Manufacturing Associate (2nd Shift)

Location: Wilmington, OH (Onsite) | Employment Type: Contract-to-Hire

About the Role

This role is responsible for performing manufacturing operations in a cGMP-regulated cleanroom environment, including equipment preparation, aseptic processing, documentation, and batch execution. The ideal candidate is detail-oriented, dependable, eager to learn, and comfortable working in a fast-paced manufacturing environment while maintaining strict quality and safety standards.

Responsibilities

• Perform equipment cleaning, assembly, setup, and operation for manufacturing processes.
• Execute batch processing activities for sterile microsphere, suspension, and liquid products.
• Read, understand, and accurately follow SOPs, Master Production Records (MPRs), and manufacturing procedures.
• Complete cGMP documentation accurately and in a timely manner.
• Monitor manufacturing processes with close attention to detail.
• Perform aseptic gowning and maintain gowning qualification.
• Conduct cleanroom and manufacturing area sanitization activities.
• Assist with equipment preparation and changeovers.
• Support process development and validation activities as needed.
• Follow all company policies, quality standards, and safety procedures.
• Perform additional duties as assigned by management.
• Provide shift and occasional weekend coverage when required.

Requirements

• High School Diploma or GED required.
• Ability to work onsite on a Monday–Thursday overnight schedule.
• 0–1 year of experience in sterile pharmaceutical or GMP manufacturing.
• Associate degree or higher in a science or technical discipline.
• Knowledge of aseptic manufacturing principles.
• Familiarity with Current Good Manufacturing Practices (cGMP), HAZCOM, RCRA, and general manufacturing safety requirements.

Skills & Attributes

• Positive attitude and strong work ethic
• High level of integrity and accountability
• Dependable and self-motivated
• Detail-oriented with excellent documentation practices
• Adaptable in a changing production environment
• Quick learner with a willingness to develop new skills
• Strong communication and teamwork skills
• Ability to prioritize tasks and respond quickly to production needs

Physical Requirements

• Ability to work in a sterile cleanroom while wearing full aseptic gowning, including hood, coveralls, boots, mask, goggles, and gloves.
• Maintain annual aseptic gowning qualification.
• Ability to stand for up to 7 hours while wearing steel-toed shoes.
• Frequent walking, bending, reaching, climbing, pushing, and pulling carts.
• Ability to operate manufacturing equipment, including HMI systems and autoclaves.
• Ability to lift up to 50 pounds independently and participate in team lifts up to 100 pounds.
• Ability to perform repetitive tasks throughout the shift.

Schedule

Monday–Thursday, 3:00 PM – 1:30 AM (4x10-hour shifts)

Pay

$21/hr – $22/hr

Benefits

• Contract-to-hire opportunity with long-term career potential
• Stable Monday–Thursday schedule with three-day weekends
• Hands-on experience in sterile pharmaceutical manufacturing
• Opportunity to develop GMP and aseptic manufacturing expertise
• Collaborative, safety-focused team environment