The PositionPrimary responsibility is to provide/lead validation services required for the successful delivery of IT & Automation projects.
RelationshipsReports to Senior Project Manager, Site Capacity & Upfit.
Essential Functions- 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
Physical RequirementsMay move equipment &/or supplies weighing up to 33 pounds within the facility using various body positions. May be required to be on your feet for up to a 12-hour shift. May required corrected vision to 20/20 or 20/25 based on role. May require color vision based on role. May require the ability to work in loud noise environments with hearing protections.
Qualifications- Bachelor's Degree in Engineering, Computer Science, or applicable technical degree or proven equivalent relevant work experience required
- Master's Degree preferred 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
- 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 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
- Ability to manage multiple tasks/deadlines & prioritize properly based on process needs preferred
- Demonstrated strong skills in change management within NN preferred
