Manufacturing Operator I
Department: Manufacturing / Operations
Location: Dyersburg, TN
Reports To: Manufacturing Supervisor / Production Lead
Classification: Full-Time, Non-Exempt
Position Summary
The Manufacturing Operator I is responsible for supporting the production of terminally sterilized bioidentical hormone replacement therapy (bHRT) drug products in a controlled cleanroom manufacturing environment. This entry-level role performs routine manufacturing tasks in accordance with current Good Manufacturing Practices (cGMP), site Standard Operating Procedures (SOPs), and approved batch records.
This position plays an important role in ensuring products are manufactured safely, accurately, and in compliance with regulatory and quality requirements. The ideal candidate is dependable, detail-oriented, comfortable working in structured environments, and committed to following procedures exactly as written.
Essential Duties & Responsibilities
Manufacturing Operations
- Perform assigned manufacturing steps for terminally sterilized bHRT products according to approved batch records and SOPs.
- Weigh, stage, verify, and transfer raw materials and components into classified production areas.
- Prepare equipment and production rooms for manufacturing activities.
- Support product processing activities including compounding, filling, packaging, and material handling.
- Perform line clearances and verify readiness of rooms and equipment prior to production.
- Assist with product inspection and packaging activities as required.
- Follow production schedules and communicate delays or operational concerns promptly.
Cleanroom & Environmental Control
- Perform proper gowning/degowning and maintain cleanroom discipline in classified manufacturing areas.
- Maintain aseptic behavior and practice good aseptic techniques when working with drug substances
- Adhere to controlled environmental requirements including temperature, humidity, and contamination control procedures.
- Maintain clean and orderly workspaces during and after operations.
- Clean and sanitize equipment and manufacturing rooms per approved procedures.
- Report any environmental or cleanliness concerns immediately.
Documentation & Compliance
- Complete batch records, equipment logs, and forms accurately and in real time.
- Follow Good Documentation Practices (GDP), including legible, complete, and contemporaneous documentation.
- Verify labels, materials, and product status before use.
- Identify and report deviations, documentation errors, or nonconformances to supervision.
- Maintain compliance with cGMP requirements and company policies.
Safety & Teamwork
- Follow all site safety requirements and wear required PPE.
- Handle materials and equipment safely.
- Participate in required onboarding, training, and qualification activities.
- Work effectively with production, quality, warehouse, and maintenance personnel.
- Support continuous improvement and operational efficiency initiatives.
Qualifications
Required
- High school diploma or GED.
- Ability to read, understand, and follow written procedures.
- Strong attention to detail and ability to perform repetitive tasks accurately.
- Ability to maintain accurate handwritten and/or electronic records.
- Ability to work independently and as part of a team.
- Reliable attendance and punctuality.
- Basic math skills.
Preferred
- Previous work experience in a regulated manufacturing environment such as:
- Pharmaceutical / cGMP
- Food or beverage production
- Medical device manufacturing
- Cleanroom or controlled environment operations
- Experience following SOPs, batch records, or work instructions.
Work Schedule
- Regular schedule: Monday through Friday, 9:00 AM – 6:00 PM
- Schedule may vary based on production requirements, batch schedules, equipment readiness, or operational priorities.
- Overtime will be required during periods of business need, including extended weekday hours and occasional weekend support.
- Employees are expected to maintain flexibility and reliable attendance to support manufacturing operations and customer commitments.
Physical Requirements
- Ability to stand and walk for extended periods throughout the shift.
- Frequent bending, reaching, and repetitive hand movements.
- Ability to lift and move materials up to 40 pounds.
- Ability to wear cleanroom gowning and PPE for extended periods.
- Ability to work in tightly controlled temperature- and humidity-regulated manufacturing environments.
Work Environment
- Classified pharmaceutical cleanroom and controlled manufacturing areas.
- Routine gowning and PPE required.
- Strict adherence to cGMP, contamination control, and documentation requirements.
- Work may involve repetitive tasks and production deadlines.
Success in This Role Looks Like
- Follows procedures consistently and accurately.
- Maintains cleanroom discipline and compliance.
- Completes documentation correctly the first time.
- Demonstrates reliability, accountability, and teamwork.
- Learns manufacturing processes quickly and contributes to safe, efficient operations.
Pay: From $20.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Employee discount
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
