Equipment Engineer

Job Overview:
We are seeking an Equipment Specialist to support manufacturing operations and ensure equipment reliability within a regulated production environment. The ideal candidate will provide hands-on technical expertise to troubleshoot, maintain, and improve equipment while collaborating with cross-functional teams. This role emphasizes problem-solving, process improvement, and promoting a culture of quality and operational excellence. Experience in highly regulated industries, including aseptic or sterile manufacturing, is highly valued.

Job Responsibilities:

• Troubleshoot and resolve equipment or process issues to maintain uninterrupted production.

• Collaborate with production staff to optimize equipment performance and address operational challenges.

• Partner with cross-functional teams to implement technical solutions and improvements.

• Support filling systems, formulation activities, inspection equipment, and packaging or labeling operations.

• Assess equipment performance and drive initiatives to enhance efficiency, reliability, and uptime.

• Contribute to updates and continuous improvement of standard operating procedures and documentation.

• Participate in risk assessments, such as process FMEAs, to identify and mitigate vulnerabilities.

• Provide ongoing technical support for manufacturing operations, including off-shift or weekend coverage.

• Ensure compliance with regulatory standards, including FDA, EU, ISO, and cGMP requirements.

• Mentor and support colleagues to foster continuous improvement and a culture of quality.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, or a related field with 3+ years of relevant experience, or High School Diploma/GED with 8+ years of experience.

• Strong knowledge of GMP practices and regulatory compliance requirements.

• Experience in biotech or pharmaceutical manufacturing, particularly aseptic/sterile processing, fill-finish, inspection, or labeling.

• Lean Six Sigma certification or equivalent process improvement experience preferred.

• Demonstrated ability to troubleshoot and maintain complex equipment in a regulated environment.

• Strong collaboration, communication, and problem-solving skills.

• Adaptable to flexible schedules, including off-shifts, weekends, or extended hours as needed.