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 TitleValidation & Compliance EngineerLocation(s)MSD (Switzerland) - Customer Site
Job Description
Performs the calibration of simple laboratory devices such as pipettes and data loggers.
Performs the review and validation of test and data analysis equipment and systems used for clinical research, trials and product testing. Maintains all documentation pertaining to maintenance, qualification and repair, both originals and electronic records into Customer systems. In constant direct contact with Customer stakeholders, works closely with Customer and workflow specialists’ colleagues in translating maintenance plan into operational scheduling. Works closely with EHS to grant Vendor vetting procedures, as well as Safety processes are duly executed by both internal personnel and External Service Providers (ESP). Convoys ESP across Customer site, acting as her/his responsible person. Also serves as information resource for validation technicians, contractors, and vendors. Contribute with Customer QA and Technical Unit in developing and implementing new specifications. Contribute in change management and deviation tracking processes, including leading or contributing to CAPA. May contribute to developing procedures and/or protocols.
Responsibilities:
Calibration Lab
Performs calibration of simple laboratory instruments, including but not limited to pipettes and data loggers, within LAMP internal calibration laboratory.
Administration LAMP
Works closely with Scheduling & Planning team to manage shipping and reception of assets for external services (calibration, maintenance, repair)
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 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.
Top Skills
What We Do
For 85 years, PerkinElmer has pushed the boundaries of science from food to health to the environment. We’ve always pursued science with a clear purpose – to help our customers achieve theirs. Our expert team brings technology and intangibles, like creativity, empathy, diligence, and a spirit of collaboration, in equal measure, to fulfill our customers’ desire to work better, innovate better, and create better.
PerkinElmer is a leading, global provider of technology and service solutions that help customers measure, quantify, detect, and report in ways that help ensure the quality, safety, and satisfaction of their products.
Learn more at www.newperkinelmer.com.
