Job Summary
Join our dynamic manufacturing team as a Batch Manufacturing Operator at Levels I, II, or III in the medical device industry. In this energetic role, you will be integral to producing high-quality products through precise batch processing, ensuring adherence to safety and quality standards. You will operate various manufacturing equipment, handle materials efficiently, and support continuous improvement initiatives. This position offers a fantastic opportunity to develop your skills in a fast-paced environment dedicated to excellence in production.
Responsibilities
- Prepare, process, and package batches according to approved manufacturing instructions and batch records
- Set up, operate, and monitor mixing, blending, and packaging systems; verify critical parameters and equipment status
- Perform and document in-process quality checks; make within-scope adjustments and notify Quality of potential issues
- Troubleshoot routine equipment/process issues, document actions taken, and escalate complex problems appropriately
- Ensure line clearance, component verification, and label reconciliation are completed per GMP requirements
- Maintain accurate batch records, logbooks, and electronic entries in compliance with data integrity expectations (ALCOA)
- Mentor and train Batch Manufacturing I employees on SOPs, safety, and documentation best practices
- Support lean/continuous improvement initiatives, including 5S, waste reduction, and standard work updates
- Prior experience in manufacturing, laboratory work, or warehouse environments is preferred but not required; training will be provided.
- Ability to operate forklifts safely; certification is a plus.
- Familiarity with CGMP guidelines and good documentation practices is advantageous.
- Hands-on experience with materials handling, machining, or packaging equipment is desirable.
- Strong attention to detail with excellent organizational skills to manage multiple tasks efficiently.
- Physical ability to stand for extended periods, lift heavy objects, and perform manual tasks safely.
- Basic understanding of lean manufacturing principles to support process improvements. Join us in a role that combines technical skill development with meaningful contributions to our production goals! We’re committed to fostering a safe, engaging environment where your talents can thrive while making a tangible impact on our quality products.
Required:
- High school diploma or equivalent (technical certification or coursework is a plus)
- 2–4 years of manufacturing experience, preferably in medical devices, pharmaceuticals, or other regulated industries
- Working knowledge of GMP, SOP adherence, and controlled documentation practices
- Demonstrated ability to operate and monitor production equipment and follow process parameters
- Strong problem-solving skills with ability to recognize and escalate deviations and nonconformances
- Ability to work independently, prioritize tasks, and collaborate effectively within a production team
Preferred:
- Experience working under FDA Quality System Regulation (21 CFR 820) and/or ISO 13485 requirements
- Experience with electronic batch records (EBR), ERP systems, or barcode scanning in manufacturing
- Prior experience training or mentoring peers in a production environment
Pay: $21.00 - $30.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Work Location: In person
