- Posted: over a month ago
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, employing a global team of skilled professional and experts that span across strategically located offices in the United States, Europe, Asia, and the Middle East. PSC operates in 52 countries globally and has served thousands of clients to date.
We focus on providing quality consulting services to ensure our client’s success. PSC provides cost-effective solutions, while providing exceptional technical capabilities and customer service to our clients for all projects ranging from supplier quality audits to greenfield projects. We understand that the world of life science is evolving rapidly, and we must continue to offer new products and services to meet our customer’s expectations.
We are hiring a mid to senior level Process Engineer to support activities related to design and installation of new facility, manufacturing process, cleaning process, equipment, critical utilities, and computerized systems.
- Responsible for the delivery of engineering services from conceptual design through construction of various systems used to manufacturing raw material for cGMP use.
- Review, revise, and execute specification documentation (URS, FDS, DS, SDS).
- Serve as the Engineering SME for facility/equipment/process projects, performing activities associated with the design and qualification of the new and existing equipment used in a manufacturing plant. Equipment may include batch processing tanks, reactors, filter dryers, HPLCs, filtration system, lyophilizers, cold rooms, ultra-low freezers, HVAC, and purified water.
- Support the Engineering Director on capital projects for facility remodeling and expansion.
- Provide strong knowledge in design of gas and liquid utility system extensions, including N2, CDA, flammable solvent distribution, and purified water.
- Update drawings and P&ID to reflect changes to existing processes
- Manage and support the development and execution of FATs, SATs, DQ, IQ, OQ, PQ, and other relevant life cycle documents leveraged to support validation effort.
- Execute protocols as needed.
- Draft of new procedures, SOP’s and protocols as well as training of staff for these expectations
- BS degree in Mechanical, Electrical, Chemical, Manufacturing Engineering or a Science related field
- 4+ years of experience in engineering within a pharmaceutical manufacturing operation
- Experience working on engineering design processes.
- Familiar with applicable domestic and international GMP regulations (e.g. 21 CFR 210).
- Excellent written and oral communication skills
- Must be knowledgeable in design of gas and liquid utility system extensions, including N2, CDA, flammable solvent distribution, and purified water.
- Ability to provide Project Management support as needed, including leading team meetings, taking meeting minutes, maintaining schedule and budget, managing vendors, etc. (preferred).
- AutoCAD experience is a plus.
- P&ID experience is required.
- Project management experience with construction companies is required.
Offering a full suite of benefits, PSC Biotech™ is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
- 401(k) and 401(k) matching - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Discounted rate at 24 Hour Fitness
- Financial Perks and Discounts
ManufacturingView all jobs at PSC Biotech