Manufacturing Specialist

4 weeks ago

WinstonSalem, United States Actalent Full time
Job DescriptionJob DescriptionJob Title: Manufacturing Specialist

Job Description

Currently seeking a lab technician responsible for supporting manufacturing processes, operating various process equipment, and documenting daily manufacturing operations in a cGMP environment. The candidate will produce products by setting up, cleaning, and following aseptic procedures.

Responsibilities
  • Participate in the aseptic processing of in-house made solutions as well as all patient processes according to cGMPs.
  • Read, understand, and follow Standard Operating Procedures (SOPs).
  • Set up and operate production equipment, such as control rate freezer and orbital shaker.
  • Assist in deviation and CAPA investigations, compiling data/information related to internal investigations as required.
  • Revise approved documents including SOPs, batch records, and MS forms as required.
  • Perform routine transactions with the ERP system, including material requisitions and production tracking.
  • Complete GMP documentation, including batch records, logbooks, and forms according to GDP guidelines.
  • Maintain the clean room environment by following established procedures to keep it below alert level limits.
Essential Skills
  • Experience in aseptic techniques.
  • Familiarity with cGMP environments.
  • Ability to read and follow SOPs.
  • Experience operating lab equipment such as control rate freezer and orbital shaker.
  • Experience in GMP documentation, including batch records and logbooks.
  • Capability to perform routine ERP system transactions.
Additional Skills & Qualifications
  • AS/BS in a science field (life sciences preferred).
  • 2-5 years GMP experience (can be from industries outside of pharma) or BioWorks certification preferred.
  • Cleanroom experience preferred.
  • 1-3 years of prior lab experience preferred.
  • Experience following SOPs and executing batch records.
Work Environment

The role will be based in both lab and office settings. The lab environment includes cleanrooms classified as level 10k and 100k, requiring sterile gowning and maintaining certification for sterile gowning. The position involves working in shifts: Shift 1: Sunday-Tuesday 7 AM-6 PM, Wednesday 7 AM-2 PM or Shift 2: Wednesday 11 AM-6 PM, Thursday-Saturday 7 AM-6 PM.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

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