Manufacturing Production Operator

Department: Manufacturing • Location: Philadelphia, PA (on-site) • 4 openings

About the role

As a Manufacturing Production Operator you will follow batch records, SOPs, and company policies to manufacture pharmaceutical products. You will set up, operate, and clean equipment, perform in-process testing, and maintain accurate documentation under cGMP and FDA regulations.

Responsibilities

• Receive shift instructions from the manufacturing manager/supervisor and collect required batch-record information.
• Follow batch-record instructions to manufacture product.
• Ensure cleanliness and proper assembly of manufacturing equipment per approved SOPs.
• Comply with batch records, SOPs, and all company policies at all times.
• Perform all in-process testing and inspections as required by the Master Batch Record.
• Complete and sign batch records where appropriate.
• Report any issues that arise during the manufacturing process to the supervisor.
• Notify supervisor upon batch completion and receive new batch assignment.
• Ensure accurate completion of equipment logs, line clearance, and/or lab notebooks.
• Weigh out material and components for production batches.
• Identify and report quality issues.
• Report accidents, unsafe conditions, or unusual circumstances to the manufacturing manager/supervisor.
• Understand and adhere to all cGMP and FDA regulations.
• Maintain a neat and orderly work area at all times.
• Clean and sanitize manufacturing rooms including walls, floors, and ceilings per current SOPs.
• Set up, operate, and clean manufacturing equipment and suites.
• Perform additional duties as assigned by management.

Requirements

• High school diploma or equivalent.
• 2–4 years of relevant industry/manufacturing experience, preferably in GMP/FDA-regulated environments.
• Ability to read, comprehend, and apply pharmaceutical cGMPs, SOPs, Batch Records, and training documents.
• Ability to perform all requirements independently with limited managerial oversight.
• Superior attention to detail to ensure accuracy of work product.
• Must be free from illness that could jeopardize product safety or quality (e.g., contagious illness, conditions causing bleeding, open lesions, flaking or peeling skin).
• Ability to wear all types of required protective equipment.
• Ability to work on first and/or second shift, as well as overtime when required.
• Ability to perform physical tasks associated with sampling and inspecting.
• Highly organized, reliable, detail-oriented, self-starter able to multi-task and prioritize effectively.

Skills

• Excellent verbal and written communication in English.
• Ability to present information and respond to questions from other departments.
• Ability to perform mathematical calculations (addition, subtraction, multiplication, division, averages, percentages, fractions).
• Strong reasoning ability to identify problems early and determine effective solutions.
• Logical thinking with emphasis on delivering high levels of service.
• Excellent listening and comprehension skills.
• Ability to collaborate and support the objectives of other teams.
• Ability to give clear direction and instructions.
• Ability to remain calm under pressure and adapt positively to change.
• Professional appearance and positive attitude.

Physical demands

• Regularly required to stand for 8 hours and use hands to finger, handle, or feel.
• Frequently required to reach with hands and arms.
• Required to stand, walk, bend, talk, and hear.
• Must occasionally lift, push, or pull up to 50 pounds.
• Specific vision abilities required include close vision and ability to adjust focus.

Work environment

• Moderate to loud noise level.
• Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.