Process Engineer - PSC Biotech
Los Angeles, CA 0000
About the Job
Your Role
We are currently seeking a Process Engineer with a background in pharmaceutical/biotech supporting the development of downstream process equipment operations.
You will work within a team of engineers and work closely with a cross-functional team and coordinate activities between Manufacturing, Quality and Validation. Working as part of a project team, you will be required to carry out the development process engineering including creation of documentation.
Responsibilities:
- Execute activities and protocols required for separation unit operation development.
- Drafting, finalization and approvals of protocols and final reports.
- SOP drafting, finalization, and approval.
- Troubleshoot and provide resolution to technical issues to support ramp-up and operations of equipment and facilities.
- Ability to interface with other departments to resolve issues related to equipment, process, and compliance.
- Complete relevant paperwork following GDP/GMP guidelines.
- Support process team projects and Continuous Improvement efforts.
- Share process knowledge with colleagues across shift.
- Manage sample coordination with Quality Control.
- Conduct Data analysis and analytical testing.
- Complete material assessments and meet/interface with external vendors (e.g., equipment suppliers).
Requirements
Bachelor’s degree in engineering or related field.
3 years or more of experience in a regulated industry, including automation, processes, and facilities.
Knowledge of technical validation and system documentation.
Experience working in a GMP environment.
Experience working in a cleanroom or laboratory environment preferred.
Highly motivated and flexible, and adaptable to a fast-paced and changing environment, requiring effective interpersonal and teamwork skills.
This position is 60%-80% onsite (hybrid).
Benefits
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.
PTO, Sick Time, and Paid Holiday.
Education Assistance.
Pet Insurance.
Discounted Fitness/Gym Rates.
Financial Perks and Discounts.