About this role
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 a Sr. Manager – Automation & Electrical Maintenance Engineering.
This position l eads the automation, electrical, and instrumentation team within the Engineering & Maintenance department at the SPL Waunakee site, with responsibility for both the engineering and the maintenance of these systems. Manage OT and process control systems, PLCs, GAMP compliance, electrical distribution and utilities, instrumentation, and other electrical and electronic systems in a cGMP environment, including security systems and the electronic components of fire protection and life safety systems. Oversee the site GMP metrology and calibration program, day-to-day automation and electrical maintenance, systems integration, and the automation and electrical scope of capital projects. Ensure automation, electrical, and instrumentation equipment is maintained and supported 24 hours a day, 7 days a week, including building and managing the team’s on-call rotation. Direct, review, coordinate, and approve electrical and automation activities for facility and production needs and set the technical standards the team works to. Perform duties at an elevated degree of professionalism, independence, and sense of ownership.
Responsibilities include :
- Lead the automation, electrical, and instrumentation team, including the Supervisor - GMP Metrology & Calibration, the Supervisor - Automation & Electrical Maintenance, and the engineering and systems integration staff, setting clear technical direction and priorities.
- Identify, recruit, train, and develop highly skilled automation, electrical, and instrumentation staff; set technical expectations, scope and estimate work, and evaluate work quality to support effective performance management.
- Ensure automation, electrical, and instrumentation equipment is maintained and supported 24 hours a day, 7 days a week: Build, staff, and manage the team’s on-call rotation, define response expectations and escalation paths, and confirm off-shift issues are resolved and documented.
- Direct, review, coordinate, and approve electrical activities for facility and production needs, including installation, maintenance, troubleshooting, and repair of facility electrical infrastructure and processing equipment.
- Own the site electrical distribution system and electrical utilities: Set electrical standards, define preventive maintenance requirements and schedules for electrical assets, and plan upgrades to maintain reliable power to production and facility systems.
- Own site security systems and the electronic components of fire protection and life safety systems, including maintenance, troubleshooting, upgrades, and required inspection and testing, in coordination with EHS and with the Mechanical Maintenance, Facilities & Asset Systems team, which owns the mechanical portions of these systems.
- Manage OT and process control systems, including PLCs, HMIs, SCADA, historians, and their supporting networks and infrastructure, keeping them reliable, secure, and supportable in coordination with IT; leverage real-time OT data to support maintenance decisions and throughput optimization.
- Oversee the site GMP metrology and calibration program through the Supervisor - GMP Metrology & Calibration, including scope, schedules, procedures, NIST-traceable standards, and out-of-tolerance (OOT) investigations and impact assessments; ensure non-GMP and utility calibrations performed by the Instrumentation & Controls Technicians meet defined standards.
- Set instrumentation and control loop standards for the site, including instrument specification, selection, installation practices, and lifecycle management.
- Evaluate equipment, programming, and systems for compliance with GAMP, and partner with the CSV & DI Compliance Manager so that automation changes are made under change control and preserve validated status and data integrity.
- Provide automation and electrical engineering oversight for capital projects: Set standards for automation and electrical scope, review and approve designs, and coordinate with the Head of Project Engineering and project managers to deliver high-quality installations on time and on budget.
- Design and review PLC programming, process controls, and electrical systems, and prepare layouts and technical specifications for construction, maintenance, and repair projects.
- Analyze system needs, perform calculations, and determine requirements for improvements; investigate applicable codes and standards, such as the National Electrical Code (NEC), NFPA 70E, and NFPA 72, and ensure SPL installations meet them.
- Ensure electrical safety practices, including lockout/tagout and arc flash protection, are established and followed for all electrical and automation work in coordination with EHS, and that department training meets GAMP, cGMP, OSHA, EPA, and other regulatory requirements as they relate to controls, electrical, and instrument issues.
- Develop policies and procedures for the maintenance, programming, and support of automation, electrical, and instrumentation systems.
- Apply thermal analysis and other predictive maintenance tools to electrical and automation systems, and maintain lifecycle and obsolescence plans, including OEM replacements and critical spares, in partnership with the Asset Reliability & Engineering Compliance team.
- Provide technical leadership for failure investigations, deviations, and CAPAs involving automation, electrical, and instrumentation systems, and lead continuous improvement in these areas.
- Develop and manage the team’s budget, and identify capital needs and develop appropriation requests for automation, electrical, and instrumentation systems.
Additional Responsibilities:
- Implement metrics necessary to monitor the effectiveness and continual improvement of the assigned functions.
- Serve as the automation, electrical, and instrumentation technical expert during regulatory inspections and customer audits.
- Ensure electrical and control drawings, schematics, and loop diagrams are updated after changes, working within the drafting standards owned by the Head of Project Engineering.
- 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, including automation, controls, and electrical systems.
Preferred:
- Electrical Engineering degree.
- Advanced degree in a Scientific discipline or other technical area.
- 5+ years of experience working in a regulated environment, including ISO, cGMP, GAMP 5, 21 CFR Part 11, and OSHA 1910.119 (PSM).
- 3+ years of people leadership of automation, electrical, or instrumentation teams.
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.