Lead Operator, Manufacturing - (Mon-Wed Nights)

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 are responsible for performing operations related to the manufacturing of pharmaceutical products through 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, including mixers, extruders, dryers, tablet presses, encapsulation, coating pans, printers, or 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 or related field.
• Experience in a cGMP environment preferred.
• Mechanical proficiency and ability to disassemble and reassemble various types of equipment (GMP facility preferred).
• Advanced reading comprehension and math skills critical to follow sophisticated technical instructions and complete BPR calculations.
• Proven proficiency with SAP, Microsoft Office, and other software systems.
• Ability to maintain compliance in all SOP, cGMP, EHS, and other training curriculum as assigned.

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 (1/2 face, 3-M hood, full face, and dust mask).
• Hand-scoop 5 lbs. intermittently throughout the workday.
• Operate a stand-up forklift and walkie stacker.
• Adhere to all Good Manufacturing Practices (GMP) and safety standards.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• No contact lenses allowed; prescription glasses will be provided.
• Exposure to loud noises (equipment/machinery).

Schedule

• Mon–Wed Nights: 6:00 PM – 6:30 AM (12-hour shift).

Pay

Competitive hourly pay rate with additional shift differential for 2nd and 3rd shift positions. Includes annual performance-based bonus and merit-based increase.

Benefits

• Medical, dental, and vision benefits effective on day 1.
• Paid time off and designated paid holidays.
• Retirement savings plan.
• Tuition reimbursement.
• Employee referral bonus.
• Career advancement opportunities.