We're looking for a Process Associate II, working in the Pharmaceuticals & Medical Products industry in Exton, Pennsylvania, United States.
Provides direct support in the control and preparation of large scale media/buffer solutions utilizing disposable mixing technology, raw material sampling and submission, and preparation/sterilization of process equipment using a GMP Parts washer and autoclave.
Provides manufacturing expertise for functions supporting the manufacture of preclinical, Phase I and Phase II clinical trial materials within a cGMP Biologics Pilot Plant, including assisting in the transfer of new technologies/processes, operation, and troubleshooting of equipment, preparation, and close-out of documentation, and ensuring compliance to relevant regulations.
Provides assistance with the development and qualification of washer cycles, load pattern configurations and sterilization packaging techniques.
Supports change control and (re) qualification related testing for all equipment/systems, and supports validation protocol development (IQ, OQ, PQ), execution, assessments, data reviewing specifications, procedures, protocols and final reports preparation.
Supports the supply chain logistics including oversight of material movements external and internal to the facility working closely with Warehouse staff.
The pay range we're offering is 40 to 45 per hour. This position may present an opportunity to go permanent.
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 degree in Biological/Chemical/Physical Sciences, or Engineering is a must
3-5 years in a multi-discipline cGMP environment, commissioning and operating equipment in Support production areas
1-2 years experience in SAP at a pharmaceutical or bio-technology company preferred.
Proficient in the operation of all area specific production equipment such as washer, autoclave, and disposable mixing technology for media and buffer solutions
Willing to work in any shift supporting 24/7 bulk operations that may include weekends, holidays and overtime, as required
Ability to sit and/or stand for extended periods of time and ability to lift 25 lbs
Self-starter with a strong focus on detail, safety, quality and results
Ability to multi-task and adjust to varying priorities to meet timelines
Ability to identify, investigate, and trouble-shoot basic process and equipment problems
Working knowledge of cGMP, EMEA, and JP regulations
Good written and communication skills
Good problem solving and interpersonal skills with the ability to work in a 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.