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Description:
• Provide manufacturing operations support including the formulation and aseptic filling of Cryopreservation media, cell culture media, and cell culture supplements. Executes and maintains documentation relating to manufacturing procedures. compliance with applicable regulations and industry standards (e.g. FDA 21CFR, cGMP, ISO13485).
• Supports all technical writing requirements for manufacturing/operations.
• Author and revise manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls and any other document that may apply.
• Formulate, fill and finish manufactured products, including cryopreservation media, cell culture media, and supplements.
• Perform aseptic processes in a controlled or cleanroom environment.
• Perform in-process testing of products using general laboratory equipment/instrumentation.
• Utilizes formulas, work instructions or equivalent to monitor the production process.
• Perform experiments associated with development, improvement and scaling up or optimization of manufacturing and development processes.
• Troubleshoot problems associated with equipment, process development/production/ including data analysis and internal record keeping.
• Perform Environmental Monitoring activities as required.
• Perform the cleanzone cleaning as required.
• Maintains current knowledge of developments related to product recovery and purification processes.
• Performs duties in accordance with established laboratory standards.
• Evaluate, troubleshoot and solve routine problems. Interprets data based on knowledge and experience.
• Perform process validation and equipment qualification as required.
• Perform general equipment preventive maintenance. Contribute to maintaining lab and equipment cleanliness.
• Support and coordinate deviation investigations and implementation of change controls or robust corrective and preventative actions.
• Support finished product labeling, raw material aliquoting and, re-labeling requirements when necessary.
Skills & Qualifications:
• 2 years minimum relevant experience in a lab / biotech environment.
• Detailed oriented with good time management and organizational skills.
• Ability to work well under pressure and prioritize assignments in a multi-task position.
• Motivated and able to work independently.
• Excellent verbal communication skills and people/customer service oriented.
• Basic knowledge of Outlook, Word, Excel, and Software Programs.
• Requires a strong adherence to cGMPs, regulatory compliance and safety requirements, SOPs and other related documents such as SDS and manuals.
• BS or MS in Biology, Chemistry, Bioengineering or a related field 2 years minimum experience working in a life science manufacturing role
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.
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
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.
Other
$46k-63k (estimate)
05/12/2024
05/25/2024
The job skills required for Manufacturing / Lab Technician include SOP, Customer Service, Initiative, Time Management, Verbal Communication, etc. Having related job skills and expertise will give you an advantage when applying to be a Manufacturing / Lab Technician. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manufacturing / Lab Technician. Select any job title you are interested in and start to search job requirements.
The following is the career advancement route for Manufacturing / Lab Technician positions, which can be used as a reference in future career path planning. As a Manufacturing / Lab Technician, it can be promoted into senior positions as a Manufacturing Technician III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing / Lab Technician. You can explore the career advancement for a Manufacturing / Lab Technician below and select your interested title to get hiring information.