Director/ Vp, Facilities & Engineering

• Establish and execute the facilities and engineering strategy aligned with company growth, clinical manufacturing capacity, and regulatory requirements.
• Provide executive oversight for GLP and GMP utilities, facilities operations, engineering lifecycle management, and capital projects.
• Serve as a member of site and/or corporate leadership, advising senior executives on infrastructure risks, opportunities, and investments.
• Define governance models, engineering standards, policies, and best practices across facilities and utilities.

• Provide executive oversight for the design, construction, commissioning, operation, and maintenance of GMP/ GLP manufacturing facilities, cleanrooms, process suites, utilities, solvent storage, laboratories and support infrastructure.
• Subject Matter Expert (SME) for clean room and site utilities, including HVAC, WFI, purified water, clean steam, clean gases, autoclaves, boilers, chilled water, cooling towers, and process chillers.
• Ensure utility and facility systems meet performance, reliability, capacity, and compliance expectations for 24x7 GMP/GLP operations.
• Lead development and execution of long-term capacity planning, asset lifecycle management, and site master planning.

• Provide leadership for capital projects, including new facilities, expansions, renovations, and system upgrades.
• Oversee engineering design, procurement, construction and commissioning activities.
• Ensure delivery of projects on time, within budget, and in compliance with safety and, applicable GMP and GLP requirements.
• Approve engineering strategies, specifications, P&IDs, design standards and other documents.

• Ensure full compliance with FDA, EMA, cGMP, OSHA, EHS, and other applicable regulatory requirements.
• Partner with Quality to support inspections, audits, deviation investigations, change control, CAPAs, and regulatory commitments.
• Provide executive oversight of risk management, reliability engineering, and business continuity planning related to facilities and utilities.

• Drive operational excellence through preventive and predictive maintenance strategies, reliability engineering, and performance monitoring.
• Leverage data analytics and KPIs to improve system availability, energy efficiency, sustainability, and cost effectiveness.
• Champion continuous improvement initiatives, digitalization, and modernization of facilities and utility systems.
• Ensure robust strategies to support operational transparency and decision-making.

• Lead, mentor, and develop a high-performing Facilities & Engineering team, including managers, engineers, and technicians.
• Build succession plans and ensure the organization has the technical capability and leadership depth to support future growth.
• Foster a culture of safety, accountability, compliance, and collaboration across all engineering and facilities teams.

• Serve as the primary executive liaison with external engineering firms, contractors, OEMs, and service providers.
• Negotiate and manage strategic vendor relationships, service contracts, and capital expenditures.
• Collaborate cross-functionally with Manufacturing, Technical Services, Quality, Regulatory, EHS, Finance, and Materials Management leadership.
• Perform other tasks and assignments as needed and specified by management.

• Executive-level expertise in GLP and GMP facilities and clean utility systems, including WFI, PW, clean steam, clean gases, HVAC, and plant utilities.
• Deep understanding of FDA, EMEA, cGMP, OSHA, and international regulatory standards.
• Proven leadership in capital project delivery, facility lifecycle management, and engineering governance.
• Strong understanding of engineering design, commissioning, and operational best practices.
• Ability to translate technical complexity into business-focused recommendations for senior leadership.
• Exceptional strategic thinking, financial acumen, and risk management skills.
• Excellent communication, negotiation, and executive presentation abilities.
• 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.

• Bachelor’s degree in Mechanical, Chemical, Biochemical, or Engineering Technology, or related field.

• 15+ years of relevant engineering or facilities experience.
• Minimum of 8 years of GMP experience preferred, including leadership of teams and capital projects.
• Prior experience at Director, Senior Director, or Vice President level strongly preferred.

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

Certificates and Licenses required:

N/A

Compensation:

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.