets. Customers use these tools to collect and analyze data through a combination of hardware, consumable supplies, and software licensing. Unlike many competitors, the company integrates a global service network with a focus on sustainability by designing products that reduce waste and energy consumption. Its goal is to improve human and environmental health by helping laboratories and industrial companies achieve more efficient and accurate scientific results.

Company size: 5,001-10,000
Company stage: IPO
Headquarters: Shelton, CT
Founded: 1937

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