Manufacturing Support Associate I/II

12-hour rotating shift: 7:00 AM – 7:00 PM on a 2-2-3 schedule.

About the role

This position is an entry-level role in cGMP manufacturing, performing routine and non-routine cleanings of GMP facilities, managing process waste, and supporting manufacturing operations. Aseptic and gowning qualifications are required.

Responsibilities

• Perform and maintain manufacturing facilities through routine and non-routine cleanings.
• Clean, operate, and maintain the process waste area, ensuring cleanliness and proper disposal of waste materials.
• Clean drums and dollies as required.
• Prepare, build, and complete processing assemblies (PAR) for production.
• Complete facilities response forms and communicate with other departments for EM sampling if required.
• Stock general supplies in manufacturing production areas.
• Handle and discard hazardous and non-hazardous waste.
• Document and maintain records to comply with regulatory requirements, cGMPs, policy documents, and SOPs.

Requirements

• Manufacturing Support Associate I: High School Diploma or Associate Degree with 0+ years of experience.
• Manufacturing Support Associate II: High School Diploma or Associate Degree with 2+ years of experience.
• Ability to read, interpret, and write English documents such as safety rules, SOPs, and procedure manuals.
• Ability to communicate effectively with coworkers and supervisors.
• Ability to apply common sense understanding to carry out instructions in written, oral, or diagram form.
• Ability to solve problems involving several concrete variables in standardized situations.
• Basic math skills: addition, subtraction, multiplication, division, ratios, and percentages.
• Must be able to stand, walk, wear steel-toe shoes, and perform physical tasks such as pushing, pulling, squatting, lifting, reaching, and carrying waste (within job-specific limits).
• Must maintain facial hair short enough to ensure a proper seal for respirator use (full-faced and half-faced respirators required due to Spor-Klenz exposure).

Skills

• Proficiency in Microsoft Word, Excel, and email.
• Experience using computers, telephones, copy machines, and fax machines.

Working Conditions

• 12-hour shifts, including potential overnight work.
• Work in a cGMP manufacturing biotechnology facility requiring cleanroom operations and adherence to personal hygiene standards.
• Exposure to mechanical, chemical, and electrical hazards, as well as tripping and falling risks.
• Moderate to high noise levels in the work environment.