Specialist, Manufacturing (Biomanufacturing)

Location: Blue Ash, Ohio, USA; onsite work in controlled and non-classified manufacturing areas

Salary: $26.00–$39.00 per hour

Company

Technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Operate manufacturing and defect laboratory equipment in accordance with cGMP, EHS, quality, and safety standards.
• Create defect units for inspection defect kits and support visual inspection standards.
• Perform visual, cosmetic, and physical inspections, line clearances, kit reconciliation, and OEE data collection.
• Complete GMP documentation, batch record entries, logs, mathematical calculations, and process document reviews.
• Support investigations, resolve visual inspection issues, and collaborate with cross-functional teams.
• Participate in 5S, Kaizen, problem-solving, manual data collection, and other process improvement activities.

Requirements

• Prior experience in a pharmaceutical or cGMP-regulated environment.
• Ability to understand, read, write, communicate, and follow instructions in English.
• Strong attention to detail with the ability to maintain accurate records and perform mathematical calculations.
• Ability to work with handheld tools and different types of glass.
• Ability to pass an eye exam and meet visual requirements, including 20/20 or better vision with or without correction, color identification, and visual acuity.
• Ability to work safely in a changing environment and complete occasional overtime with limited advance notice.

Nice to have

• High school, vocational school, or equivalent education.
• Prior production experience.
• Experience in lean manufacturing and knowledge of cGMPs and FDA policies and procedures.
• Training for cold-room access or certification as a process-task trainer.

Culture & Benefits

• Eight-hour Monday–Friday schedule, subject to operational changes and business needs.
• Annual cash bonus program and 401(k) plan with company match.
• Medical, dental, vision, life, and disability insurance.
• Paid vacation, holidays, and other leaves of absence.
• Tuition reimbursement, family-building benefits, and caregiving support.
• Visa and work authorization sponsorship or support is not available.