Senior Process Engineer

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services, while treating candidates with the professionalism and respect they deserve.

• Duration: 8+ month contract

• Pay rate: $65-$75.96/hr

• Job Location: Emeryville, CA

• Schedule: Mon-Fri, 8am – 5pm (occasional after hours mfg support)

• Job#: bh15264

• The MS&T Process Engineering team is tasked with improving the maturity, scale, and efficiency of manufacturing processes; driving key initiatives that include capacity expansion, process scale-up and Tech Transfers activities.
• The Sr. Engineer will work with Scientists and Specialists within MS&T, partnering cross-functionally with Quality, Production and other engineering groups to develop processes for new products and sustain and improve processes for existing products within any one of the following Manufacturing areas: Fermentation, Purification, Bulk Fill or Technical Services.
• Initiate and lead process equipment improvements, onboarding and purchase of new equipment.
• Prepares equipment related operating procedures and/or relevant engineering documents (SOPs, protocols & reports for FATs, comparability, manufacturing process validation testing), including data interpretation and able to communicate technical results in cross-functional settings.
• Coordinating vendor visits for onsite service, work with instrumentation group for other calibration events.
• Participates in projects associated with process equipment, process improvements, as well as design, start-up, commissioning, and qualification of new investments.
• Leads technical support to commercial group for routine manufacturing processes Provides guidance to staff with production support activities including pre-production checks and equipment testing activities as required
• Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment/process related issues
• Provide technical support for new products to site including process/equipment feasibility assessments, process and equipment requirements
• Supports all QA Compliance investigations for process deviations, technical assessment of issues, root cause investigations, CAPA task management
• Ability to own and drive change control records as required to support departmental projects and assigned CAPAs.
• Ability to lead process technology transfers from other depts. to increase the effectiveness of Manufacturing processes Partners and collaborates with site Project Management organization as required with higher-level, long-term initiatives

• Strong technical expertise in biotech unit operations and equipment, especially in the area of recombinant protein production and protein purification
• Advanced working knowledge and experience in cGMP environments (understanding of equipment, technology, and quality systems requirements)
• Experience with project design, construction, start-up, commissioning and validation as well as leading and supporting factory acceptance tests and site acceptance
• Experience with automated equipment engineering and validation
• May be required to work periodically out of normal business hours
• Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment.
• Must be able to work independently, manage multiple priorities, with the ability to prioritize and complete activities on time
• Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.
• Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.
• 5S, OpEx, and Lean manufacturing experience a plus

• BS in Biochemical, Chemical or Mechanical Engineering and 8 years' experience (Masters with 4+ years') in a pharmaceutical / biotech / vaccine operations and validation principles, with thorough working knowledge of production unit operations.