Address
Form of work Responsibilities:
- 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 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.
- 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.
