Aseptic Process Validation

Job Description

Job Description

LOCATION: On Site, Greenville, NC, USA

We are seeking a highly experienced Aseptic Process Validation Engineer / Specialist to support critical validation activities within a GMP-regulated pharmaceutical manufacturing environment. This is a full-time (40+ hour weekly) contract opportunity (3–6 months contract) for an independent contractor with proven experience in sterile and aseptic processing.

This role is focused on execution in the manufacturing environment, including media fills (APS), sterilization validation, environmental monitoring, and aseptic process validation activities. The ideal candidate brings deep technical expertise and is comfortable working directly on the floor to ensure processes consistently meet sterility and regulatory requirements.

This is not a documentation-only role — we are looking for someone who can actively support validation runs, troubleshoot in real time, and collaborate closely with Manufacturing, Quality, and Engineering teams.

Candidates with experience in Process Engineering or Cleaning Validation within pharmaceutical environments will also be considered.

Main Responsibilities:

• Execute aseptic process validation activities, includingmedia fills (Aseptic Process Simulations – APS)
• Support development, review, and execution of validation protocols and reports.
• Collaborate with Manufacturing and Quality teams during aseptic operations and validation runs.
• Review and support interpretation of environmental monitoring (EM) data, as applicableto validation activities.
• Ensure compliance with cGMP and regulatory requirements for sterile manufacturing.
• Participate in risk assessments related to aseptic processing and contamination control strategies.
• Analyze validation data to confirm process controland compliance with sterile manufacturing requirements.
• Troubleshoot issues during validation execution, including aseptic failures and deviations.
• Support deviation investigations, root cause analysis, and CAPA implementation.
• Collaborate with Manufacturing, Quality Assurance,Regulatoryand Engineering teamstosupportprocess performance and resolve deviations.
• Other relevant activities.

General Requirements:

• Strong technical writing and documentation skills.
• Ability to work 100% on-site (hands-on executionrequired).
• Experience with aseptic processing and media fill execution (APS)
• Solid understanding of FDA, EMA, andcGMPrequirements.
• Experience working in regulated pharmaceutical manufacturing environments.
• Proficiencyin Microsoft Office 365.
• Abilityto work independently and manage multiple priorities.

Education Requirements:

• Bachelor’s degree in Engineering, Life Sciences, or related technical discipline.
• Equivalentcombination of education and experience may be considered.

Experience Requirements:

• 5+ years of experience in process validationwithin pharmaceutical or consumer health manufacturing.

• Experience in asepticprocess validation is a plus.

• Hands-on experience withmedia fills (APS), sterile manufacturingenvironmentsand validation protocol execution
• Proven knowledge of cGMP, FDA, ICH, andotherregulatory requirements and guidance.

Physical Requirements:

• Ability to sit for extended periods of time.
• Ability to perform light physical activities as needed.
• Must be able to work in manufacturing and cleanroom environments.
• Ability to wear personal protective equipment (PPE) as required.
• Ability to perform in diverse industrial settings.