Manager, Process Utilities

Work Schedule

First Shift (Days)

Environmental Conditions

Able to lift 40 lbs. without assistance Adherence to all Good Manufacturing Practices (GMP) Safety Standards Cleanroom: no hair products jewelry makeup nail polish perfume exposed piercings facial hair etc... allowed Cold Room/Freezers -22degreesF/-6degrees C Fluctuating Temps hot/cold Loud Noises (Equipment/Machinery) Office Some degree of PPE (Personal Protective Equipment) required (safety glasses gowning gloves lab coat ear plugs etc.) Various outside weather conditions Warehouse Working at heights

Job Description

DESCRIPTION:

The Manager Process Utilities is responsible for the safe compliant reliable and efficient operation of site utility systems that support manufacturing laboratory and facility operations. This position provides leadership and technical oversight for the Process Utilities organization including licensed/raised-seal boiler operators utility technicians and other assigned personnel.

The Manager ensures critical utility systems are operated and maintained in accordance with applicable regulatory requirements environmental and safety standards site procedures and established engineering practices. The role is accountable for workforce development operational readiness system reliability regulatory compliance and continuous improvement of utility operations.

• Provide overall leadership and technical oversight for process and clean utility systems supporting pharmaceutical manufacturing operations.
• Ensure the safe reliable compliant and cost-effective operation of critical utility systems including:
  • Purified Water (PW)
  • Water for Injection (WFI) where applicable
  • Clean Steam / Pure Steam
  • Process and Clean Compressed Air
  • Process Gases including nitrogen and other specialty gases
  • Clean-in-Place (CIP) utility interfaces and associated distribution systems
  • Other GMP-critical process utilities supporting manufacturing laboratory and production areas
• Maintain utility systems in a validated and qualified state in accordance with GMP requirements site quality systems approved procedures and applicable regulatory expectations.
• Serve as the system owner or technical authority for assigned process utility systems ensuring appropriate lifecycle management system performance reliability and compliance.
• Develop and execute preventive and predictive maintenance strategies to maximize utility availability reliability and equipment lifecycle while minimizing unplanned manufacturing interruptions.
• Monitor system performance capacity quality attributes alarms trends and reliability metrics to proactively identify deterioration recurring issues and opportunities for improvement.
• Partner with Manufacturing Engineering Maintenance Quality Assurance Validation Automation EHS and Facilities to ensure utility systems continuously meet operational and GMP requirements.
• Lead or support investigations involving utility excursions equipment failures deviations environmental or quality events including root cause analysis and CAPA development and implementation.
• Provide technical leadership for commissioning qualification and validation (CQV) activities associated with new installations modifications expansions and major maintenance activities.
• Review and approve technical documentation as appropriate including specifications drawings P&IDs SOPs maintenance procedures qualification protocols change controls deviations CAPAs and engineering studies.
• Manage changes to GMP utility systems through established change control and quality risk management processes ensuring impacts to product quality validated state operations and regulatory compliance are appropriately assessed.
• Establish and maintain appropriate preventive maintenance calibration inspection sanitization and monitoring programs for clean utility equipment and distribution systems.
• Ensure appropriate control of critical parameters affecting utility quality including water chemistry microbiological control temperature pressure flow sanitization and distribution-loop performance.
• Support regulatory and customer inspections by providing system documentation technical expertise investigation support and responses related to process and clean utilities.
• Develop and maintain utility capacity and demand forecasts to support production requirements facility expansion new product introductions and long-term site planning.
• Identify and implement reliability energy-efficiency water-conservation sustainability and operational improvement initiatives without compromising GMP compliance or product quality.
• Manage utility-related projects operating budgets capital expenditures spare-parts strategies service contracts and external vendors.
• Establish and track key performance indicators (KPIs) for utility reliability availability compliance maintenance effectiveness deviations cost and system performance.
• Lead develop and mentor engineers technicians supervisors and/or utility operations personnel establishing clear technical standards responsibilities training requirements and performance expectations.
• Ensure utility operations and maintenance activities comply with applicable GMP EHS engineering electrical pressure-system and site safety requirements.
• Maintain a state of inspection readiness for all GMP-critical utility systems and ensure documentation accurately reflects current system configuration and operating practices.

Qualifications

Education

• Bachelors degree in engineering Facilities Management Industrial Technology or a related technical discipline preferred.
• Equivalent combination of technical education utility operating experience and leadership experience may be considered.

Experience

• Typically 7 years of experience in utilities facilities central plant boiler operations industrial maintenance or a related technical environment.
• Typically 3 years of supervisory or management experience leading operators technicians or skilled trades personnel.
• Demonstrated experience with industrial or commercial boiler and steam systems.
• Experience managing licensed boiler operators strongly preferred.
• Experience in pharmaceutical biotechnology medical-device semiconductor food chemical or other highly regulated manufacturing environments preferred.

Licenses & Technical Knowledge

Working knowledge of:

• Boiler and steam-generation systems
• Pressure vessels and associated safety requirements
• Chilled-water and cooling-water systems
• Compressed-air systems
• Water-treatment principles
• Utility distribution systems
• Building automation and utility-control systems
• Preventive and predictive maintenance
• Lockout/Tagout and industrial safety practices
• Utility-system troubleshooting and root-cause analysis

Knowledge of applicable state/local boiler operator licensing and raised-seal requirements is strongly preferred.

Leadership Competencies

The successful candidate will demonstrate:

• Strong commitment to safety and regulatory compliance
• Effective leadership of skilled technical personnel
• Sound judgment during utility emergencies and abnormal operating conditions
• Strong technical troubleshooting and problem-solving capabilities
• Ability to establish accountability while developing and supporting employees
• Effective communication with operators technicians engineers manufacturing leaders Quality EHS and senior management
• Ability to prioritize competing operational and maintenance demands
• Strong understanding of operational risk and business continuity
• Data-driven decision-making and continuous-improvement mindset

Working Conditions

• Work is performed in office manufacturing mechanical-room central-utility-plant and boiler-room environments.
• Position may require entry into areas with elevated temperatures noise rotating equipment chemicals and other industrial hazards while utilizing appropriate PPE.
• May require participation in an on-call or after-hours escalation rotation.
• Must be able to respond to critical utility events outside normal business hours when required.
• Periodic climbing of stairs ladders and access to mechanical equipment areas may be required.

Compensation and Benefits

The salary range estimated for this position based in New Jersey is $123800.00$183900.00.

This position may also be eligible to receive a variable annual bonus based on company team and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on which includes:

• A choice of national medical and dental plans and a national vision plan including health incentive programs

• Employee assistance and family support programs including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO) 10 paid holidays annually paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) accident and life insurance and short- and long-term disability in accordance with company policy

• Retirement and savings programs such as our competitive 401(k) U.S. retirement savings plan

• Employees Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits please visit: Experience:

Manager