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Senior Validation Engineer
2 months ago
This position will be responsible for developing and implementing a site validation strategy, providing oversight of its execution, including the qualification and re-qualification of facilities, utilities, equipment, computerized systems, cleaning, test methods, and process validation.
The successful candidate will apply their expertise and experience in validation to work with Quality to develop lean and compliant Standard Operating Procedures (SOPs) that govern the scoping and definition of validation activities and deliverables.
They will be the site Validation Master Plan (VMP) owner and drive the subsequent planning of tasks, sequencing, timelines, and resources, and the coordination of daily and weekly activities to ensure plans and outcomes are achieved.
The role will involve leading a blend of internal technical resources to deliver validation deliverables and facilitating external suppliers and/or service providers to establish a compliant validated state.
Key Responsibilities
- Foster a workplace culture that prioritizes the health, safety, and well-being of employees, demonstrating a commitment to communicating, improving, and adhering to safety policies.
- Develop, with appropriate team input, the VMP that will describe the principles involved in the facility qualification, defining the areas and systems to be validated, and provide a written program for achieving and maintaining a qualified facility.
- Assume the role of Subject Matter Expert (SME) for all Process Validation activities, proactively applying own expertise to identify potential risks to the efficacy of defined outcomes and clarifying areas of technical complexity.
- Provide SME input into SOPs and templates that govern and control validation, ensuring compliance is maintained with all current and applicable Regulations.
- Decompose and establish documentation structure and sub-plans for project validation activities to meet VMP requirements.
- Ensure sequencing of qualification and validation activities are considered and coordinated to ensure robust outcomes, assigning activities to work package owners, agreeing timings.
- Assemble and circulate reports to document the status of validation activities across the site.
- Act as a coach and mentor to colleagues, improving knowledge, competence, and capability, of individuals and teams.
- Act as the key Point of Contact for other functions across the business, supporting engineering change control, quality investigations, productivity initiatives, risk mitigations, and 3rd party partnering.
- Contribute to the selection and facilitate the onboarding of new suppliers, supporting the evaluation of vendor capabilities.
- Produce relevant and appropriate reports providing data, commentary, and narrative to key stakeholders, senior management, and third parties as required.
- Contribute at key program and design and development reviews, as required, representing transfer and the validation discipline.
- Actively promote the creation of a work environment, supported by leadership, which fosters openness, trust, communication, teamwork, empowerment, innovation, and satisfaction.
- Defend policies, program, and validation documentation during audits, regulatory inspections, providing confidence in the installed system, process, facility, or procedure.
Requirements
- Time-served Senior Validation Engineer/Manager with extensive experience and expertise in the transfer and validation of products in highly regulated industries.
- Strong analytical skillset with the ability to identify risks to product, process performance, and compliance.
- Proven ability to identify, assess, and solve complex problems using established tools and methodologies.
- Excellent communicator who leverages well-developed interpersonal, influencing, and networking skills to build effective relationships, influence decision-making, and drive outcomes.
- Strong verbal and written communications capabilities.
- Strong organizational, planning, and follow-up skills and ability to hold others accountable.
- Multi-tasks, prioritizes, and meets deadlines in a timely manner.
- Proven team leadership skills, including the ability to set goals, promote personal accountability, and strong team engagement, through positive and constructive feedback.
- Driven and resilient, with the ability to work effectively within a fast-paced changing environment while continually growing and developing own self.
- Experience of working in MedTech or ISO13485 or highly regulated sectors.
Preferred
- Degree (or equivalent) in a relevant engineering discipline.
- Project management accreditation.
- Formally trained in Lean/Six Sigma philosophies and tool kits.
