Pharmaceutical Production Supervisor - All Shifts

Job Summary

Job Description

Shift/Hours:

Mon-Friday

1st: 6:00am-2:30pm
2nd: 2:00pm-10:30pm 
3rd: 10:00pm-6:30am 
 

Responsibilities:

• Lead end-to-end execution of the assigned ISO-classified cleanroom production line by verifying readiness (people, materials, documents, equipment), authorizing startup, supervising line operations, and ensuring accurate and timely batch documentation.

• Serve as the line’s compliance leader, enforcing cleanroom discipline (gowning, behavior, material and personnel flow) and GDP practices. Exercise authority to stop the line, escalate issues per procedure when controls are at risk, and correct any noncompliant behaviors in real time.

• Perform and document all pre-run requirements, including line clearance procedures, environmental checks, tooling and parameter verification, material/label reconciliation, and verifying documentation is current, approved, and applicable to the process.

• Maintain active presence on the floor to observe and ensure proper aseptic behaviors; provide timely coaching and corrective action; and stop work immediately when procedural drift is observed.

• Ensure timely and accurate completion of production records, performing proactive page reviews and coordinating with QA to achieve accurate and timely closure of records.

• Perform periodic in-process checks (functional and visual inspections) per MBR; quarantine nonconforming product promptly; and support on the floor triage and root cause assessment.

• Coordinate structured changeovers and cleaning, including oversight of in-between batch cleaning activities. Verify documentation quality and manage materials/logistics to maintain unidirectional flow and proper segregation.

• Initiate deviations with objective evidence, perform impact assessments, support investigations/root cause analysis, and drive immediate corrective actions. Escalate promptly in accordance with QCU authority.

• Direct daily work and coach operator performance, qualifying employees to standard work, reinforcing retraining needs, and partnering with Training to ensure records remain current.

• Champion safety and operational excellence by conducting Gembas, driving 6S and visual management standards, and leading Kaizen activities to reduce waste and improve OEE.

• Act as primary contact for Quality, Maintenance, Engineering, and Supply Chain, ensuring structured shift handoffs and timely communication when issues arise.

Required Experience:

• High school diploma or equivalent.

• 3 years of aseptic manufacturing experience in GMP and ISO-cleanroom environments.

• 2 years of previous leadership experience working in an FDA-regulated environment.

• Strong working knowledge of GMP regulations, aseptic techniques, and biopharmaceutical manufacturing processes, with the ability to execute work in compliance with SOPs, batch records, and technical documentation.

• Demonstrated attention to detail with the ability to accurately complete GMP documentation and support investigations and escalate issues.

• Effective communication and interpersonal skills, including the ability to guide and collaborate with others.

• Must be able to maintain active and constant presence inside ISO-cleanrooms.

• Fluently speak, read and write English.

• Flexibility to work a modified schedule.

Preferred Qualifications:

• Bachelor's degree in STEM field.

• 5 years of hands-on experience in GMP-regulated pharmaceutical or biopharmaceutical manufacturing.

• Effective problem solving/root cause analysis skills.

• At least 1 year of experience managing people, including hiring, developing, motivating and directing people as they work.

• Previous supervisory experience working in a FDA-regulated environment.

• Advanced knowledge of upstream and/or downstream bioprocessing operations

• Experience supporting audits, inspections, and regulatory interactions

• Familiarity with continuous improvement methodologies and operational excellence initiatives

• Strong problem-solving skills with the ability to work cross-functionally

Medline Industries, LP, and its subsidiaries, offer a competitive total rewards package, continuing education & training, and tremendous potential with a growing worldwide organization.

The anticipated salary range for this position:

The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible. Medline will not pay less than the applicable minimum wage or salary threshold.

Our benefit package includes health insurance, life and disability, 401(k) contributions, paid time off, etc., for employees working 30 or more hours per week on average. For a more comprehensive list of our benefits please click here. For roles where employees work less than 30 hours per week, benefits include 401(k) contributions as well as access to the Employee Assistance Program, Employee Resource Groups and the Employee Service Corp.

We’re dedicated to creating a Medline where everyone feels they belong and can grow their career. We strive to do this by seeking diversity in all forms, acting inclusively, and ensuring that people have tools and resources to perform at their best. Explore our Belonging page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified individuals without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, age, disability, neurodivergence, protected veteran status, marital or family status, caregiver responsibilities, genetic information, or any other characteristic protected by applicable federal, state, or local laws.