Sr Manager Process Engineering Bulk Drug Sub - Holly Springs, NC

Senior Manager Process Engineering Downstream

Location:

Holly Springs, North Carolina. This is an on‑site position with a requirement of approximately 10% domestic/international travel.

• Lead the engineering team, manage technical projects, and drive innovation in product design and manufacturing processes.
• Oversee the commissioning, qualification, and start‑up of process equipment in alignment with GMP requirements and global engineering standards.
• Ensure equipment and systems are installed, operated safely, and comply with environmental, health, and safety practices and regulations.
• Perform engineering assessments for plant equipment operations, implement equipment modifications, and support engineering runs for new product or technology introductions.
• Provide system ownership for downstream purification equipment and CIP/SIP skids used in biologics manufacturing.
• Lead a team of Process Engineering professionals, serve as the main point of contact for the Process and Equipment Engineering function, and establish clear expectations and priorities.
• Encourage a culture of continuous improvement, partnership, and knowledge sharing; provide development opportunities, feedback, and actively listen to staff.
• Collaborate with key stakeholders such as Manufacturing, Quality, Process Development, Maintenance, and network partners.
• Work with original equipment manufacturers and integrated service providers for breakdown and planned maintenance of process equipment.
• Identify and implement engineering‑based improvements or upgrades to process equipment systems, including developing business cases and translating requirements into design specifications.
• Develop equipment maintenance programs, ensure availability of spare parts, and coordinate maintenance activities.
• Ensure plant readiness and compliance for internal audits, external agency audits, and partner audits for the process equipment.
• Identify performance risks, advise on risk reduction strategies, and provide technical support to troubleshoot and resolve process and system issues.
• Provide strategic, tactical management, and leadership to ensure 24/7 day‑to‑day reliability of plant operations.
• Participate in the budgeting process for process engineering, including forecasting costs, managing expenditures, and ensuring efficient allocation of resources.

• High school diploma / GED and 12 years of engineering experience, or
  Associate’s degree and 10 years of engineering experience, or
  Bachelor’s degree and 8 years of engineering experience, or
  Master’s degree and 6 years of engineering experience, or
  Doctorate degree and 2 years of engineering experience.
• Minimum of 2 years of direct people management or leadership experience leading teams, projects, or programs, concurrently with the required technical experience.

• Bachelor’s degree in Chemical, Mechanical, or related engineering field.
• 8+ years of relevant work experience with 5+ years in biopharmaceutical operations/manufacturing focused on process and plant engineering.
• Demonstrated people management and leadership experience.
• Direct knowledge of biopharmaceutical production facility with downstream purification and CIP/SIP skids.
• Experience with tech transfer, process design, and commissioning & qualification.
• Experience working in a regulated environment (cGMP, OSHA, EPA, etc.) and familiarity with GMP quality systems including change control, non‑conformances, corrective & preventative actions, and validations.
• Familiarity with designing and operating equipment used in biopharmaceutical manufacturing.
• Strong communication, facilitation, and teamwork skills.
• Strong leadership, technical writing, and presentation skills.
• Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
• Work schedule flexibility required to support 24/7 operations, including occasional after‑hours coverage.

Salary range: $75,000 – $100,000. Benefits and additional compensation may be provided at the company's discretion.

This position is open to all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, or veteran status.