Regarding calibration duties, this individual will be responsible for performing and coordinating calibrations to ensure that all facility instrumentation is calibrated properly, on schedule, and in compliance with cGMP requirements. This includes maintenance, troubleshooting, calibration, and repair, on a variety of complex instrumentation for research, manufacturing, and quality control applications.
As for validation duties, this individual will prepare, execute, and summarize validation protocols and periodic reviews and assist in the development of other validation related documents (risk assessments, validation plans, trace matrix, specifications, etc.) to support new or existing systems used for or in support of GMP activities.
- Manage the Calibration Program in a cGMP facility, ensuring calibrations are performed as scheduled, and maintain documentation as required by Calibration Program SOPs
- Perform both hands-on calibration and manage outside contractors
- Responsible for maintenance, troubleshooting, calibration and repair on a variety of complex process and analytical instrumentation
- Schedule, supervise, and approve vendor calibrations
- Maintain calibration standards, instrument logs, and required documentation
- Develop and revise calibration procedures (SOPs)
- Develop, execute, summarize and review validation protocols (IQ/OQ/PQ).
- Assist in the resolution of deviations noted during protocol execution.
- Analyze and summarize Periodic Reviews of previously validated systems, and develop/implement protocols/changes based on outcome of the review.
- Maintain system and validation inventory lists through periodic reviews and approvals.
- Follow departmental and company-wide SOPs and policies and assist in the revision of procedures.
- Perform other miscellaneous duties as required
- Four-year technical degree or military training in a relevant technical program
- Minimum 2 years pharmaceutical/biotech calibration experience
- Familiarity with equipment qualification in a biotech/pharmaceutical environment.
- Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants.
- Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and willingness to learn and work within a team environment.
- Strong working knowledge of good documentation practices and cGMP requirements.
- Good interpersonal, organizational and trouble shooting skills.
- Ability to lift up to 40 pounds.
- Direct experience working in cleanrooms or sterile facilities is preferred, but not required.
- Ability and willingness to be regularly, predictably, and reliably at work
CoImmune, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.