Process/Manufacturing Senior Manager, Engineering

Posted Yesterday
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Rancho Dominguez, CA, USA
In-Office
180K-225K Annually
Senior level
Biotech
The Role
Lead and mentor a multidisciplinary process and manufacturing engineering team to drive safety, quality, validation, process optimization, technology transfers, and capital projects. Support new product introductions, regulatory compliance (ISO/GMP), operational excellence (Lean/Six Sigma), and cross-functional collaboration to expand capacity and improve yield, productivity, and cost performance.
Summary Generated by Built In
The Senior Manager, Process & Manufacturing Engineering provides strategic and technical leadership for manufacturing engineering, process engineering, technology transfer, and capital project execution at the Rancho Dominguez facility. This role leads a multidisciplinary engineering team responsible for manufacturing support, process optimization, new product introductions, equipment and process validation, and operational excellence initiatives.
Working closely with Operations, Quality, Supply Chain, R&D, Facilities, EHS, and the Global Engineering Network, the Senior Manager drives safety, quality, compliance, productivity, and capacity expansion while supporting the company's growth objectives.
  • Lead, develop, and mentor the Process and Manufacturing Engineering team, fostering a culture of safety, accountability, collaboration, and continuous improvement.
  • Provide technical leadership for manufacturing processes, equipment, and systems supporting filtration and single-use product manufacturing.
  • Drive manufacturing performance through process optimization, troubleshooting, root cause analysis, yield improvement, cost reduction, and operational excellence initiatives.
  • Lead the implementation of new products, technology transfers, process validations, and lifecycle management activities.
  • Manage capital projects, equipment installations, facility modifications, and capacity expansion initiatives from concept through implementation.
  • Partner with Operations, Quality, Supply Chain, Facilities, and R&D to support manufacturing performance and strategic business objectives.
  • Ensure compliance with applicable regulatory, quality, and company standards, including ISO 9001, GMP, validation, and change management requirements.
  • Serve as the engineering representative during customer audits, regulatory inspections, and quality audits.
  • Develop and approve engineering documentation including change controls, protocols, risk assessments, investigations, and technical reports.
  • Utilize data analytics, Lean Manufacturing, Six Sigma, and statistical methods to improve process capability, OEE, quality, and productivity.
  • Manage departmental budgets, capital plans, staffing, and resource allocation to support business priorities.
  • Collaborate with the Global Engineering Network to standardize best practices and execute strategic growth initiatives.

Qualifications

Education

  • Bachelor's degree in Engineering or a related technical discipline required.
  • Advanced degree (MS, MBA, or equivalent) preferred.

Experience

  • 10+ years of engineering experience including 5 years of leadership within life sciences, biopharmaceutical, medical device, biotechnology, or advanced manufacturing environments.
  • Proven success leading manufacturing, process engineering, technology transfer, operational excellence, and capital project initiatives within regulated industries.
  • Experience managing and developing technical teams while driving business performance, operational efficiency, and organizational growth.
  • Strong understanding of manufacturing operations, quality systems, validation, and regulatory requirements, including ISO and/or GMP environments.
  • Experience supporting filtration, single-use technologies, medical devices, or related manufacturing processes is preferred.

Leadership & Professional Competencies

  • Demonstrated ability to lead high-performing teams and influence across cross-functional and global organizations.
  • Strategic thinker with strong business acumen and the ability to translate organizational objectives into executable engineering strategies.
  • Proven track record of driving operational excellence, continuous improvement, and organizational change.
  • Strong communication, stakeholder management, and decision-making skills, with the ability to effectively engage employees, customers, and senior leadership.
  • Ability to balance day-to-day operational priorities with long-term growth, capacity, and technology strategies

Our mission is to inspire advances in bioprocessing as a trusted partner in the production of biologic drugs that improve human health worldwide. Focused on cost and process efficiencies, we deliver innovative technologies and solutions that help set new standards in bioprocessing. The estimated salary range for this role, based in the United States of America is $180,000-$225,000. Compensation decisions are dependent on several factors including, but not limited to an individual's qualifications, location, internal equity, and alignment with market data. Additionally, employees are eligible to participate in one of our variable cash programs (bonus or commission) and eligible roles may receive equity as part of the compensation package. We offer a wide range of benefits such as paid time off, health/dental/vision, retirement benefits and flexible spending accounts. All compensation and benefits information will be confirmed in writing at the time of offer.

Skills Required

  • Bachelor's degree in Engineering or related technical discipline
  • 10+ years of engineering experience including 5 years of leadership within life sciences, biopharmaceutical, medical device, biotechnology, or advanced manufacturing
  • Proven experience leading manufacturing, process engineering, technology transfer, operational excellence, and capital project initiatives in regulated industries
  • Strong understanding of manufacturing operations, quality systems, validation, and regulatory requirements, including ISO and/or GMP environments
  • Experience managing and developing technical teams and departmental budgets/capital plans
  • Experience utilizing Lean Manufacturing, Six Sigma, data analytics, and statistical methods
  • Experience supporting filtration and single-use technologies or related manufacturing processes
  • Advanced degree (MS, MBA, or equivalent)
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The Company
HQ: Waltham, MA
1,220 Employees

What We Do

FRAUD ALERT: Please take note that it has come to our attention that individuals purporting to work for Repligen are reaching out to prospective job applicants using fraudulent email addresses. All legitimate communications from Repligen will be sent from an individual with an email address ending in @repligen.com. If you have any concerns that a communication may be fraudulent and you would like to confirm whether it is, you may email [email protected] and someone will respond. Repligen is a bioprocessing-focused life sciences company bringing over 40 years of expertise and innovation to our customers. We are inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions that address critical steps in the production of biologic drugs, principally monoclonal antibodies. Repligen headquarters is in Waltham, Massachusetts and our manufacturing facilities are located around the world. We market our products globally through a direct commercial organization in the U.S., Europe and Asia, as well as through strategic partners in select markets.

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