Job Description
Provide manufacturing operations support including the formulation and aseptic filling of Cryopreservation media, cell culture media, and cell culture supplements. Execute and maintain documentation relating to manufacturing procedures, ensuring compliance with applicable regulations and industry standards (e.g. FDA 21CFR, cGMP, ISO13485). Support all technical writing requirements for manufacturing/operations, authoring and revising manufacturing batch records, SOPs, work instructions, validation/qualification protocols, forms, logbooks, technical reports, CAPAs, change controls, and other relevant documents.
ResponsibilitiesFormulate, fill, and finish manufactured products, including cryopreservation media, cell culture media, and supplements.Perform aseptic processes in a controlled or cleanroom environment.Conduct in-process testing of products using general laboratory equipment/instrumentation.Utilize formulas and work instructions to monitor the production process.Perform experiments associated with development, improvement, 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.Maintain current knowledge of developments related to product recovery and purification processes.Evaluate, troubleshoot, and solve routine problems, interpreting data based on knowledge and experience.Perform process validation and equipment qualification as required.Perform general equipment preventive maintenance and 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.Essential Skills2 years minimum relevant experience.Detail-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 other software programs.Strong adherence to cGMPs, regulatory compliance, safety requirements, SOPs, and other related documents such as SDS and manuals.Additional Skills & QualificationsBS or MS in Biology, Chemistry, Bioengineering, or a related field.2 years minimum experience working in a life science manufacturing role.Work Environment
Will be working in a lab setting as part of a team. Monday to Friday, 9am to 5pm, with a 1-hour lunch break.
Pay and Benefits
The pay range for this position is $25.00 - $27.00
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in BOCA RATON,FL.
Application Deadline
This position will be accepting applications until Jan 17, 2025.
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 & InclusionAt 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 peopleThe 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.