Process/Manufacturing Senior Manager, Engineering

RepliGen CorporationRancho Dominguez, CA, CA
$180,000 - $225,000Onsite

About The Position

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.

Requirements

  • Bachelor's degree in Engineering or a related technical discipline required.
  • 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.

Nice To Haves

  • Advanced degree (MS, MBA, or equivalent) preferred.
  • Experience supporting filtration, single-use technologies, medical devices, or related manufacturing processes is preferred.

Responsibilities

  • 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.

Benefits

  • paid time off
  • health/dental/vision
  • retirement benefits
  • flexible spending accounts
  • variable cash programs (bonus or commission)
  • equity as part of the compensation package
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