Process Validation Engineer

Creative Solutions Services, LLC; Durham (NC); On-site; USD 110,000 - 160,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Process Validation Engineer to support GMP pharmaceutical manufacturing initiatives. The role involves developing, executing, and documenting validation studies while partnering with Manufacturing, Quality, Engineering, and Microbiology teams.

Initial focus on planning and protocol generation, then hands-on execution of mixing and microbial hold studies as projects progress.

Qualifications

• 5-7+ years of pharmaceutical or biotech process validation experience including mixing studies and microbial hold studies.
• Proficient in protocol authoring, execution, and data analysis in GMP manufacturing.
• Ability to independently execute studies, troubleshoot on the manufacturing floor, and make technical decisions.

Responsibilities

• Develop, review, and execute process validation protocols, reports, and GMP documentation.
• Lead mixing studies, microbial hold studies, and other validation activities across the lifecycle.
• Perform statistical analysis and prepare technical summaries and validation reports.
• Support cleaning validation, SIP/CIP, thermal validation, and related qualification activities.
• Collaborate with Manufacturing, Engineering, Quality, and Microbiology teams to meet timelines.
• Provide hands-on validation execution and real-time troubleshooting on the floor.

Skills

Process Validation

Mixing studies

Microbial hold studies

Statistical data analysis

Protocol authoring/execution

Independent study execution

GMP manufacturing

Minitab

ValGenesis

KNEAT

Tools

Minitab

ValGenesis

KNEAT

SIP/CIP

Job description

Job Description:

• Our client is seeking a Process Validation Engineer to support activities within a GMP pharmaceutical manufacturing environment.
• This individual will be responsible for developing, executing, and documenting process validation studies while partnering closely with Manufacturing, Quality, Engineering, Microbiology, and other cross-functional teams.
• The role will initially focus on validation planning, protocol generation, and documentation before transitioning into hands‑on execution of mixing studies, microbial hold studies, and other process validation activities as the project progresses.
• The ideal candidate is a self‑sufficient validation professional who can independently execute studies, analyze data, troubleshoot issues on the manufacturing floor, and make sound technical decisions with minimal oversight.
• This is a full‑time onsite consulting opportunity supporting a large‑scale manufacturing startup.

Key Responsibilities:

• Develop, review, and execute process validation protocols, reports, and supporting GMP documentation.
• Lead and support mixing studies, microbial hold studies, and other process validation activities throughout the validation lifecycle.
• Perform statistical analysis of validation data and prepare technical summaries and validation reports.
• Support cleaning validation, SIP/CIP, thermal validation, and related qualification activities as needed.
• Collaborate with Manufacturing, Engineering, Quality, and Microbiology teams to execute studies, resolve deviations, and maintain project timelines.
• Provide hands‑on support during validation execution, making real‑time technical decisions and troubleshooting issues in the manufacturing environment.

Must Have Skills:

• 5-7+ years of experience within pharmaceutical or biotechnology Process Validation experience, mixing studies, microbial hold studies, protocol authoring/execution, statistical data analysis, and independent study execution within a GMP manufacturing environment.

Focus On exp:

• Experience with KNEAT trade off systems exp would be ValGenesis, cleaning validation, SIP/CIP, thermal validation, biologics manufacturing, PPQ/CPV, Minitab, or facility startup projects.