GMP Manufacturing Lead & Equipment Specialist

Haemonetics Corp; Pennsylvania; On-site; USD 29,000 - 50,000; Full time

Job summary

Haemonetics Corp is seeking a GMP Associate III to act as an area expert across all manufacturing lines, providing technical leadership, troubleshooting, and guidance to less experienced associates while ensuring safety, quality, and regulatory compliance.

The Working schedule is 4x10-hour shifts (Thursday night into Monday morning); you will operate, troubleshoot, and maintain equipment, mentor GMP I/II staff, and collaborate with Production, Quality, and Engineering to sustain high output.

Qualifications

• High school diploma or equivalent; technical certification preferred.
• 2-4 years in GMP-regulated manufacturing (medical device, pharmaceutical, or biotech preferred).
• Fully qualified and trained on all equipment within the manufacturing area.
• Strong understanding of GMP, GDP, FDA, and ISO 13485 compliance standards.
• Demonstrated ability to troubleshoot and resolve complex equipment and process issues.
• Proven track record of mentoring, coaching, or guiding peers.
• Excellent attention to detail, problem-solving, and communication skills.
• Able to thrive in a fast-paced, team-driven environment.

Responsibilities

• Act as a role model for safe work practices and PPE compliance.
• Maintain GMP/GDP documentation and cleanroom discipline.
• Operate, troubleshoot, and maintain all equipment across the manufacturing area.
• Lead loading, replenishing materials, packaging, and assembly tasks.
• Support TPM activities and minimize downtime.
• Provide on-the-job coaching and mentorship for GMP I/II staff.
• Drive lean initiatives (5S, Kaizen) and root-cause analysis.
• Uphold company values and foster teamwork.

Skills

GMP knowledge

Troubleshooting

Mentoring

Teamwork

Attention to detail

Education

High school diploma

Technical certification

Job description

Haemonetics Corp is seeking a GMP Associate III to act as an area expert across all manufacturing lines, providing technical leadership, troubleshooting, and guidance to less experienced associates while ensuring safety, quality, and regulatory compliance.

The Working schedule is 4x10-hour shifts (Thursday night into Monday morning); you will operate, troubleshoot, and maintain equipment, mentor GMP I/II staff, and collaborate with Production, Quality, and Engineering to sustain high output.