IT / OT Validation Lead - Remote

Descripción de la oferta

IT/OT Validation Activities

Leads validation IT/ OT validation activities as assigned
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
Other accountabilities, as assigned
Required Knowledge and Experience:

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 either life science, med tech or 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 med-tech / pharmaceutical manufacturing preferred. Knowledgeable in GMP concepts preferred
Knowledge of standard operating procedures with attention to high-level concepts preferred
Knowledge of QMS systems and best practice approaches
Ability to manage multiple tasks/deadlines & prioritize properly based on process needs preferred

Requerimientos

• Educación mínima: Universidad / Carrera Profesional
• 7 años de experiencia
• Idiomas: Inglés

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Hace 18 horas (actualizada)

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