Engineering Manager (Pharmaceutical Exp. Required--No exceptions)

KVK Tech
Newtown, PA

Job Description

Job Description

Department

Facilities & Engineering

Job Title

Engineering Manager

FLSA Status

Exempt

Reports To

Chief Executive Officer

1. Role Purpose:

The Facilities & Engineering Manager will be responsible for the oversight, strategic planning, and execution of facilities management and engineering functions at KVK Tech. This role will ensure that all company assets—including office spaces, laboratories, manufacturing, packaging, and warehouse facilities—are properly maintained, compliant with regulatory requirements, and optimized for operational efficiency. The Facilities & Engineering Manager will lead preventive and predictive maintenance programs, drive sustainability initiatives, and oversee capital projects while ensuring alignment with cGMP, FDA, DEA, OSHA, and EPA regulations.

This role combines high-level strategic planning with hands-on operational oversight, ensuring a cost-effective and compliance-driven approach to facilities and engineering management.

2. Key Duties & Responsibilities:

  • Oversee maintenance and repair of critical facility systems , including HVAC, electrical distribution, water systems, wastewater treatment, compressed air, boilers, chillers, and gas supplies.
  • Develop, implement, and maintain preventive and predictive maintenance programs to ensure minimal downtime.
  • Utilize technology-driven solutions , including IoT sensors and anomaly detection, to improve equipment reliability and efficiency.
  • Establish contracts with external vendors and service providers , ensuring quality and cost-effectiveness.
  • Ensure emergency response preparedness for facility-related issues, including fire suppression systems and security protocols.
  • Lead capital projects, facility upgrades, renovations, and expansions , ensuring compliance with safety and regulatory requirements.
  • Work closely with cross-functional teams to support facility layout optimization, process improvement, and automation initiatives .
  • Ensure proper qualification and validation (IQ/OQ/PQ) of new facility-related equipment and infrastructure.
  • Oversee the calibration program for all GMP equipment and instruments.
  • Ensure compliance with cGMP, FDA, DEA, OSHA, EPA, and local building codes for all facility operations.
  • Act as the SME (Subject Matter Expert) for facilities compliance during internal and external audits.
  • Lead efforts in environmental sustainability, energy efficiency, and carbon footprint reduction .
  • Implement and oversee EHS (Environmental, Health & Safety) programs , ensuring a safe and compliant work environment.
  • Manage and develop a team of maintenance personnel, engineers, and facility staff .
  • Set departmental goals, oversee performance evaluations, and create succession planning initiatives.
  • Develop and manage the facilities & engineering budget , ensuring cost control without compromising quality or compliance.
  • Drive a culture of continuous improvement, problem-solving, and operational excellence across the facilities and engineering functions.

3. Supervisory Responsibility

  • Directly manages a multi-disciplinary team of facilities, maintenance, and engineering professionals.
  • Oversees contractors and third-party service providers .
  • Leads cross-functional collaboration with Quality, Manufacturing, Validation, and Compliance teams.

4. Education & Experience

  • Bachelor’s degree in Engineering, Engineering Management, or related technical discipline ( or equivalent experience ).
  • Minimum 8-12 years of experience in facilities management, engineering, or maintenance, preferably in a GMP-regulated environment.
  • Proven experience in overseeing facility operations, utilities, maintenance programs, and capital projects.
  • Strong knowledge of FDA, DEA, cGMP, OSHA, and EPA regulations.
  • Experience in managing maintenance teams and facility operations within pharmaceutical, biotechnology, food manufacturing, or other regulated industries .
  • Hands-on expertise in mechanical, electrical, HVAC, and control systems .
  • Lean Six Sigma or Process Improvement Certification .
  • Project management experience (CAPEX, facility expansions, automation, and process optimization).
  • Experience with SCADA systems, PLCs, CMMS (Computerized Maintenance Management Systems), and automation controls .

5. Technical Competencies:

  • Strong knowledge of preventive & predictive maintenance methodologies .
  • Expertise in building systems, utilities, and environmental control technologies .
  • Hands-on experience in electrical, mechanical, and process control systems .
  • Ability to interpret blueprints, electrical diagrams, and engineering specifications .
  • Experience with energy conservation, sustainability, and cost-reduction initiatives .
  • Strong leadership and communication skills , with the ability to manage teams and influence cross-functional groups.
  • Proficiency in Microsoft Office, CMMS software, and engineering analytics tools (Minitab, JMP, AutoCAD, etc.) .

6. Physical Demands & Work Environment:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Posted 2025-09-15

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