Manufacturing Associate

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Job Title: Manufacturing Associate
Location: Portsmouth, NH 03801
Duration: 12 Months
Job Type: Temporary Assignment
Shift: Night Shift
Work Type: Onsite

The Manufacturing Associate Level I is responsible for the manufacture of therapeutic proteins (API) under cGMP conditions. The role involves executing process recipes, following standard operating procedures (SOPs), monitoring equipment and processes, performing basic laboratory tasks such as pH, conductivity, and sampling, and conducting routine sanitization of facilities and equipment. Associates are expected to develop a basic understanding of cGMP compliance while working under close supervision and demonstrate aseptic techniques in handling products and materials.

Responsibilities

• Set up, operate, and monitor production equipment and processes, including Clean-in-Place (CIP) and Steam-in-Place (SIP) operations.
• Document production activities in written and electronic records in accordance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Review documentation as required.
• Attain qualification for all assigned tasks and maintain an individual training plan.
• Perform basic laboratory tasks, including monitoring pH, conductivity, and testing product samples.
• Perform material movements and transfer raw materials and chemicals into, out of, and across production areas.
• Maintain facilities and equipment through routine cleaning and sanitization and support 6S programs.
• Complete administrative tasks including attending shift exchanges, meetings, sending and receiving emails, and participating in projects.
• Perform other duties as assigned.
• Accurately complete timesheets.
• Contribute ideas for cost savings and properly handle equipment and materials to minimize damage and costs.
• Adhere to cGMP requirements during the manufacture of APIs.
• Take ownership of product quality and promptly notify management of regulatory inspections, GMP deficiencies, process deviations, product defects, and related actions.
• Follow all job safety procedures and attend required health and safety training.
• Promote workplace safety and promptly report actual or potential accidents and injuries.
• Comply with company and site safety policies and take responsibility for personal and team safety.

Required Skills

• High School Diploma or equivalent required.
• Associate's or Bachelor's degree in a science-related discipline preferred.
• Entry-level manufacturing experience (0 4 years).
• Basic understanding of cGMP, GMP, and GDP requirements.
• Ability to perform laboratory tasks including pH, conductivity, and product sampling.
• Ability to operate production equipment and support CIP and SIP operations.
• Proven logic, decision-making, and critical thinking skills.
• Strong written and verbal communication skills.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity.