Responsibilities
Location Schwabenheim an der Selz, Rhineland-PalatinateDEJob ID REQ-052344PerkinElmer is looking for a Service Support Specialist to reinforce our SSV team based at out Customer´s site in Schwabenheim, Germany. You will join our on-site team, to perform and coordinate Laboratory Asset Management Program (LAMP) activities at the Customer site.
Administration LAMP
Works closely with Scheduling & Planning team to manage shipping and reception of assets for external services (calibration, maintenance, repair)
Actively contributes in keeping 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
Requirements
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 alternative, equivalent in-lab experience can be considered.
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.