Physical & Safety Requirements
- Able to lift 40 lbs. without assistance.
- Adherence to all Good Manufacturing Practices (GMP) Safety Standards.
- Cleanroom compliance: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc.
- Cold room/freezer conditions –22°F / –6°C.
- Laboratory setting experience.
- Tolerance for loud noises from equipment or machinery.
- Some degree of personal protective equipment (PPE) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
- Ability to work in various outside weather conditions.
- Experience working with hazardous/toxic materials.
Key Responsibilities
- Lead and develop engineering teams to ensure operational excellence across manufacturing facilities.
- Drive continuous improvement in quality, efficiency, and innovation.
- Oversee new product introductions, equipment optimization, process improvements, and technical issue resolution.
- Collaborate closely with cross‑functional teams including R&D, Operations, Quality, and Supply Chain.
- Implement engineering solutions to support the organization’s mission and improve product safety and quality.
- Specify, procure, and implement capital equipment.
- Maintain professional focus in challenging situations and demonstrate a commitment to workplace safety and environmental compliance.
- Travel up to 25% for project support and site collaboration.
Qualifications & Experience
- Advanced degree plus 6 years of experience, or bachelor’s degree plus 8 years of experience in manufacturing engineering within a regulated industry (pharmaceutical, medical device, or high‑tech manufacturing).
- Preferred fields of study: Mechanical, Electrical, Chemical Engineering or related fields.
- Professional certifications (PE, PMP, Six Sigma) highly valued.
- 2+ years of people‑management/leadership experience preferred.
- Expertise in cGMP regulations, quality systems, and industry standards.
- Strong project management capabilities to lead cross‑functional initiatives.
- Experience with statistical process control, FMEA, DOE, and other quality tools.
- Proficiency in developing and optimizing manufacturing processes and documentation.
- Track record of implementing continuous improvement and cost‑reduction projects.
- Ability to analyze complex technical issues and develop data‑driven solutions.
- Excellent communication and interpersonal skills to work effectively across all levels.
- Knowledge of automation, Industry4.0, and digital manufacturing technologies.
- Proficiency with engineering software, MS Office, and manufacturing systems.
- Experience with Lean Manufacturing and Six Sigma methodologies preferred.
#J-18808-Ljbffr…
