Job Description

Qualifications

• Bachelor's Degree in Engineering or related field
• 7+ years validation or quality related discipline experience in pharmaceutical environment
• Experienced with regulatory requirements & industry standards for pharmaceutical &/or medical device manufacture, such as 21 CFR Part 11, GAMP5, ISO, electronic records retention, configuration items list, FDA & ICH guidance documents
• Demonstrated experience using root-cause analysis techniques to solve problems
• Ability to read, write & understand complicated product documentation
• Demonstrated leadership & project management skills: two-way communication skills with customers (internal/external), project team & management; interpersonal & team building skills; achievement of project timelines & customer requirements
• Ability to write technical documentation based on equipment manuals
• Experience in pharmaceutical manufacturing is preferred. Knowledgeable in GMP concepts
• Knowledge of standard operating procedures with attention to high-level concepts
• Ability to manage multiple tasks/deadlines & prioritize properly based on process needs
• Demonstrated strong skills in change management within NN

Pluses:

• Master's Degree in related field
• 3-5 years’ minimum experience with robotics, automation and SAP

Job Description:

We are seeking an experienced Validation Specialist to support a pharmaceutical client in the Raleigh area. This person’s primary responsibility will be to provide and lead validation services required for the successful delivery of highly automated warehouse processes and projects.

Responsibilities:

• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols.
• Ownership of Change Requests (CR’s) related to project validation responsibilities.
• Perform compliance & technical reviews/approvals of protocols & protocol data.
• Author project quality masterplans (PQMP’s), validation plans (VPL’s), & other key validation documentation. Author & execute assigned IV, OV & PV protocols for direct impact systems/processes per approved timeframes. Requires no guidance & direction to complete these goals & needs no coaching on technical competencies for goal obtainment. Serves as a source of expertise in the group for validating new systems.
• Ensure compliance of validation protocols executed are aligned with local, corporate & regulatory regulations.
• Lead validation failure investigations & non-conformities utilizing root cause analysis techniques.
• Create & modify existing validation procedures & configuration item lists (CIL’s) as required.
• Write/Review specifications, procedures, & other required supporting documents to maintain the validated state of equipment & processes.
• Participate in FAT, SAT commissioning efforts for equipment, automation systems & processes & successfully transition into the ownership role for validation efforts related to the equipment.
• Identify process improvements before equipment, systems or processes are placed under change control during validation.
• Budget oversight as needed.
• Contractor scheduling & oversight as needed.
• Leads validation activities assigned by overall project manager.
• Other accountabilities, as assigned.

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