Location: Santa Clara, CA Duration: 12+ Months JOB SUMMARY: Responsible for developing operations validation strategy for the project team by gathering and determining appropriate inputs and key stakeholder alignment. This role supports strategic projects and programs (e.g. IVD product launches, RUO to IVD, IVD readiness, etc) by ensuring production sites have all necessary prerequisites needed to prepare, approve, and execute detailed validation protocols that meet the relevant testing standards per global and local requirements. Key deliverables include defining and documenting a comprehensive operations validation strategy, documenting a validation plan from the aligned strategy, and driving deliverables from various sites and stakeholders across the organization.
DISTINGUISHING CHARACTERISTICS:
Must be adept at managing stakeholder relationships and ensuring clear and timely communication for partners in the project, including identifying and resolving risks and facilitating agreement.
Critical to the role is to seek out relevant discussion points to fully define and constrain a comprehensive validation strategy for the project.
Confident, clear, and concise communication is necessary for success in this role: in writing, verbally, and using electronic collaboration tools.
Must have thorough knowledge of IVDD requirements, and familiarity with IVDR.
Accountable to the project team with transparent weekly project team updates on current status of validation activities.
Must be a self-motivated individual with the ability to work independently and in partnership with others.
ESSENTIAL RESPONSIBILITIES:
Validation Support A key focus for the role is to orchestrate validation related activities supporting RUO to IVD, IVD readiness, and/or IVD strategic projects and programs as well as to successfully meet all validation related milestones for the projects. o Develop the strategy and framework for ROU to IVD, IVD readiness, IVD initiatives in RSS. o Interface between project lead, senior management, and project core team members by communicating technical input, feedback, concerns, risks and key decisions and by cascading decisions, guidance, and input. o Lead the validation workstream. Collaborate and partner with stakeholders from different sites to develop and implement project validation master plans and harmonize network and local procedures as needed. o Provide technical expertise needed to successfully complete validation deliverables and foster stakeholder alignment (e.g. Quality, MSAT, Development, Manufacturing, QC, Commercial, etc.) o Identify efficiency and optimization opportunities. The role will be a key interface or bridge between development and operations, and will work with RUO, ROU to IVD, and/or IVD products. o Provide awareness of E2E Process Validation (PV) included but not limited to PV implementation, requirements, risks assessments, and mitigation plans. Manage and work with respective sites to develop robust validation procedures and prepare associated documentation (Master Validation Plan (MVP), Validation Plans, protocols, SOPs, Work Instructions, Manufacturing Instructions and Forms) to meet ROU to IVD / IVD readiness requirements. This can potentially include scale-up production opportunities or improvement of enzymes, bulk solutions, and aliquoted product (filling processes). Designs validation sampling/test plans. Resolves technical issues encountered. Tracking and expediting the review and sign-off of validation documentation. As applicable, prepare Validation documentation and execute validation studies. Specifically, this role will prepare the Validation Plan and Summary Report. Drive completion of validation activities and prerequisites according to master plan.
Influencing, Negotiating, and Problem solving Foster the collaboration with senior leaders, sponsors, project lead, etc. Positively manage partners and key stakeholders in order to clearly, concisely, and progressively provide awareness of Validation.
Manage QA Systems Raise CAPAs, NCRs and Change Requests where required and assist with investigations. Manage validation workload arising from unscheduled events. Assist during internal and 3rd party audits with regards to validation requirements by interacting with auditors during inspection or audits.
Relationships Establish, nurture and maintain good working relationships with internal and external stakeholders through regular communication.
Communication Communicate the status of validation to the business on a regular basis. Communicate as frequently as possible to ensure that all stakeholders are informed at all times MINIMUM QUALIFICATIONS:
Formal Training/Education:
Science or Engineering diploma/ degree; or certificate in a scientific discipline.
Experience
Minimum seven years demonstrable experience related to leading local and/or global strategic projects and validation plans development.
Minimum of five years’ previous process, test method, and cleaning validation, as well as understanding of process characterization
Validation and qualification experience in equipment, utilities, facility, shipping, and computer system validation will be advantageous
Must be from the diagnostic/pharmaceutical/biotech industry.
Knowledge, Skills, and Abilities:
Ability to influence, negotiate, and communicate effectively at all levels of the organization in verbal and written form, including technical/business writing.
Strong quality mindset.
Able to work independently and multi-task.
Working knowledge of ISO Quality Management systems would be preferred.
Personal Competencies: Work independently or in collaboration with others, strong work ethic, communication skills, Planning and organising, problem analysis and solving, effective time management, accountability.
Interpersonal Competencies: Good communicator, team player, change management, motivating, professionalism.
Managerial competences: Sense of urgency, assertiveness.
Thanks & Regards, Kalyan Raj | Sr Recruiter Email: Phone:
