Sr. Principal Process Associate - cGMP (Onsite -Direct Hire $80K)
Lenmar Consulting Inc.Full time Full day
BS or MS in Biological Sciences, Engineering or equivalent job experience/degree is strongly preferred.
Minimum of 7-10 years progressive experience in a multi-discipline cGMP manufacturing environment, running processes and equipment in Support production areas.
Proficient in weigh, dispense, and sampling procedures for controlled raw materials
Proficient in the operation of all area specific production equipment such as washers, autoclaves, and disposable mixing technology for media and buffer solutions.
Knowledgeable in technology transfer, equipment validation and facility startup.
Ability to identify, investigate, and resolve basic process and equipment problems.
Strong working knowledge of international (21CFR, EMEA, and JP) cGMP regulations.
Must be willing to work any shift in supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required.
Must be able to sit and/or stand for extended periods of time and be able to lift 25 lbs.
Self starter with a strong focus on detail, safety, quality and results.
Strong written and verbal communication skills.
Good problem solving and interpersonal skills with the ability to work and lead others in a small team environment required.
All your information will be kept confidential according to EEO guidelines.