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Manufacturing Associate

TekWissen LLC

Portsmouth, NH

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JOB DETAILS
SALARY
$20–$26
SKILLS
Administrative Skills, Agriculture, Application Programming Interface (API), Asepsis, Biology, Biotech and Pharmaceutical, CIP (Clean-in-Place), Cleanroom, Communication Skills, Computer Skills, Current Good Manufacturing Practice (cGMP), Customer Support/Service, Detail Oriented, Disease, Diversity, Documentation, GMP (Good Manufacturing Practices), Gene Therapy, High School Diploma, Laboratory Testing, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Equipment Maintenance, Manufacturing/Industrial Processes, Material Moving, Material Science, Medical Products, Multitasking, Nutrition, Operations Processes, Personal Care, Product Testing, Production Support, Production Systems, Record Keeping, SIP (Session Initiation Protocol), Standard Operating Procedures (SOP), Team Player, Testing, Workforce Management
LOCATION
Portsmouth, NH
POSTED
8 days ago
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 to 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
Work Type: Onsite
Shift: NightShift from 07:00 PM to 07:00 AM (12 hours) - Rotating Shift
Job Summary
The Biotechnologist Associate / Manufacturing Associate is responsible for the manufacturing of therapeutic proteins (API) under cGMP conditions. This role involves executing process recipes, operating and monitoring manufacturing equipment, performing basic laboratory testing, maintaining facility and equipment cleanliness, and ensuring compliance with GMP and GDP requirements. The associate is expected to develop proficiency in aseptic techniques, follow standard operating procedures (SOPs), and support production activities in a cleanroom environment under close supervision.

Responsibilities
  • Manufacture therapeutic proteins (API) in accordance with cGMP requirements.
  • Execute process recipes and follow established SOPs and batch records.
  • Set up, operate, and monitor manufacturing equipment and production processes.
  • Perform Clean-in-Place (CIP) and Steam-in-Place (SIP) operations.
  • Complete production documentation in written and electronic systems following GMP and GDP standards.
  • Review manufacturing documentation as required.
  • Perform basic laboratory testing, including, pH monitoring, Conductivity measurements and Product sampling and testing
  • Transfer and move raw materials, chemicals, and production materials within manufacturing areas.
  • Conduct routine cleaning and sanitization of equipment and facilities.
  • Support 6S and continuous workplace organization initiatives.
  • Attain qualification for assigned manufacturing tasks and maintain training records.
  • Demonstrate aseptic techniques while handling materials and products.
  • Work in a gowning-required cleanroom environment.
  • Attend shift handovers, team meetings, and project-related activities.
  • Manage routine administrative tasks, including email communication.
  • Perform other duties as assigned.
Required Skills
  • High School Diploma or equivalent experience is required
  • Recent graduates from Associates or Bachelors degree from Science related field will also be considered.
  • Prior work experience in a cleanroom, laboratory, or another sterile setting is preferred.
  • Prior experience with Aseptic Techniques and gowning procedures is preferred.
  • Working experience in manufacturing; cGMP setting preferred.
  • Basic understanding of cGMP, GMP, and GDP requirements.
  • Ability to follow SOPs, batch records, and manufacturing procedures accurately.
  • Knowledge of biopharmaceutical or API manufacturing processes.
  • Experience operating manufacturing equipment and production systems.
  • Familiarity with CIP (Clean-in-Place) and SIP (Steam-in-Place) processes.
  • Basic laboratory skills, including pH, conductivity, and sampling techniques.
  • Understanding of aseptic processing and contamination control practices.
  • Strong documentation and record-keeping skills.
  • Ability to work effectively in a cleanroom environment and follow gowning procedures.
  • Good communication and teamwork skills.
  • Ability to manage multiple tasks and follow training requirements.
  • Basic computer skills for electronic documentation and email communication.
  • Attention to detail and commitment to quality and compliance.
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/