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.
Title: Senior Process Engineer
Hiring Organization: Connexion Systems & Engineering
Compensation, Benefits, and Employment Type
- Duration – Contract – 6 months+
- Pay rate: $70-73hr.
- Job Location: Emeryville, CA
- Job#: bh12973
Senior Process Engineer
- The 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 activities, site transfers, and critical pieces of new product introductions.
- 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 and investigation studies. Coordinating vendor visits for onsite service, work with instrumentation group for other calibration events.
- Leads technical support to commercial manufacturing group for routine manufacturing processes
- Evaluates new technology and implements new process equipment into GMP manufacturing
- Provides guidance to staff with production support activities including pre-production checks and equipment testing activities as required
- Design and execute system/equipment-based studies to screen, optimize, and scale production processes, analyzes and interprets results, participates in process improvement, development, scale up and qualification activities.
- Ability to troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem-solving techniques and quality assurance mechanisms when appropriate
- Work closely with process characterization teams to assure process reliability and robustness in preparation for comparability and process validation.
- 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.
- 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 for the department as required to support departmental projects and assigned CAPAs.
- Participates in projects associated with process equipment, process improvements, as well as design, start-up, commissioning, and qualification of new investments.
- 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
- Ensure successful manufacturing process comparability and process validation runs by assessing risk, setting preventative measures in place, investigating, and troubleshooting equipment/process related issues
- Strong technical expertise in biotech unit operations and equipment, especially in the area of 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
Skills and Experience:
CORRECTIVE AND PREVENTIVE ACTION
Please use the apply buttonto submit your resume for consideration. A Connexion Representative will contact you immediately.
When responding to this job posting you MUST include the Job# and Job Title in your subject line.
If you are active in a job search but this job is not for you, please reach out to
firstname.lastname@example.org. We would be glad to help you find the perfect job!