Pharmaceutical Development/Technical Operations Sr Process Engineer - Rancho Dominguez, CA Rancho Dominguez, California
Orbis Clinical is seeking a Sr Process Engineer located in Rancho Dominguez, CA for 12 months.
Job Title: Sr Process Engineer
Location: Rancho Dominguez, CA
Contract: 12 months
Description:
We are seeking a highly motivated and experienced Senior Engineer to lead multi-product project execution, technology transfer, and manufacturing support efforts at our Rancho Dominguez facility. This contract role requires close collaboration within our global engineering network to deliver strategic initiatives.
The ideal candidate has a strong background in medical device manufacturing, process engineering, and process validation, preferably within GMP, ISO 9001, or ISO 13485 environments. Success in this role requires technical proficiency, a collaborative mindset, and the ability to drive projects with minimal oversight.
Responsibilities:
- Lead projects in tech transfer, process development, process validation, and line improvements.
- Partner with global engineering teams to support the transfer of manufacturing equipment and processes to contract manufacturing sites
- Support process development activities at contract manufacturing sites.
- Define and execute process, material, and equipment qualifications
- Author and maintain engineering documentation including user requirement specification (URS), drawings, test protocols, change controls, and technical reports.
- Spearhead the review and harmonization of existing manufacturing process documentation
- Act as a Subject Matter Expert for filtration and other bioprocessing manufacturing systems.
- Identify and implement process improvements, ensuring compliance with industry standards and regulations.
- Mentor junior team members and support standardization and training of best practices.
- Apply statistical tools to support validation and process optimization efforts.
- Drive innovation in filtration systems and related support infrastructure to enhance performance and scalability.
Education and/or Work Experience:
- Bachelor’s degree in Engineering required.
- 7–10 years of experience in medical devices or similar fields.
- Hands-on experience with:
- Process validation and equipment qualification
- Tech transfer between international sites
- Data analysis and automation
- Filtration systems (Hollow Fiber, Flat Sheet Membranes)
- Strong knowledge of ISO 9001, ISO 13485, or GMP manufacturing standards.
- Proficient in SolidWorks/CAD, MS Office, and electronic file management systems.
- Familiarity with single-use systems, sterilization techniques, and lean manufacturing principles preferred.
- Demonstrated ability to lead cross-functional teams and manage projects in a matrixed organization.
- High level of personal integrity, adaptability, and leadership by example.
Other requirements:
- Capable of independently defining and executing projects.
- Provides technical direction and feedback to teams across disciplines.
- Balances day-to-day plant support (20%) with project execution (80%).
- Communicates clearly with senior leadership on project scope, risks, and progress.
- Delegates tasks effectively and contributes to team development.
Physical Requirements:
- Regular work in cleanroom and laboratory environments.
- Exposure to chemicals, mechanical systems, and occasional electrical hazards.
- May be required to lift up to 50 lbs and operate in areas with noise and vibration.
Must Have
- Manufacturing Transfers
- Process Development (PD)
Nice To Have
- Tangential Flow Filtration (TFF)
Compensation Details:
- Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.
- The Pay Range for this position is $64.51 – $108.96 per hour, can vary depending on employment status.
- Orbis Clinical provides W2 Employees with options for Health Benefits and 401K.
EEO and Reasonable Accommodation Statement:
Epic Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.
By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.
