Manufacturing Associate

TekWissen • Plainville, MA

4d • Onsite

About The Position

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands. This position requires executing manufacturing work instructions and completing assigned tasks while spending approximately 90% of working time in manufacturing suites. The role operates in a dynamic GMP/cGMP environment, demanding high standards of safety and quality, and ensuring accurate documentation and cleanroom compliance.

Requirements

• A high school diploma or equivalent is required.
• A minimum of 1 year of experience in manufacturing, operations, production, laboratory, or a related field.
• Technical expertise in biopharmaceutical manufacturing equipment, principles, and processes.
• Strong understanding of current GMP and safety standards.
• Ability to function effectively in a dynamic environment and balance multiple priorities.
• Ability to learn and use new software and tools.
• Ability to make decisions regarding moderately complex GMP manufacturing activities with minimal to moderate supervision.
• Ability to recognize situations requiring further evaluation and report them to senior operators or management.
• Effective written and verbal communication skills with peers, senior associates, and area management.
• Understanding of GMP operational documentation, including accuracy and completeness.
• Ability to perform aseptic and/or sterile gowning as required.
• Ability to read, write, and review documentation for extended periods.
• Ability to safely work with or around dry ice, liquid nitrogen/cryogenic materials, hazardous agents, and infectious agents.
• Ability to work in environments with significant temperature changes.
• Ability to wear required PPE and comply with GMP/cleanroom regulations.
• Ability to meet physical requirements, including prolonged sitting and standing, lifting, walking, reaching, stooping, kneeling, and crouching.
• Ability to meet required visual standards, including close, distance, color, peripheral, and depth perception and the ability to adjust focus.
• Ability to talk and hear effectively during work activities.
• Ability to comply with workplace requirements such as closed-toe shoes and cleanroom restrictions on piercings and nail polish.

Nice To Haves

• Experience in a cGMP environment is preferred.

Responsibilities

• Execute manufacturing work instructions and complete assigned tasks.
• Achieve full training status and assist in training staff.
• Perform semi-routine assignments and receive instruction on new processes.
• Maintain inventory records and accurate batch records.
• Inspect finished products for adherence to specifications.
• Assist with batch record reconciliation and preventative maintenance tasks.
• Follow Quality Management Systems (QMS).
• Assist with Nonconformance/CAPA closures.
• Identify and communicate issues requiring escalation.
• Maintain a clean and safe work environment.
• Follow company policies regarding safety, training, GDP, GMP, and cleanroom gowning.
• Spend approximately 90% of work time in manufacturing suites.
• Perform activities safely to prevent product releases, accidents, and injuries.
• Use computers and manufacturing systems daily.

What This Job Offers

• Career Level: Entry Level
• Education Level: High school or GED