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**Job Title:** MSAT Engineer

**Department:** Regulatory / Manufacturing Science and Technology (MSAT)

**Location:** Winston-Salem, NC

**Job Type:** Full-time, Exempt

**Salary:** $100,000-$120,000/year

Position Summary:

The MSAT Engineer plays a key role in supporting technology transfer and ongoing process performance within a GMP-regulated manufacturing environment. This position acts as a technical owner for critical process deliverables—including Bills of Materials (BoM), process flow diagrams, process descriptions, and equipment lists—and ensures that manufacturing operations are compliant, efficient, and robust. The MSAT Engineer will collaborate closely with Manufacturing, Quality Assurance, Validation, and Regulatory teams to enable successful production, technical investigations, and continuous improvement initiatives.

Key Responsibilities:

+ Lead and support material qualification activities, including technical assessments, documentation, and implementation to ensure materials meet quality and process standards.

+ Contribute to technology transfer activities by drafting and reviewing technical reports, protocols, and SOPs.

+ Own and maintain process documentation such as BoMs, process flow diagrams, process descriptions, and equipment lists throughout the product lifecycle.

+ Generate and analyze Process Performance Reports to monitor process control and identify opportunities for optimization.

+ Conduct technical studies and investigations to resolve deviations, support CAPA development, and implement process improvements.

+ Collaborate cross-functionally with QA, Manufacturing, Validation, and Regulatory to support audits, investigations, and regulatory commitments.

+ Support and document change control activities related to processes, equipment, and materials.

Qualifications:

+ Bachelor’s or Master’s degree in Chemical Engineering, Biotechnology, Life Sciences, or a related discipline.

+ Minimum of 5 years’ experience in pharmaceutical, biotechnology, or cell therapy manufacturing within a GMP environment.

+ Experience with digital manufacturing systems (e.g., MES, EBR) preferred.

+ Proven experience with process documentation, technical ownership, and process deliverables.

+ Familiarity with technology transfer and material qualification processes.

+ Strong understanding of GMP manufacturing unit operations and regulatory requirements (FDA, EMA, ICH).

+ Excellent technical writing, documentation, and communication skills.

+ Experience supporting or preparing **regulatory filings** (e.g., IND, BLA).

+ Knowledge of **GMP regulations** and regulatory expectations in the cell therapy space.

+ Proficiency with data analysis tools such as **JMP** , **Minitab** , or equivalent.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.