Validation Area Specialist - Finished Production

About the role

The Validation Area Specialist will provide/lead validation services required for the successful delivery of IT & Automation projects. They will report to the Senior Project Manager, Site Capacity & Upfit.

Responsibilities

• Provide validation & technical support through the preparation, execution, data analysis, & report writing for IV, OV & PV protocols
• Own 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
• 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

Qualifications

• Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
• Master's Degree preferred
• Minimum of seven (7) years validation or quality related discipline experience in pharmaceutical environment required
• 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 required
• Demonstrated experience using root-cause analysis techniques to solve problems preferred
• Ability to read, write & understand complicated product documentation preferred
• Strong 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 preferred
• Ability to write technical documentation based on equipment manuals preferred
• Experience in pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferred
• Knowledge of standard operating procedures with attention to high-level concepts preferred
• Strong skills in change management within Novo Nordisk preferred