Job Type

full-time

posted

8 days ago

Location

Emeryville, CA

Description

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
Duties:

  • 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

    Skills:
  • 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


Education:

  • 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:
Required Skills:
CAPA
CHANGE CONTROL
DETAIL-ORIENTED
ENGINEER
FEASIBILITY
Additional Skills:
FERMENTATION
LEAN MANUFACTURING
MANUFACTURING PROCESS
MANUFACTURING PROCESSES
OPERATIONS
OPEX
ORGANIZATIONAL SKILLS
PROBLEM SOLVING
PROCESS ENGINEER
PROCESS IMPROVEMENT
PROCESS IMPROVEMENTS
PROCESS VALIDATION
PROJECT DESIGN
PROJECT MANAGEMENT
PURIFICATION
QA
QUALITY ASSURANCE
SOPS
TECHNICAL SERVICES
TECHNICAL SUPPORT
VALIDATION TESTING
AUTOMATED EQUIPMENT
BIOCHEMICAL
CALIBRATION
CGMP
CORRECTIVE AND PREVENTIVE ACTION
GMP
INSTRUMENTATION
MECHANICAL ENGINEERING
PROCESS ENGINEERING
PROTEIN PURIFICATION
 

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About the Company

Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering
Company Logo Connexion Systems & Engineering

Connexion Systems & Engineering

Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity.  Over the last 20 years Connexion has built the most admired team of staffing experts in the industry.  We give back, change lives and offer unconditional support to the candidates we represent.

Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.

Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want

Company Size

500 to 999 employees

Industry

Staffing/Employment Agencies

Founded

1999

Website

https://www.csetalent.com/