Continuation Engineer - Cell Culture Company, LLC

Job Title:                                Continuation Engineer
Location:                                Minneapolis, MN
Immediate Supervisor:         Senior Director, Manufacturing
Travel Requirements:           0-10%
Education:                             B.S. or B.A. degree, minimum
Experience:                            3Years Related Experience
Status:                                    Full-Time
Compensation:                      Salaried/Exempt
CELL CULTURE COMPANY OVERVIEW
Cell Culture Company (C3) is a contract development and manufacturing organization (CDMO) focused on custom protein production for therapeutic and diagnostic industries. C3 also manufactures, distributes and services AcuSyst perfusion bioreactor systems.

Our advantage is our ability to deliver the highest levels of quality while reducing financial risk and increasing speed to market for our customers. Our employees are experts in cell culture, purification, and quality control. C3 has serviced 1,700 organizations globally.

Located in Minneapolis, Minnesota, C3 is headquartered at a 33,000-square foot facility that houses corporate offices, bioreactor manufacturing operations, a GMP-compliant custom mammalian and protein production space, and a distribution center.
GENERAL SUMMARY
C3 is currently recruiting for the position of Continuation Engineer, whose primary responsibility will be to support the manufacture of bioreactor instruments, disposables, and accessories. This role identifies and implements new and replacement parts to maintain current disposable and instrumentation product lines. Additionally, this role drafts and reviews complicated work instructions, drawings, and specifications with feedback from the manufacturing team. This team is tasked with meeting growth demands while maintaining stringent quality standards required through ISO 9001:2015.
Candidates must have experience meeting corporate goals related to production schedules, process optimization, cost control. This position will collaborate with the account services, supply chain, quality, engineering, and accounting departments to maintain sustainability of our products, resolve issues, and ensure on-time delivery of quality products to our customers.
DUTIES AND RESPONSIBILITIES

• Create and update manufacturing and safety procedures. Evaluate drawings, bill of materials, SOPs, and other documents when required to ensure they are accurate, clear, concise, and user-friendly.
• Work with quality control to ensure all manufactured products are within specifications.
• Work with the assemblers/technicians on the flow and function of the disposable and instrumentation manufacturing areas to enable high productivity and provide a safe working environment.
• Contribute with hands-on work to meet production schedules as needed.
• Prepare for and participate in customer and supplier audits.
• Participate in CAPA investigation and resolution process.
• Participate in new/replacement product design
• Facilitate the transition of new parts to production.
• Other duties as assigned

QUALIFICATIONS

• Strong leadership with excellent written and oral communication skills and the ability to maintain accurate documentation. Must have demonstrated ability to solve problems, think critically, make decisions, remain organized, multi-task, manage time, plan, and accomplish goals using interpersonal and organizational skills. Must be able to maintain a sense of urgency necessary to meet goals, objectives, and deadlines.
• Familiarity with RoHS, CE, ISO, FDA, and other relevant regulations and classifications.
• Experience manufacturing a complicated product line, preferably complex instrumentation and single-use disposables that are manufactured in a QSR, ISO, or similar environment.
• Demonstrated success in Lean Process Improvement.
• Ability to read and revise drawings/schematics/BOMs and review document change orders.
• Advanced ability to use computers to plan, execute, communicate, present, and analyze using Microsoft office suite and Solidworks
• Ability to maintain confidentiality at all times.

WORKING CONDITIONS

• Clean room and electronics manufacturing environment with routine tools, a variety of equipment, and custom fixtures.
• Office with accessibility to standard equipment, computer, copier, fax, and phone.
• Use of computer system requiring frequent mental and visual attention.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

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