Engineering Manager
Location: New Jersey
Our client is seeking an experienced Engineering Manager with expertise in Sterile Injectables and Drug Product Manufacturing to join their team. This full-time, exempt position is responsible for managing multiple departments within the engineering function. The ideal candidate will bring extensive knowledge of sterile environments, regulatory compliance, and engineering leadership within a biotech, pharmaceutical, or medical device setting.
Key Responsibilities:
- Engineering Leadership: Plan, direct, and implement developmental engineering functions, including:
- Establishing reliability standards for materials and design/production techniques.
- Overseeing the function and maintenance of mechanical systems and equipment.
- Leading research and technical design initiatives for electronic components, integrated circuitry, and other hardware systems.
- Sterile Injectables & Drug Product Manufacturing: Provide technical expertise in sterile environments, focusing on drug product manufacturing processes that meet stringent quality and safety requirements.
- Process & Safety Compliance: Ensure adherence to health, safety, FDA, and EU regulatory standards.
- System & Equipment Management: Develop and maintain the Engineering Change System, oversee equipment specifications and preventive maintenance, and ensure all technical documentation is current and accurate.
- Continuous Improvement: Lead Lean Manufacturing initiatives, research cost-effective upgrades, and recommend modifications to enhance equipment reliability and performance.
- Cross-functional Collaboration: Work closely with other departments to address and resolve engineering issues, often leading cross-departmental efforts.
- Personnel Management: Select, develop, and evaluate team members to ensure operational efficiency, set team goals, and provide effective guidance and resource allocation.
- Regulatory Compliance & Documentation: Track and complete routine and non-routine activities, conduct GAP analysis, and provide recommendations to maintain qualification standards.
Qualifications:
- Education: BS or MS in a related engineering field.
- Experience:
- Minimum 3 years in a biotech, pharmaceutical, or medical device environment.
- At least 3-5 years in a supervisory role in a similar setting.
- Specific experience with sterile injectables and drug product manufacturing is required.
- Project management experience is a plus.
- Skills:
- Strong problem-solving abilities, capable of prioritizing tasks in high-pressure environments, with excellent technical writing and self-training capabilities.
- Proficient in logical and analytical reasoning, with an ability to manage multiple priorities.
- Physical & Work Environment Requirements:
- Able to perform desk work and document editing, as well as operate in clean rooms, machinery rooms, and labs.
- Must be able to lift up to 25 lbs and navigate facility areas.
- Travel: Occasional travel may be necessary, including potential international trips for equipment assessments or business needs (lasting up to 2 weeks at a time).
This role is ideal for a driven leader with a strong background in sterile injectable manufacturing, who can ensure compliance, lead continuous improvement efforts, and drive operational excellence within a fast-paced and regulated environment.
