Our client has an exciting opportunity for a Manufacturing Associate to join the Upstream/Cell Culture subdivision of the Manufacturing team. This is an exciting opportunity to work collaboratively in executing bioprocess operations primarily in Cell Culture/Upstream manufacturing and well as CIP/SIP operations (cleaning, assembly, sterilization, disassembly, operation of primary process equipment). The ideal candidate possesses strong computer and multi-tasking skills, strong verbal and written communication skills, and experience working in a fast-paced, dynamic environment with limited supervision.
Manufacturing Associate I-III Responsibilities
Executes bioprocess operations successfully primarily in Adjuvant manufacturing.
CIP/SIP operations: cleaning, assembly, sterilization, disassembly, and operation of primary process equipment.
Unit operations described in standard operating procedures and batch records (50%-100% of effort).
Performs manufacturing operations, including dispensing, solution preparation and tangential flow filtration.
Recommends and executes projects and changes to bioprocess operations to reduce risk and increase efficiency.
Completes required processing documentation including deviation reports, change control, product changeover, etc.
Identifies, creates and revises GMP documentation as required including MBRs.
Performs review of GMP documentation and participates in training and development opportunities to gain understanding of compliance requirements and departmental policies.
Participates in validation activities including IQ/OQ/PQ and process validation.
Assists in compliance and technical development projects.
Performs document revisions to Standard Operating Procedures.
Initial training and application of GMP regulations (ICH Q7A) as it applies to job function.
Other duties as assigned.
Manufacturing Associate I-III Qualifications
Bachelor’s Degree and/or 1-5+ years of relevant work experience.
Proven experience working in manufacturing operations.
Proven experience and knowledge in bioprocess operations such as solution compounding or tangential flow filtration.
Working knowledge in relevant math, science, and engineering disciplines.
Ability to Communicate, read, and write legibly in English, as well as possession of strong technical writing skills.
Ability to apply advanced computer skills including work with spreadsheets(Excel) and word processing (Word).
Ability to manage time effectively.
Detail oriented with ability to complete written and verbally assigned tasks following specific procedures.
Prior experience in aseptic processing and ability to apply excellent aseptic technique.
Working knowledge of GMP regulations (ICH Q7A), as well as experience with equipment and technology as it applies to job function.
Ability to interact constructively with peers and support groups, using organizational and communication skills necessary to plan and execute work flow.
Due to the nature of manufacturing, shifts can and will vary. Shift preference may not always be available upon request.
VanderHouwen is an award-winning, Women-Owned, WBENC certified professional staffing firm. Founded in 1987, VanderHouwen has been successfully placing experienced professionals throughout the Pacific Northwest and nationwide. Our recruitment teams are highly specialized in either Technology and IT, Engineering, or Accounting and Finance career markets. Our recruiters value building meaningful, professional relationships with each candidate as well as developing honed knowledge of companies' staffing needs and workplaces. Partner with us to land your next exciting career.
VanderHouwen is an Equal Opportunity Employer and participates in E-Verify. VanderHouwen does not discriminate on the basis of race, color, religion, sex, national origin, age, disability, or any other characteristic protected by applicable local, state or federal civil rights laws.