Process Engineer III/Senior, Upstream

About AGC Biologics  

AGC Biologics is a leading global biopharmaceutical Contract Development and Manufacturing Organization (CDMO) with a strong commitment to delivering the highest standard of service as we work side-by-side with our clients and partners, every step of the way. We provide world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), messenger RNA (mRNA), viral vectors, and genetically engineered cells. Our global network spans the U.S., Europe, and Asia, with cGMP-compliant facilities in Seattle, Washington; Boulder and Longmont, Colorado; Copenhagen, Denmark; Heidelberg, Germany; Milan, Italy; and Chiba, Japan. We currently employ more than 2,500 employees worldwide. Our commitment to continuous innovation fosters the technical creativity to solve our clients’ most complex challenges, including specialization in fast-track projects and rare diseases. AGC Biologics is the partner of choice. To learn more, visit www.agcbio.com.  

JOB SUMMARY

This position’s primary responsibilities are to support the Boulder, Colorado (BLD) manufacturing facility through technical assistance as it relates to manufacturing and process systems. The focus of the role is on ensuring manufacturing equipment, plant utilities and facilities are operating as intended to meet the requirements for biopharmaceutical manufacturing.

Specifically the role will provide tactical support of ongoing plant operations and strategic implementation of engineering projects to meet the changing needs of the business. Must be a SME in key critical engineering disciplines (Process, Electrical, Automation, Mechanical, HVAC, etc.) to support the startup, commissioning and lifecycle support of new and existing/legacy systems at the BLD manufacturing facility.

Applications being accepted through March 31, 2024

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsibilities

• System Owner of all process equipment for assigned functional areas.
• Liaison between MSAT, capital projects, automation and maintenance support groups in support of manufacturing.
• Develop / embed technical knowledge on Mammalian manufacturing equipment and processes in the EOS department.
• Mentor the development of a cross-functional engineering team (mechanical, electrical, automation)
• Manage resolution of major equipment breakdowns and quality issues in the suites by driving a robust root cause analysis (RCA) process.
• Provide SME support to Manufacturing and other departments for the design and operation of process equipment.
• Conduct troubleshooting and technical analyses on manufacturing equipment and processes.
• Assist with tech transfer of new Mammalian processes into the facility.
• Interact with the Reliability Engineer to strengthen the preventative maintenance program to eliminate equipment failure modes.
• Provide troubleshooting support to the Mammalian process systems.
• Implement new projects in the manufacturing area, while meeting all of the quality standards set forth by the company and government regulations.

KNOWLEDGE, SKILLS, AND ABILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• Adaptable; must be willing to remain flexible to accommodate changing business conditions, work requirements and scheduling needs in a rapidly changing environment.
• Demonstrated attention to detail with the ability to focus on the project or task at hand and consistently deliver error free results.
• Must be comfortable working in a fast paced environment and available to provide on-call support when needed.
• Excellent organizational skills with ability to multi-task and prioritize.
• Demonstrated proficiency with all Windows based programs, knowledgeable with any CMMS program.
• Excellent verbal and written communication skills; ability to communicate with multi-level audiences.
• Demonstrated ability to write investigations and Standard Operating Procedures (SOP’s).
• Demonstrated ability to develop and maintain clear and accurate documentation of process equipment or manufacturing processes.

EDUCATION and/or EXPERIENCE 

• BS/MS in Engineering (Chemical, Biotechnology, Mechanical, or Electrical) or Master highly preferable.
• Level III - Minimum of 5-7 years of relevant industry experience (Biotech / GMP manufacturing environment).
• Level Senior:  Minimum 8+ years of relevant industry experience (Biotech / GMP manufacturing environment
• Prior experience with Upstream unit operations (centrifugation, filtration, precipitation, bioreactors, CIP/SIP, mass flow technology, etc.)
• Minimum of 5 years of troubleshooting process automated systems in Biotech/Pharma Process.
• Experience with instrumentation and control with PCS, SCADA, DCS, Historian, MES systems preferred.
• Experience in the design and operation of Biopharmaceutical facilities, both manufacturing and support systems.
• Experience with single use manufacturing technology operations and troubleshooting.
• Experience leading technical teams.
• Experience writing reports for senior colleagues outlining new concepts, testing outcomes, and ongoing efficiency.
• Equivalent education and experience may substitute for stated requirements

COMPENSATION RANGE:

$83,920 - $148,610 annually based on experience and level 

Fluctuations in the job market may necessitate adjustments to pay ranges. Final pay determinations will depend on various factors, including, but not limited to experience levels, knowledge, skills, and abilities.

Benefits available to Team Members include subsidized insurance for the Team Member and designated dependents (medical, vision, dental, life and disability), eligibility to participate in the AGC Biologics 401(k) plan (including a generous matching contribution from the company and immediate vesting), vacation, sick time, and parental leave.

Team Members are also eligible to receive a discretionary annual bonus commensurate to the level of the role. The payout is based on both the company’s performance and the Team Member’s performance.

AGC Biologics offers a highly competitive compensation package and a friendly, collaborative culture that values personal initiative and professional achievement. AGC Biologics is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, color, family or medical care leave, gender identity or expression, genetic information, marital status, medical condition, national origin, physical or mental disability, political affiliation, protected veteran status, race, religion, sexual orientation, or any other characteristic protected by applicable laws, regulations and ordinance