Location: Clayton, NC
Schedule: Monday–Friday, 1st Shift
Duration: 1 Year with potential for extension
Reporting Expectations: 100% On-Site

About the Role:

We are seeking a Validation Area Specialist (Aseptic Production) to join our client’s team in Clayton, NC. This is a critical role supporting equipment and process revalidations for aseptic manufacturing operations including formulation, sterilization, cleaning, filling, and inspection. The ideal candidate will be hands-on, flexible with scheduling in a 24/7 environment, and capable of handling both the physical and documentation aspects of validation activities.

Key Responsibilities:

• Perform and review equipment/process revalidations in alignment with approved timelines.
• Author and review validation protocols, procedures, and quality documents in compliance with regulatory and corporate standards.
• Collaborate with cross-functional teams to schedule and execute revalidations.
• Lead and support investigations using root cause analysis techniques and implement corrective actions.
• Participate in continuous improvement initiatives using cLEAN tools and methodology.
• Review executed protocol data to ensure accuracy and adherence to acceptance criteria.
• Manage Change Requests (CRs) related to revalidation activities.
• Support audits and inspections by presenting validation concepts and documentation.
• Adhere to all safety, environmental, and company procedures.

Top Skills Required:

1. Equipment revalidation experience
2. Schedule flexibility (site operates 24/7)
3. Ability to perform both physical revalidations and associated paperwork

Required Qualifications:

• Bachelor’s Degree in Engineering, Computer Science, or a related scientific/technical field.
• Minimum of 2 years of validation experience in pharmaceutical or medical device industry.
• Experience with cGMP documentation and regulatory requirements.
• Strong oral and written communication skills.

Preferred Qualifications:

• Background in core validation areas (sterilization, cleaning, process or computer validation).
• Familiarity with Microsoft Office Suite and statistical methods.
• Experience with validation test equipment, such as Kaye Validators.
• Demonstrated use of root-cause analysis for problem solving.
• Proven ability to work collaboratively in project teams.