Senior Validation & Compliance Engineer

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

Senior Validation & Compliance Engineer

Location(S)

MSD (Switzerland) - Customer Site

You perform and coordinate Laboratory Asset Management Program (LAMP) activities.

Calibration Lab

• Supervises operations, including but not limited to protocols, instrument/reference devices’ calibration and consumables management.
• Performs calibration of simple laboratory instruments, including but not limited to pipettes and dataloggers, within LAMP internal calibration laboratory.

Administration Lamp

• Works closely with Scheduling & Planning team to manage shipping and reception of assets for external services that can’t be performed internally (calibration, maintenance, repair)
• Actively contributes in identifying and implementing Manage to Maintain (M2M) conversions, insourcing maintenance and calibration of devices whenever reasonable.
• Actively contributes to keep updated operational system of records, by adding/amending records to reflect Customer driven changes impacting LAMP / OneSource services’ scope.
• Supports Scheduling & Planning team with External Service Providers (ESP) management: Quality and EHS screening, training, escorting within Customer site.

Document Review & Approval

• Reviews and approves documents as part of calibration, maintenance, and repair work
• Collaborate closely with internal and external Calibration & Maintenance Engineers, to close eventual GDP gaps in provided documentation.
• Closely collaborate with Equipment Owners (EO) to releases assets after successful completion of calibration, maintenance, and repair work
• Processes Changes, Temporary Changes, Deviations, and CAPA related with calibration and maintenance.
• Contributes to changes and investigations as a member of cross-functional teams.

Data Management / Administrative Release

• Adds, updates, reviews, and releases positions in the Customer calibration (CCMS) and maintenance (CMMS) databases.
• Reviews, approves, and performs administrative release of successful calibration and maintenance entries in Customer CCMS/CMMS systems.

Basic Qualifications

• Bachelor’s degree in a Life Sciences, Engineering or Quality/Compliance discipline or equivalent experience preferred.
• Minimum of five (5) years of relevant experience in a (Bio-)Pharma company in quality, validation or compliance roles in GMP environment. In alternative, equivalent in-lab experience can be considered.

Preferred Characteristics

• GxP hardware and/or software experience preferred.
• Knowledge of cGMP and validation regulations and requirements.
• Knowledge of GMP, GLP, GDP, pharmacopeia and regulatory requirements.
• Developed Customer service mindset.
• Be passionate in attention to detail and tech aspects.
• Strong written and verbal communication skills in English (required), German (strongly preferred). Any additional language would be a plus.
• Ability to work both independently and as a team member, within prescribed guidelines, coping with frequent grey areas / uncertainty.