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Senior Validation & Compliance Engineer
Schachen Switzerland
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Responsibilities
Location Schachen, LucerneCH Job ID REQ-055826
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.
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PerkinElmer is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.
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