Process Engineer II
4625 NW Brookwood Pkwy, Builiding 1, HBO01 Hillsboro, CA 97124
Bayside Solutions is seeking a Process Engineer II to be part of our client’ s team in Hillsboro. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Process Engineer II
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- A new product is being transferred to Hillsboro Technical Operations (HTO) Liquid Fill Line 1. This role will enable this transfer, a new 15cc container closure format will be introduced to the Filling Line in support of timely execution of tech transfer activities.
- The Process Engineer will provide support to a Tech Transfer Project, as well as the MSAT Process Engineering Department, specifically accountable for supporting process development and equipment/system qualification activities.
- The focus will be on systems and equipment associated with Drug Product operations (e.g. formulation, vial handling/filling, CIP/SIP).
- Success in these areas will depend upon the individual' s ability to effectively lead, collaborate and communicate with team members.
- Cycle Development and Performance Qualification of DP Process Equipment, including but not limited to:
- CIP/SIP Skid.
- Vial Washing Machine.
- Vial Depyrogenation Tunnel.
- Vial Filling Machine and Time/Pressure Filling System.
- Filling Isolator.
- Vial Capping Machine.
- Formulation Tanks.
- Development, Review and Approval of Cycle Development and Validation Protocols.
- Planning and execution of studies/protocols on the manufacturing systems, including coordination with supporting departments to ensure material and resource availability.
- Complete end to end process of any discrepancies or deviations resulting from executed protocols.
- Development and post-approval of necessary Summary Reports.
- Create and manage Change Records in Trackwise to support project execution.
- Participate in Risk Assessment activities and support Root Cause Evaluation for deviations.
- Support product-specific process and recipe development activities, including characterization and engineering runs.
Summary of Qualifications:
- BS/MS in Chemical or Mechanical Engineering.
- Minimum of 3-5 years bio/pharmaceutical Drug Product process development and project execution experience, with proven knowledge of Current Good Manufacturing Procedures compliance.
- The position requires strong leadership, collaboration, communications, prioritization, and problem solving skills.
- The Process Engineer will provide technical knowledge and support to other Process Engineers in support of Tech Transfer activities.
- Candidate must have a demonstrated record of competencies that match the proposed activities.
- Flexibility to work nights and weekend support will be required during project execution windows.
- Skills include needed:
- Teamwork & Collaboration.
- Technical Knowledge with experience in Drug Product Manufacturing (ideally liquid vial filling).
- Good Communication (Verbal and Written).
- Technical Writing proficiency.
- Self-starter, able to execute work with limited direction.
- Flexibility to support nights and weekend work during key project execution windows.