What are the responsibilities and job description for the Validation Area Specialist I position at Advanced Clinical?
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
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.
- Equipment revalidation experience
- Schedule flexibility (site operates 24/7)
- Ability to perform both physical revalidations and associated paperwork
- 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.
- 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.
