Ref No.: 18-03500
Location: Vacaville, California
Job Title: Process Engineer
Job Company: Major BioPharma
Job Location: Vacaville, CA
Job Duration: 6+ mos contract; Replacement

Job Description:

The Process Engineer I will provide representation and leadership for the in the delivery of large capital projects for manufacturing-related facilities. This is a significant position associated with the ultimate delivery of products and pipeline processes for a product portfolio.

The qualified candidate will be versed in working with multi-discipline engineering capital project teams, as well as other project related cross-functional teams with representatives from multiple departments. As such, the Process Engineer I is accountable for process and equipment design, engineering document development, reviews and/or approvals through the project phases of planning, design, procurement, construction, commissioning, and equipment/system qualification for Good Manufacturing Procedures and development facilities.

The focus will be on process, systems and equipment associated with bulk biochemical operations (e.g. purification, recovery, harvest, CIP/SIP, and buffer prep/ buffer hold). This position requires the successful candidate to coordinate and direct contract resources. Field supervision, equipment inspection and start-up, trade coordination, and training are also required. Success in these areas will depend upon the individual's ability to effectively lead, collaborate and communicate with team members, and manage project scope, budget and schedule as it relates to the process engineering discipline.
  • Monitor, analyze, troubleshoot, and contribute to the establishment and maintenance of the validated state of cdownstream processing in CCP2.
  • Contribute to the design, formulation, review, and implementation of downstream manufacturing formulae (automation recipes, Tickets), SOPs, and associated process documentation.
  • Under the guidance of more senior staff, provide technical support for discrepancies and investigations, product impact assessments to support investigations and changes, inspections, CAPAs, plus other quality commitments.
Desired Skills:
  • The Process Engineer I is responsible for improvements in the efficiency and effectiveness of the Manufacturing Sciences department by contributing to departmental infrastructure (guidelines, procedures, practices, standards) either through individual contribution, or leadership of a team (departmental or cross-functional).
  • Strong technical writing, verbal communication, interpersonal and problem solving skills. Ability to work independently, organize and lead small to mid-scale projects. On-call support for Manufacturing is required with this position.
Experience:
Approximately 4 years direct manufacturing sciences experience with increasing levels of responsibility for a wide range of projects including large scale biochemical manufacturing, utility and automation systems. Must have proven knowledge of Current Good Manufacturing Procedures compliance. The position requires strong leadership, collaboration, communications, prioritization, and problem solving skills.

Education:
BA/BS in life/physical sciences, engineering, or equivalent experience.