Manufacturing Associate

TekWissen LLC; Plainville (MA); On-site; USD 30,000 - 47,000; Full time

Job summary

TekWissen Group is seeking a Manufacturing Associate for a 12-month onsite assignment in Plainville, MA. The role performs routine and moderately complex formulation and manufacturing activities in a cGMP biopharmaceutical facility, supporting day-to-day operations in the Viral Vector Services division of the client.

You will maintain accurate batch records, follow GMP and GDP guidelines, and participate in training while working primarily in manufacturing suites.

Qualifications

• Experience in cGMP biopharmaceutical manufacturing.
• Ability to read, write, and complete GMP documentation.
• Knowledge of aseptic and/or sterile gowning.
• Strong attention to detail and safety.
• Ability to work in a fast-paced manufacturing environment.

Responsibilities

• Execute work instructions and complete manufacturing/formulation activities.
• Perform routine and semi-routine manufacturing operations.
• Maintain accurate batch records and inventory records.
• Follow Quality Management Systems and support CAPA closure activities.
• Identify issues requiring escalation and communicate to supervision.
• Spend approximately 90% of time in manufacturing suites.
• Use computer systems and manufacturing software daily.
• Work safely with materials and PPE.

Skills

Biopharma manufacturing

GMP knowledge

Documentation

Problem solving

Communication

Aseptic gowning

PPE safety

Teamwork

Independent work

Safety compliance

Job description

Overview

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.

Position: Manufacturing Associate
Location: Plainville MA 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite

Summary

The Manufacturing Associate is a technical manufacturing professional responsible for performing routine and moderately complex formulation and manufacturing activities in a cGMP-compliant biopharmaceutical facility. The role supports day-to-day manufacturing operations, documentation, quality compliance, troubleshooting, and training while working primarily in manufacturing suites. The position contributes to the production of innovative gene therapy products within Client's Viral Vector Services (VVS) division.

Responsibilities

• Execute work instructions and complete assigned manufacturing/formulation activities.
• Perform routine and semi-routine manufacturing operations with minimal to moderate supervision.
• Handle moderately complex tasks within the scope of training and experience.
• Achieve full training status and assist in training other staff.
• Maintain accurate inventory records and batch records.
• Inspect finished products for compliance with specifications.
• Assist with batch record reconciliation and preventative maintenance activities.
• Follow Quality Management Systems and support Nonconformance/CAPA closure activities.
• Identify issues requiring escalation and communicate them to senior operators or management.
• Maintain a clean, safe, and compliant manufacturing environment.
• Follow company requirements for GMP, GDP, safety, training, cleanroom gowning, and PPE.
• Perform activities safely to prevent product releases, accidents, and injuries.
• Spend approximately 90% of working time in manufacturing suites.
• Use computer systems and manufacturing software on a daily basis.
• Work safely with materials and conditions that may include dry ice, liquid nitrogen/cryogenics, hazardous materials, and infectious agents.

Required Skills

• Knowledge of biopharmaceutical manufacturing equipment, processes, and principles.
• Strong understanding of current GMP/cGMP and safety standards.
• Ability to perform manufacturing activities independently with minimal to moderate supervision.
• Ability to make decisions during moderately complex GMP manufacturing activities.
• Strong problem-solving and troubleshooting abilities.
• Ability to recognize situations requiring further evaluation and elevate appropriately.
• Strong written and verbal communication skills.
• Ability to accurately read, write, review, and complete GMP documentation and batch records.
• Understanding of GMP operational documentation, accuracy, and completeness requirements.
• Ability to balance multiple priorities in a dynamic manufacturing environment.
• Ability to quickly learn new software, systems, and manufacturing tools.
• Knowledge or ability to perform aseptic and/or sterile gowning as required.
• Ability to work effectively with peers, senior associates, and management.
• Strong attention to detail and commitment to quality and safety.
• Ability to safely work in controlled manufacturing environments while wearing required PPE.

TekWissen Group is an equal opportunity employer supporting workforce diversity.