We're looking for a Senior Principal Process Associate, Support Operations, working in the Pharmaceuticals & Medical Products industry in Exton, Pennsylvania, United States.
Provides hands-on support and/or some leadership in the operation of equipment to support pre-clinical, phase I and phase II clinical trials.
Coordinates equipment maintenance, calibration, and validation with appropriate internal departments.
Provides support and/or some coordination effort for the transfer of new processes and technologies for media, buffer and excipient preparation working with R&D and the technology transfer laboratory personnel.
Supports process performance monitoring, operational excellence activities, and process improvement strategies.
Leads in the qualification/validation program for pilot plant equipment/systems by supporting all commissioning, initial testing, re-qualification, and validation maintenance activities.
We're offering Competitive Compensation and Benefits.
Our client is an award-winning clinical development company. Improving lives globally with 20+ years’ experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.
Experience Required for Your Success
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.
What Do You Think?
Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.