This Spear Group full-time employee Metrology Specialist opportunity presents the opportunity to know the biopharma lab equipment best practices of today and keep up with the latest technology in bioprocessing and R&D. This position supports our top global biopharma client by acting as a liaison with the company’s lab asset management, the equipment / instrument vendor, and the laboratory space for equipment and instrumentation –for multiple departments. This position will also manage the system lifecycle of an instruments/equipment - from purchasing, installing, and qualifying new systems through to the equipment retirement cycle. This role is responsible for coordinating all metrology activities and ensuring completion of applicable GMP training prior to performing tasks and key GxP activities.
Key Responsibilities:
Prepare, review, and approve instrument/equipment documentation such as master equipment lists, qualification documentation, and calibration documentation
Coordinate service activities against applicable GMP calibration schedules across a variety of vendors and service engineers
Participate in System Development Lifecycle activities (SDLC) associated with new or upgraded equipment or software packages
Serve as System Administrator of GMP stand-alone lab instruments and/or supporting applications (e.g. OpenLab, Acronis, GIMAS, etc.)
Serve as Owner/Approver of shared data access.
Support the purchase, installation and equipment qualification of new laboratory equipment
Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support
Originate deviations and Corrective & Preventive Actions (CAPAs)
Originate Change Management (CM) records
Serve as a change owner and representative for business area approval of change records.
Author and contribute to Standard Operating Procedures (SOP) drafting, implementation, and revisions
Represent the laboratory on all aspects of laboratory equipment during audits
Originate and ensure timely completions of metrology related audit responses and CAPAs
Inform Management of non-conforming issues
Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures
Maintains up-to-date training in cGMPs as needed
Required Experience and Education:
Minimum of 3-5 years’ experience applying the knowledge, principles, and practices relevant to calibration and instrumentation including lab instrumentation / equipment life cycle activities.
Bachelor’s degree in engineering or related degree. Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
Work experience where attention to detail and personal accountability were critical to success
Demonstrates good interpersonal skills, is attentive and approachable.
Computer literate in computer based calibration program highly desirable.
Knowledge of principles/practices relevant to calibration and instrumentation.
General understanding of operating principles of industrial instrumentation and control systems.
Knowledge of both calibration and maintenance of instrumentation on biotech manufacturing equipment.
Compensation based of relevant experience
EQUAL OPPORTUNITY EMPLOYER
The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.
