Lead Operator, Manufacturing - (Mon-Wed 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 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 to include mixers, extruders, dryers, tablet press, encapsulation, coating pans, printers, or tablet inspection machines.
• Work with SAP, Excel, Pharma suit, BI Launch Pad, Maximo, and several other software programs to provide support to 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, tools up to 100 lbs.
• Cleanroom environment: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, or facial hair allowed.
• No contact lenses allowed; prescriptive glasses will be provided.
• Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
• Position requires wearing 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.
• Standing for full shift.
• Exposure to loud noises (equipment/machinery).

Schedule

• 12-hour shift, Monday–Wednesday, Days: 6:00 AM–6:30 PM.
• Additional shift differential for 2nd and 3rd shift positions.

Pay

Competitive hourly pay rate with annual performance-based bonus and merit-based increase.

Benefits

• Medical, Dental, & Vision benefits effective Day 1.
• Paid Time Off & Designated Paid Holidays.
• Retirement Savings Plan.
• Tuition Reimbursement.
• Employee Referral Bonus.
• Career Advancement Opportunities.