Working in an FDA regulated clean room environment, this position is responsible for validation bioprocess equipment and GMP utilities.
Requires experience and a good understanding of the processes and equipment used in a GMP biopharma manufacturing facility.
Must have basic understanding of electrical and mechanical systems
Must have the ability to lift/carry 40 lbs. and work on ladders/step stools
Has demonstrated track record for executing (hands0on) validation activities in a GMP biopharma facility.
Has good working knowledge of the regulatory requirements (FDA, EMEA) for biopharma and equipment operations/processes and cleaning.
Must have experience in the operation/validation of autoclaves
Experience in other pressure rated systems such as fermenters is highly desirable
Must have basic mechanical maintenance/repair skills
Major Duties, Responsibilites & Communication:
Writes operational protocol(s), validation IQ, OQ, PQ protocols and SOPs for various equipment/systems in the facility
Reviews validation data, makes decisions/recommendations based on that data. Generates final summary reports.
Oversees the timely completion of all validation documentation, including coordination of contractor activities
Works closely with Manufacturing, QA/QC and Facilities staff in the execution of validation activities, as applicable
May interact with clients on equipment/process requirements
Works closely with various departments within our client and offers assistance, as needed
Measurement of Performance:
Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team.
Timeliness and accuracy in completion of projects and paperwork. (quantity of work)
Contributions to projects beyond general responsibilities. (quality of work)
Offers suggestions for correcting problems and for improving operations. (knowledge/problem solving)
Exercises good judgment in dealing with operational problems. (knowledge/problem solving)
Understanding of theory, rationale behind tasks performed (knowledge).
Demonstrated understanding and adherence to our client's policies, safety procedures and the cGMPs.
Ability to succeed in a team oriented environment under very dynamic (changing) conditions.
Education and Previous Experience:
B.S. in Engineering or other science
Minimum of 3 years’ experience in biopharma manufacturing
At least 2 years direct experience in the validation of fermenters and autoclaves
Experience with QC and Facilities Engineering is desirable