Senior GMP Manufacturing Lead & Technical Mentor

Haemonetics Software Solutions; Northern (KY); Hybrid; USD 29,000 - 50,000; Full time

Benefits offered by this job

401k match

Employee stock purchase plan

Flexible time off

Paid vacation

Paid sick time

Holidays

Parental leave

Disability insurance

Tuition reimbursement

Health benefits

Job summary

Haemonetics is seeking a GMP Associate III to serve as an area expert across manufacturing lines, providing technical leadership, troubleshooting, and guidance while prioritizing safety, quality, and output. You will support GMP, GDP, FDA, ISO 13485 compliance and lead by example in a fast-paced production environment.

The role requires staying fully qualified on all equipment and mentoring GMP I/II associates, with a focus on continuous improvement and Lean initiatives.

Qualifications

• High school diploma or equivalent; technical certification or additional training preferred.
• 2–4 years of experience in a GMP-regulated manufacturing environment (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 providing guidance to peers.
• Excellent attention to detail, problem-solving, and communication skills.
• Comfortable working in a fast-paced, team-driven environment.

Responsibilities

• Safety: model safe work practices, enforce PPE, guide GMP I/II on safe operation.
• Quality: maintain cleanroom discipline, GDP compliance, document control, inspect processes.
• Manufacturing & Delivery: operate, troubleshoot, and maintain equipment; manage materials and assembly tasks.
• Leadership & Mentorship: provide on-the-job coaching and technical guidance to teammates.
• Continuous Improvement: drive lean initiatives, root-cause analysis, and sustainable fixes.
• Company Values: uphold teamwork, accountability, and professional standards on the floor.

Skills

Attention to detail

Communication

Troubleshooting

Mentoring

Teamwork

Problem-solving

Education

High school diploma or equivalent

Job description

Haemonetics is seeking a GMP Associate III to serve as an area expert across manufacturing lines, providing technical leadership, troubleshooting, and guidance while prioritizing safety, quality, and output. You will support GMP, GDP, FDA, ISO 13485 compliance and lead by example in a fast-paced production environment.

The role requires staying fully qualified on all equipment and mentoring GMP I/II associates, with a focus on continuous improvement and Lean initiatives.