Instrument Validation Specialist

Roles & Responsibilities:

Gain a working knowledge of laboratory equipment to facilitate 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 in Client Facilities/Instrument support programs SAP, ProCal, Client, LAMP, Electronic Validation, and another document and/or asset repositories.

Initiate, process, and track work orders to facilitate timely repairs, modifications and moves of laboratory equipment.

Requirements:

Specialist I focus commensurate with degree and experience requirements.

Validation: Bachelor's degree in biological or chemical science and/or engineering plus 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.