Head of Project Engineering

Join our team at Scientific Protein Laboratories (SPL), a world leader in biosourced pharmaceuticals, located just outside of Madison, Wisconsin in Waunakee!  SPL is an innovative biopharmaceutical leader with unique products and services supporting the pharmaceutical industry globally.  For over 40 years, SPL specializes in the development and cGMP compliant manufacturing of Active Pharmaceutical Ingredients (APIs).  SPL has an exciting opportunity to join the team as the Head of Project Engineering.

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.  Perform duties at an elevated degree of professionalism, independence, and sense of ownership.

Responsibilities include :

- 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 to strengthen the site’s long-term engineering bench.

- 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 user requirement specifications (URS), design qualification, factory and site acceptance testing (FAT/SAT), and IQ/OQ/PQ, in coordination with Quality and Validation to deliver new and modified systems in a qualified, GMP-compliant state.

- Manage the development, tracking, and delivery of system turnover packages, ensuring a clean and well-documented handover of completed systems and equipment to Manufacturing and Maintenance.

- Manage external engineering firms, equipment vendors, and construction contractors, including scope definition, bid evaluation, and oversight of design, fabrication, installation, and construction performance.

- Establish and enforce consistent project governance, engineering standards, documentation, and stage-gate / design-review discipline across all projects.

- Develop and maintain engineering design standards, equipment and instrumentation specifications, and design basis documentation so that current, accurate technical information is available to support projects, operations, and audits.

- 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.

- Coordinate with the Automation & Electrical Maintenance Engineering, Reliability & Compliance, and CSV functions so projects are delivered with proper automation, reliability, and validation integration.

- Own the site’s engineering drafting and drawing management function: Establish and maintain drafting and CAD standards, drawing numbering conventions, and revision-control practices to ensure consistency across all engineering drawings.

- Ensure engineering drawings (including P&IDs, facility and equipment layouts, electrical, and mechanical drawings) are accurate, kept current, well organized, and readily available in their latest approved revision to the entire organization.

- Identify and lead continuous improvement and operational efficiency projects that increase reliability and throughput, reduce operating costs, and improve manufacturing performance.

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 to support normal business functions.

Job Requirements and Qualifications :

Required:

- 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:

- 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.

WHY JOIN SPL?

Our employees are our success!  We recruit motivated people, recognize their contributions, and support their development to reach their full potential.

Perks include: competitive compensation; excellent benefits package - including Medical, Dental and Vision on Day 1; Life and AD&D Insurance, and Short and Long-term Disability; Health and Flexible Saving Account options; Employee Assistance Program, generous vacation; paid Holidays; 401k; advancement opportunities; team-oriented environment; community involvement; company events and more!

SPL is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law.