Metrology Specialist
Vita Global Sciences, a Kelly Company · West Point, PA · 1 mo ago
On-siteOTHRContract
Kelly Science and Clinical FSP is seeking a Metrology Specialist I for a long‑term, full‑time engagement with a global pharmaceutical client in West Point, PA. The position is 100 % on‑site and includes full benefit options.
Responsibilities
- Manage equipment assets at multiple locations.
- Develop working knowledge of laboratory equipment to troubleshoot issues and communicate with vendors or service engineers to identify resolutions.
- Participate in computer system validation activities for new or upgraded equipment or software packages.
- Originate and progress deviations and change‑control records.
- Perform and document investigations and assist in developing and implementing CAPA plans.
- Contribute to drafting, implementing, and revising standard operating procedures (SOPs).
- Represent the laboratory on all aspects of equipment during audits.
- Ensure compliance with regulatory requirements (cGMP), internal policies, and procedures.
- Maintain a customer‑focused mindset and communicate effectively (verbally and in writing) at all organizational levels.
- Upskill in facilities/instrument support programs such as SAP, ProCal, BAS, LAMP, electronic validation, and other document or asset repositories.
- Initiate, process, and track work orders to facilitate timely repairs, modifications, and moves of laboratory equipment.
- Prepare, review, and approve archived instrument/equipment documentation, including master equipment lists, user‑access reviews, installation & operational qualification documents, and calibration records.
- Coordinate service activities across a variety of vendors and service engineers while building strong working relationships.
- Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross‑training, and cross‑site support.
- Support purchase, installation, and qualification of new laboratory equipment.
- Qualify and validate computerized analytical systems according to current guidelines.
- Partner with business units, quality support, IT technical support, and software/instrument vendors/manufacturers.
- Perform required change control throughout the lifecycle of computerized systems and decommission systems as needed.
- Manage capital purchasing and initial installation of computerized analytical systems prior to validation.
- Participate in data integrity and laboratory modernization activities.
- Operate analytical instrumentation within a pharmaceutical or equivalent laboratory (vaccine or large‑molecule focus) and thoroughly review validation requirements throughout the system lifecycle.
Requirements
- Bachelor’s degree in biological or chemical science and/or engineering.
- 2–4 years of experience participating in validation of computerized laboratory systems or instruments (e.g., installation, operational qualification, performance qualification).
- Experience working in a GMP environment and maintaining laboratory equipment.
- Highly organized with strong communication skills.
- Capable of working independently and handling multiple high‑priority tasks simultaneously.
- Solutions‑oriented mindset with flexibility to respond to changing priorities.
- Ability to prioritize tasks based on importance and potential impact to the GMP environment.
Benefits
- Medical, dental, and vision insurance.
- 401(k) retirement plan.
- Additional benefit options to choose from.
- Paid time off, including holidays, vacation, and sick/personal time.
Schedule
Full‑time, 100 % on‑site in West Point, PA.