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Head of Project Engineering

Scientific Protein Laboratories

Waunakee, WIOnsitePosted 5 days ago
Full TimeDirector & AboveManufacturing & CMCPharmaceutical
Original posting ↗

Summary

This position manages the activities of the Engineering team at the SPL Waunakee site. Provide technical guidance on projects and process scale-up activities. Provide management oversight and guidance to project engineers on capital projects from initiation through start-up and closure documentation, ensuring internal policies and procedures are followed.

Job description

Responsibilities

  • Lead, develop, and prioritize the work of the Project Engineering team, assigning projects across engineering team based on workload, site priority, and project requirements.
  • Build and develop the engineering team: Mentor engineers, grow technical capability, define development paths, and lead succession planning.
  • Own the capital project portfolio: Intake, prioritization, scheduling, and resource balancing across the engineering team.
  • Support site capital planning and develop the long-range engineering roadmap in coordination with the Director and site leadership.
  • Own project budgets and capital appropriation: Develop capital appropriation requests, forecast and control project costs, and report project financial performance to site leadership.
  • Directly manage and execute selected capital projects as a working leader to maintain project throughput.
  • Lead the commissioning, qualification, and validation (CQV) lifecycle for capital projects, including URS, design qualification, FAT/SAT, and IQ/OQ/PQ.
  • Manage the development, tracking, and delivery of system turnover packages.
  • Manage external engineering firms, equipment vendors, and construction contractors.
  • Establish and enforce consistent project governance, engineering standards, documentation, and stage-gate / design-review discipline.
  • Develop and maintain engineering design standards, equipment and instrumentation specifications, and design basis documentation.
  • Cross-functional interface with Manufacturing, Quality, EHS, Automation & Electrical Maintenance Engineering, Reliability & Compliance, CSV, and key customer programs.
  • Partner with Manufacturing and Quality to align engineering project scope, timing, and change control with production and compliance needs.
  • Own the site's engineering drafting and drawing management function, including CAD standards and revision control.
  • Ensure engineering drawings (P&IDs, facility and equipment layouts, electrical, and mechanical drawings) are accurate and current.
  • Identify and lead continuous improvement and operational efficiency projects.

Additional Responsibilities

  • Serve as the primary engineering interface for customer-driven capital and process projects.
  • Work with Quality Systems group to manage Change Control Program.
  • Implement metrics necessary to monitor the effectiveness and continual improvement of the assigned functions.
  • Support off work hour emergency situations related to incidents that compromise facility preparedness.

Required Qualifications

  • Bachelor of Science Degree in Engineering or related scientific discipline.
  • 10+ years of engineering experience in a chemical or pharmaceutical production environment or equivalent.

Preferred Qualifications

  • Chemical or Mechanical Engineering degree preferred.
  • Advanced degree in a Scientific discipline or other technical area.
  • 5+ years of experience working in a regulated environment, including ISO, cGMP, and OSHA 1910.119 (PSM).
  • 3+ years of experience managing capital projects.

Requirements

  • Bachelor of Science Degree in Engineering or related scientific discipline
  • 10+ years of engineering experience in a chemical or pharmaceutical production environment or equivalent
  • Chemical or Mechanical Engineering degree preferred
  • Advanced degree in a Scientific discipline or other technical area
  • 5+ years of experience working in a regulated environment, including ISO, cGMP, and OSHA 1910.119 (PSM)
  • 3+ years of experience managing capital projects

Benefits

  • Medical, Dental & Vision
  • Life & AD&D Insurance
  • Short & Long-term Disability
  • Health & Flexible Saving Accounts
  • Employee Assistance Program
  • Generous Vacation
  • Paid Holidays
  • 401(k)
  • Advancement Opportunities

Company overview

Scientific Protein Laboratories (SPL) is a leading global supplier of high-quality active pharmaceutical ingredients (APIs) with over four decades of experience in the pharmaceutical manufacturing industry. Founded in 1976 in Waunakee, Wisconsin, the company specializes in cGMP biopharmaceutical manufacturing and is among the largest commercial suppliers of Heparin Sodium USP, Pancreatin USP, and Pancrelipase USP. SPL serves pharmaceutical, veterinary, and food industries worldwide, operating manufacturing facilities in both Waunakee, Wisconsin and Sioux City, Iowa. The company focuses on extracting, isolating, and purifying naturally-derived materials from animal and plant sources, with particular expertise in porcine-sourced starting materials. As a subsidiary of Shenzhen Hepalink Pharmaceutical since 2014, SPL maintains a strong commitment to regulatory compliance and quality assurance, operating strictly in accordance with FDA's cGMP requirements while providing comprehensive regulatory support to its global customer base.

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