Manufacturing Support Specialist III

The Support Specialist III plays a crucial role in supporting manufacturing operations with a strong focus on aseptic processing, GMP cleaning, and strict adherence to cGMP requirements. As a technical and procedural leader within GMP operations, this position involves performing complex aseptic processing activities, managing GMP workspaces, and ensuring consistent compliance with Standard Operating Procedures (SOPs). The role includes documenting processes, training staff, and participating in continuous improvement initiatives, requiring a high degree of independence, accountability, and attention to detail.

Responsibilities

• Perform complex aseptic processing of in-house solutions following current cGMP requirements, ensuring product sterility and quality.
• Prepare and verify material kits in alignment with cGMP and Good Documentation Practices (GDP).
• Execute and oversee cleaning and sanitization of GMP manufacturing areas and equipment using approved procedures and industry best practices.
• Maintain accurate and complete GMP documentation, including batch records, logbooks, and cleaning records.
• Support cleanroom operations, ensuring environmental conditions remain within established alert and action limits.
• Review, revise, and maintain SOPs, batch records, and manufacturing documentation to ensure regulatory compliance and operational accuracy.
• Ensure all GMP documentation is completed accurately, clearly, and in compliance with GDP standards.
• Participate in internal and external audits, including FDA inspections, by providing documentation and operational support.
• Support deviation investigations and CAPA activities, contributing to root cause analysis and implementation of corrective actions.
• Provide training, guidance, and mentorship to junior manufacturing support staff.

• Proficiency in aseptic technique, cleanroom and sterile processing.
• Knowledge of cell culture, cell biology, molecular biology, and GMP regulations.
• Experience in aseptic operations, laboratory procedures, decontamination, SOP development, medical device handling, environmental monitoring, troubleshooting, and batch record management.

• AS/BS in Biotechnology, Biology, Chemistry, or a related field preferred; a science-related discipline is advantageous.
• High School Diploma or equivalent may be considered with relevant experience.
• Certification in aseptic techniques or GMP training is preferred.
• 2-4 years of relevant experience in biotechnology manufacturing, GMP environments, or a related field.
• Experience with SOP revision, documentation control, and deviation/CAPA investigations is preferred.

The role is based in a lab and office setting, specifically within a cleanroom environment at level 10k and 100k. Responsibilities include sterile gowning, maintaining certification for sterile gowning, and working within the specified shifts of 7AM to 3PM or 10AM to 7PM, Monday to Friday.

Job Type & Location

This is a Contract to Hire position based out of Winston Salem, NC.

The pay range for this position is $32.00 - $34.00/hr.

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)

This is a fully onsite position in Winston Salem,NC.

This position is anticipated to close on May 19, 2026.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I is 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

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we’ve helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.