Gain a working knowledge of laboratory equipment to facilitate with troubleshooting and/or communicate with the vendor/ service engineer to identify resolutions
Participate in computer system validation activities associated with 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 new SOP drafting, implementation, and revisions.
Represent the laboratory on all aspects of laboratory equipment during audits.
Ensure compliance with all regulatory requirements (cGMP), internal policies and procedures.
Customer focused mindset with the ability to communicate adequately (verbally/writing) to all levels within the organization.
Willingness and ability to quickly upskill Facilities/Instrument support programs SAP, ProCal, BAS, LAMP, Electronic Validation, and other document and/or asset repositories
Initiate, process and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.
Calibration Focus:
Prepare, review, and approve archive instrument/equipment documentation such as master equipment lists, user access reviews, Instrument Installation & operational qualification documentation, and calibration documentation.
Coordinate service activities across a variety of vendors and service engineers while building and maintaining strong working relationships.
Collaborate with metrology staff across multiple testing labs and sites for process improvement, cross-training and cross-site support.
Support the purchase, installation, and equipment qualification of new laboratory equipment.
General Requirements Level:
2-4 years of experience participating in the validation of computerized laboratory systems or instruments (e.g. system Installation and Operational qualification, Performance qualification
Experience working in a GMP environment and maintaining laboratory equipment.
Highly organized, strong communication skills.
Capable of working independently.
Solutions orientated mindset with the ability to handle multiple high priority tasks at one time.
Ability to succeed in a dynamic environment; flexibility to respond to changing priorities.
Awareness to independently prioritize tasks and responsibilities based on actual or perceived level of importance and/or potential impact to the GMP environment.
