Validation Area Specialist Position Available In Johnston, North Carolina
Tallo's Job Summary: The Validation Area Specialist I at Intellyk in Clayton, NC is responsible for revalidating equipment and processes in Aseptic Production. Key responsibilities include performing and reviewing revalidation activities, authoring and reviewing validation documents, and collaborating on protocols. The job requires a Bachelor's degree and 2 years of validation experience in pharmaceutical or medical devices, with a contract pay of $23.32 - $27.00 per hour.
Job Description
Validation Area Specialist Intellyk Clayton, NC 27520 The Validation Area Specialist I is responsible for performing revalidation activities for equipment and processes within Aseptic Production (AP), including formulation, sterilization, cleaning, filling, and inspection. This role supports both new and existing systems and ensures validation activities meet regulatory expectations.
Key Responsibilities:
Perform and review revalidation activities in alignment with approved timelines and regulatory requirements. Author and review validation documents such as protocols, procedures, and specifications. Support or lead investigation closures using root cause analysis and implement corrective actions. Collaborate on IQ, OQ, and PQ protocols for systems and processes. Review protocol data to ensure accuracy and compliance with acceptance criteria.
Qualifications :
Bachelor’s degree in Engineering, Computer Science, or a relevant scientific or technical field. Minimum 2 years of experience in validation within the pharmaceutical or medical device industry. Knowledge of cGMP documentation and compliance practices.
Job Type:
Contract Pay:
$23.32 – $27.00 per hour
Schedule:
8 hour shift Day shift Application Question(s): W2
Only Experience:
- Perform and review revalidation activities: 3 years (Required)
- Author and review validation documents: 3 years (Required)
- Support or lead investigation closures: 2 years (Required) validation within the pharmaceutical or medical device: 4 years (Required) Ability to
Commute:
Clayton, NC 27520 (Required)
Work Location:
In person
