Senior Director Engineering & Facilities

COMPANY OVERVIEW 

Halo Pharmaceutical is a technology-focused contract manufacturing business with differentiated applications and capabilities in solid, semi-solid and liquid dosage forms, with a particular focus on controlled substances. Halo has long-standing commercial relationships with a number of major pharmaceutical companies and maintains facilities in both the United States and Canada. 

Our family of companies offers complete CDMO services including custom synthesis of intermediates, reference standards, drug substances and drug product manufacturing. Halo Pharma is now part of Noramco. We are stronger together!

POSITION SUMMARY 

The Senior Director of Engineering and Facilities is a strategic and operational leader responsible for overseeing all engineering, maintenance, utilities, and facility operations supporting both Oral Dosage Forms (ODF) and Sterile manufacturing environments. This individual ensures facility and equipment reliability, regulatory compliance, and operational readiness across all technical areas of the site. The Sr. Director will lead cross-functional teams through design, construction, commissioning, qualification, and maintenance of process and facility systems, ensuring seamless integration with production and compliance goals.

The successful candidate will be a seasoned professional with 10–15 years of leadership experience in GMP-regulated pharmaceutical environments, facility design, critical-utilities maintenance, manufacturing and packaging equipment installation / maintenance and management, predictive maintenance, and reliability engineering. Experience in managing capital budgets in excess of $10 million per year, including familiarity with pharmaceutical-equipment vendors such as Groninger, Glatt, SKAN, Steris, Korsch, FETTE, MG2, etc. is required.  100% on site - Whippany, NJ

ESSENTIAL FUNCTIONS 

Strategic and Operational Leadership

• Develop and execute the site’s Engineering and Facilities strategy in alignment with overall business and operational objectives.
• Lead engineering, maintenance, facilities, utilities, and security functions ensuring compliance, safety, and operational excellence.
• Partner closely with Manufacturing, Quality, Product Development, Validation, Supply Chain, and EHS to ensure business continuity and readiness for regulatory inspections.
• Own and manage the site’s Capital Project portfolio, ensuring timely and cost-effective delivery of infrastructure, equipment, and facility upgrades.

Technical and Engineering Oversight

• Oversee the design, construction, commissioning, and qualification of new process and utility systems supporting ODF and Sterile operations.
• Direct and oversee all process-validation and equipment-qualification activities across both OSD and Sterile Injectable manufacturing. This includes full life-cycle commissioning and qualification,IQ, OQ, PQ, and PPQ,of production and utility systems, ensuring compliance with site Validation Master Plan requirements. The Sr. Director will lead or approve commissioning and qualification of systems such as Groninger filling lines, SKAN isolators, Steris sterilization and CIP / SIP equipment, blending and compression platforms, MG2 encapsulators, and related OSD process equipment. Validation oversight also extends to utilities (WFI, clean steam, HVAC, compressed gases, and environmental-monitoring systems) and to process validation for both OSD and Sterile Injectables, including media-fill simulations, sterilization-cycle validation, and cleaning-validation protocols.
• Ensure all facility and process systems meet GMP, FDA, DEA, and environmental requirements.
• Drive Reliability Engineering initiatives to optimize equipment uptime, preventive / predictive maintenance, and life-cycle asset management.
• Supervise the operation and maintenance of critical utilities including WFI systems, clean steam, HVAC, compressed air, chilled water, and purified-water systems.
• Serve as the engineering authority during audits, regulatory inspections, and client technical reviews.

Project Management and Continuous Improvement

• Lead and manage multi-million-dollar construction and equipment-installation projects from concept through qualification.
• Apply Lean and Continuous-Improvement methodologies (Kaizen, 5S, Value-Stream Mapping) to enhance technical efficiency and reduce operational costs.
• Ensure all new and existing systems are validated and qualified per cGMP requirements.
• Collaborate with internal stakeholders and external engineering firms to develop detailed scopes, budgets, and project schedules.

Financial and Compliance Accountability

• Develop and manage annual departmental budgets, including operating expenses and capital expenditures.
• Monitor energy efficiency, maintenance costs, and resource utilization to optimize financial performance.
• Ensure strict compliance with controlled-substance regulations, environmental health and safety requirements, and company standards.
• Oversee SOP management, change control, investigations, and CAPA execution related to facilities and utilities.

Leadership and People Development

• Build, mentor, and lead a high-performing engineering and facilities team fostering accountability, innovation, and continuous development.
• Establish clear performance metrics, conduct reviews, and drive professional-growth initiatives.
• Promote a culture of collaboration, transparency, and technical excellence across departments.
• Responsible for X departments with up to Y direct reports and Z indirect reports at a single site.

POSITION QUALIFICATIONS

EDUCATION:      

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, or Industrial preferred).
• Master’s degree or Professional Engineering (PE) license a plus.

EXPERIENCE:

• 10 years in technical process-engineering support within bio / pharma facilities.
• 5 years in engineering / maintenance support for licensed bio / pharma manufacturing.
• 8 years managing professional and technical staff.
• 5 years managing managers with performance accountability.
• 5 years working with external design and construction contractors.
• 5 years engaging with customers in a CMO business model.
• 5 years navigating regulatory and GMP requirements for licensed bio / pharma operations.
• 2 years working with financial systems and understanding accounting practices.
• Proven success leading facility design, construction, and equipment qualification projects in GMP-regulated environments.
• Strong background in Reliability Engineering, Predictive and Preventive Maintenance, and Utility-Systems Management.
• Demonstrated experience with controlled-substance operations under DEA compliance.
• Proficiency in Lean Manufacturing, Six Sigma, and project-management methodologies (PMP preferred).
• Expertise in capital planning, budgeting, and technical-risk management.
• Familiarity with SAP, AutoCAD, HMI and PLCs (Allen Bradley, Siemens etc.) and computerized maintenance-management systems (CMMS).

KEY COMPETENCIES

• Strategic and analytical thinking
• Technical and regulatory acumen
• Cross-functional leadership and communication
• Project and financial management
• Problem-solving and decision-making under pressure
• Strong interpersonal and negotiation skills
• Adaptability to dynamic environments

PHYSICAL AND ENVIRONMENTAL REQUIREMENTS

• Must be able to move throughout the facility, including production and utility areas.
• May be required to wear PPE and enter cleanrooms.
• Ability to remain sedentary for extended periods during planning and reporting activities.
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 Halo Pharma provides a pay range for this role in accordance with applicable pay transparency laws. Individual pay rates are determined by assessing expertise, skills, education, and professional background

Halo is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.