Sr. Manager/ Associate Director, Facilities & Engineering

The Sr. Manager/ Associate Director, Facilities & Engineering will provide technical and engineering support for critical utilities and facilities used in GMP manufacturing. This role will lead the design, implementation, and maintenance of new and existing utility systems, ensuring reliable and compliant operations that support pharmaceutical manufacturing and product quality. He/ she will collaborate cross-functionally with Facilities, Engineering, Manufacturing, Quality, and external vendors to optimize systems performance, resolve technical issues, and drive continuous improvement in facility and utility operations. The incumbent works cross-functionally with internal departments and external resources on facilities and engineering related issues. The Sr. Manager/ Associate Director, Facilities & Engineering supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

Primary responsibilities:

• Lead the design and layout of plant systems, utilities, and manufacturing areas including clean utilities and high potent containment (e.g., cleanrooms, process suites, utilities and solvent storage and handling).
• Plan, coordinate, and execute engineering analysis related to pharmaceutical plant operations and process/equipment optimizations. Develop strategy and processes to support 24X7 operations, including troubleshooting and optimization of equipment operational issues, preventive maintenance and system upgrades.
• Interface with stakeholders, vendors, and contractors to align designs and current operations with technical requirements and operational schedules.
•  Provide technical expertise in clean and plant utilities, including HVAC, WFI, autoclaves, purified water, clean steam, and clean gas systems.
• Develop, update and review engineering documentation such as design specifications, P&IDs, User Requirements, Functional Specifications, protocols (FAT/SAT/IQ/OQ/PQ), SOPs, and reports.
• Plan and execute preventive and corrective maintenance programs for utility and facility systems.
• Serve as subject matter expert (SME) in the areas of plant utilities, facilities, engineering and manufacturing equipment. 
•  Lead identification, root cause and resolution issues, including all aspects of deviation investigations, change control, and CAPAs.
• Monitor utility performance through data analysis, statistical methods, and reliability assessments.
• Collaborate with internal and external stakeholders to ensure systems meet technical, operational, and GMP compliance standards.
•  Act as a liaison between the Facilities & Engineering team, manufacturing operations, and quality departments.
•  Ensure all activities adhere to FDA, EMEA, GMP, OSHA, and other applicable regulatory requirements.
• Support continuous improvement projects to enhance system performance, energy efficiency, and reliability.
• Ensure building operations comply with all local building codes, zoning laws and regulations.
• Establish and maintain relationships and contracts with external vendors.
• Review fixed asset inventory and update as required.
• Maintain site compliance related to environment, health, and safety.
• Develop and implement processes necessary to operate the facility, including non-GMP cleaning/housekeeping, badging/security, and pest control.
• Make recommendations to promote efficiencies and apply a proactive approach to potential operational/environmental hazards/risks.
• Manage projects in support of space planning and expansion across all locations to meet hiring requirements.
• Develop and maintain budgets and long-range facilities plans based on company growth and future needs.
• Perform other tasks and assignments as needed and specified by management.

Required Knowledge, Skills and Abilities:

• In-depth understanding and knowledge of clean utility systems (WFI, purified water, clean steam, clean gases) and plant utilities (HVAC, boilers, chilled water, cooling towers, process chillers).
• Knowledge of GMP, FDA, EMEA and OSHA standards applicable to pharmaceutical manufacturing.
•  Ability to interpret and develop engineering drawings (P&IDs, equipment layouts, GA drawings).
• Requires relevant work experience in Utilities Systems, Facilities equipment, Building Management/Control Systems (BMS), design, build and operational support.
• Must have strong attention to technical details including engineering life cycle principles, with strong mechanical, instrumentation, electrical and process hands on capabilities.
• Strong troubleshooting and problem-solving skills with a focus on root cause analysis.
• Excellent technical writing and documentation skills.
• Strong collaboration, project management, and communication abilities.
• Mechanical, electrical, and process systems hands-on capabilities.
• Proficiency with Microsoft Office
• Excellent verbal and written communication skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
•  Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as required to fulfill business needs.

Education and Experience Requirements:

•  Bachelor’s degree in Mechanical, Chemical, Biochemical, or Engineering Technology, or related field.
• 10 years of relevant engineering or facilities experience.
• Minimum of 5 years of GMP experience preferred.

Physical Demands:

• Ability to stand, walk, sit, reach, climb, balance, stoop, kneel, crouch, or crawl as required.
•  Ability to lift and/or move up to 40 pounds.
•  Requires hearing, vision, and speaking within normal ranges for communication and inspection activities.

Working Conditions:

• Mechanical Spaces including close proximity to boilers and HVAC systems.
• Laboratory/Manufacturing environment including areas with high potent materials.
• Outside

Compensation:

       $120,000-$180,000 per annum

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

Salary : $120,000 - $180,000