Sterile Manufacturing Technician

TekWissen LLC

Plainville, MA

JOB DETAILS
SALARY
$20–$26
SKILLS
Asepsis, Autoclave, Biology, Biotech and Pharmaceutical, Change Control, Cleanroom, Communication Skills, Continuous Improvement, Corrective Action, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Quality, Diversity, Documentation, Drug Manufacturing, Equipment Validation, GMP (Good Manufacturing Practices), Healthcare, Identify Issues, Laboratory Equipment, Leading Edge Technology, Lift/Move 25 Pounds, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Manufacturing/Industrial Processes, Operational Strategy, Operational Support, Presentation/Verbal Skills, Problem Solving Skills, Product Development, Production Support, Purchasing/Procurement, Quality Management, Quality Metrics, Regulatory Compliance, Safety Training, Safety/Work Safety, Scientific Research, Workforce Management, Writing Skills
LOCATION
Plainville, MA
POSTED
7 days ago
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients worldwide. The job opportunity is for one of our clients specializing in biotechnology product development services. Our client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As the global leader in serving the field of science, our client boasts an annual revenue of around $40 billion with a mission to empower customers to make the world healthier, cleaner, and safer. Our client's global team is committed to delivering an unparalleled blend of cutting-edge technologies, convenient procurement options, and pharmaceutical services under their industry-leading brands.
Position: Sterile Manufacturing Technician
Location: Plainville, MA - 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Day Shift
Training Schedule: Monday Friday, 7:00 AM 3:30 PM (approximately 2 3 months)
Post-Training Schedule: 2-2-3 shift, 7:00 AM 7:00 PM (12-hour shifts)
Summary
This is a Formulation Technician II / Sterile Manufacturing Technician to support the site. This client site in Plainville, MA supports sterile pharmaceutical manufacturing operations, including formulation, filtration, aseptic processing, visual inspection, and other GMP-regulated activities. This role is responsible for independently performing sterile manufacturing operations while ensuring compliance with cGMP regulations, quality standards, and safety requirements. The ideal candidate will have hands-on GMP manufacturing experience and the ability to work in a fast-paced, highly regulated environment.
Responsibilities
  • Perform sterile manufacturing operations, including formulation, filtration, and aseptic filling.
  • Handle materials, perform line clearance, prepare equipment, and support manufacturing operations.
  • Operate, monitor, and troubleshoot manufacturing equipment and automated systems.
  • Execute weight and dispense activities, solution preparation, autoclave operations, visual inspections, and material transactions.
  • Ensure compliance with cGMP regulations, Good Documentation Practices (GDP), and data integrity standards.
  • Monitor manufacturing processes and identify opportunities to improve safety, quality, and operational efficiency.
  • Support investigations, deviations, change controls, and corrective and preventive actions (CAPA).
  • Assist with equipment qualification, validation, and continuous improvement initiatives.
  • Cross-train across multiple manufacturing functions to support production needs.
  • Maintain a safe and compliant work environment while following all site procedures and PPE requirements.
Required Skills:
  • Associate's or Bachelor's degree in Life Sciences, Engineering, or a related field preferred.
  • Relevant GMP manufacturing experience may be considered in place of a degree.
  • Minimum 2 years of GMP manufacturing or related technical experience.
  • Experience working in sterile manufacturing or pharmaceutical production is preferred.
  • Working knowledge of cGMP manufacturing operations.
  • Experience operating and troubleshooting manufacturing equipment.
  • Familiarity with sterile manufacturing processes, including formulation, filtration, and aseptic filling.
  • Strong documentation skills with knowledge of Good Documentation Practices (GDP).
  • Excellent problem-solving and troubleshooting abilities.
  • Ability to work across multiple manufacturing processes and adapt to changing production priorities.
  • Strong verbal and written communication skills.
  • Ability to work in cleanroom environments while following gowning and PPE requirements.
  • Ability to stand, walk, bend frequently, and occasionally lift up to 25 lbs.
  • Willingness to work non-standard hours as required.
TekWissen Group is an equal opportunity employer supporting workforce diversity.

About the Company

T

TekWissen LLC

WE THE TEKWISSEN PEOPLE

TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.

To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.

Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.

It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.

Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.



COMPANY SIZE
100 to 499 employees
INDUSTRY
Computer/IT Services
FOUNDED
2009
WEBSITE
http://www.tekwissen.com/