IT / Ot Validation Lead

hace 3 meses

Bogotá Cundinamarca, Colombia Medtronic A tiempo completo

At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

This position is needed to lead the work with our partners in OI Quality Team to address the following key challenges:
(1) Define “One Best Way” IT testing processes to support team
- Define boundary between IT “Business Process” vs. “QMS”
- Define roles & responsibilities between Global IT, Global Mfg., GOSC Quality, Ops Innovation & CQS
- Standardize the use of processes by varying OI project teams, avoid opening compliance vulnerabilities
- Work with IT audit team to make sure MSCM is followed when applicable as well as help OI to leverage best practices

(2) Work with cross-functional resources
- Global IT Quality/Compliance
- Software Validation/QA support on site deployment teams

(3) Define and standardize the use of global tools
- PLM
- QMS entities
- Drive enhancements in the use of tools and making alignment with regulatory requirements

The role of the IT/OT Validation Lead for GOSC IT - Operations Innovation is to lead validation services required for the successful delivery of IT / OT projects. The role includes as requirement strong knowledge in Regulatory requirements for Application testing for ISO13485, CFR 21 Part 11 and SOX (if applicable). This role for a Principal Engineering Professional who is willing to work in Global environment with multiple functional areas like: IT, Ops &Innovation, QA and Mfg. SME’s.

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

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required r

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