The Manufacturing Technician I is responsible for operating and maintaining processing equipment, preparing components for aseptic and non-aseptic operations, and ensuring compliance with Good Manufacturing Practices (GMP) in a cleanroom environment. The role includes completing or supporting activities such as sanitization of facility, equipment cleaning and assembly, material handling/transferring, formulation, filling, inspection, packaging, and any other manufacturing operations.
Responsibilities
- Perform routine cleaning and sanitization of production areas to maintain a controlled and compliant environment.
- Prepare and transfer materials and components for production using proper sanitization techniques and aseptic handling practices.
- Utilize proper aseptic techniques in Grade B/C/D and CNC environments during all tasks.
- Adhere to safety and environmental health standards, including proper use of PPE.
- Perform inspection, labeling, and packaging of vials, IV bags, and syringes.
- Operate and maintain equipment used across all production processes, including formulation, filling, sterilization, inspection, and packaging with support and oversight from other manufacturing team members.
- Complete all GMP documentation, including batch records, protocols, and deviations, adhering to Good Documentation Practices (GDP).
- Collaborate cross‑functionally with production, QA, QC, engineering, validation, and maintenance teams as required.
- Recognize and report deviations, potential issues, or equipment malfunctions to the management team.
- Load, operate, and unload sterilization equipment, such as autoclaves, terminal sterilizer, and HEPA transfer carts.
- Maintain consistent presence on manufacturing floor and support all teams in production as needed.
- Assist with dispensing and formulating raw materials for aqueous and non‑aqueous products, ensuring accuracy and compliance with batch records.
- Assist with set up and operate filling lines and associated equipment, including mixers, tanks, pumps, autoclaves, and HEPA transfer carts.
- Assist with preparing equipment for use using sterilization equipment such as autoclaves and HEPA cabinets.
Requirements
- High School Diploma or equivalent required. An associate degree in a technical field or a bachelor’s degree in biological, chemical sciences, or engineering preferred but not required.
- Experience regulated manufacturing environments, pharmaceutical preferred.
- Mechanical aptitude to operate and troubleshoot a variety of equipment and instruments.
- Understanding of GMP and GDP standards.
- Strong attention to detail, with the ability to follow SOPs, complete documentation tasks accurately.
- Basic computer skills and familiarity with technical documentation.
- Mathematical skills for measurements and calculations (e.g., volume, weight).
- Physical ability to raise arms over head, stoop, stand, climb, and lift 30‑50 lbs.
- Effective verbal and written communication skills.
- Prolonged periods of standing, walking, or working in a cleanroom environment.
- Ability to wear fully protective gowning for extended periods.
- Must be able to lift and transport materials weighing up to 50 lbs.
- Ability to arrive at work consistently for assigned shifts.
Shift Differential Opportunity
- We have three shifts available:
- 1st shift - 7:00 am – 3:30 pm (Monday ‑ Friday)
- 2nd Shift - 3:00 pm – 11:30 pm (Monday ‑ Friday)
- 3rd shift: 11:00 pm – 7:30 am (Sunday ‑ Thursday)
- 2nd shift Technicians are given the opportunity to receive an extra $2/hour worked on 2nd shift.
- 3rd shift Technicians are given the opportunity to receive an extra $3/hour worked on 3rd shift.
- Upon qualification in the above functions, Technicians will be given the opportunity to cross‑train in filling operations, formulation and component preparation, packaging operations, and inspection.
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.