Lead Operator, Manufacturing - (Thurs-Sat Days)

Location: Cincinnati, OH – Center of Excellence for specialized oral solid dose manufacturing and drug development within the Pharma Services Group.

About the role

Formulation Technicians lead operations related to the manufacturing of pharmaceutical products, including equipment set-up, operation, clean-up, and maintenance in compliance with all regulatory cGMP requirements and company policies and procedures.

Responsibilities

• Provide and accurately follow production documents, standard operating procedures (SOPs), current good manufacturing practices (cGMPs), batch production records, cleaning forms, and assembly forms.
• Lead Operations teams in production activities such as disassembling, cleaning, and re-assembling equipment using basic hand tools (mixers, extruders, dryers, tablet press, encapsulation, coating pans, printers, tablet inspection machines).
• Work with SAP, Excel, Pharma Suite, BI Launch Pad, Maximo, and other software programs to support manufacturing operations.
• Lead manufacturing teams in the absence of production supervisors.

Requirements

• High school diploma or equivalent required.
• Minimum of 4 years of work experience in a manufacturing, operations, production, or lab setting (cGMP environment preferred).
• Mechanical proficiency to disassemble and reassemble various types of equipment.
• Advanced reading comprehension and math skills to follow technical instructions and complete BPR calculations.
• Proficiency with SAP, Microsoft Office, and other software systems.
• Ability to maintain compliance in all SOP, cGMP, EHS, and other training curricula.

Physical Requirements / Work Environment

• Able to lift 40 lbs. without assistance; manipulate/handle materials, equipment, and tools up to 100 lbs.
• Wear personal protective equipment, including white zone gowning and various styles of respirators (½ face, 3-M hood, full face, dust mask).
• Hand-scoop 5 lbs. intermittently throughout the workday.
• Operate a stand-up forklift and walkie stacker.
• Adhere to cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• No contact lenses allowed; prescription glasses will be provided.
• Work in environments with loud noises from equipment/machinery.

Schedule

Thursday–Saturday, Days: 6:00 AM–6:30 PM (12-hour shift).

Benefits

• Medical, dental, and vision benefits effective on day one.
• Paid time off and designated paid holidays.
• Retirement savings plan.
• Tuition reimbursement.
• Employee referral bonus.
• Annual performance-based bonus and merit-based pay increase.
• Career advancement opportunities.

Pay

Competitive hourly pay rate with additional shift differential for 2nd and 3rd shift positions.