Senior Validation Engineer

Reporting into: Head of NPI (Line Manager)

Company

Do you want to make a difference while advancing your career? Come join Osler.

We are a UK diagnostics Company whose purpose is to enable anyone, anywhere, to access, understand, and act on their health, to live healthier, happier, and longer lives.

We are realising this through the development of the Osler Origin – a 'portable lab' capable of performing a wide range of testing, with lab-quality performance, in a portable, rapid, low-cost, and easy-to-use manner. The Osler Origin will offer a wide portfolio of diagnostic tests and serve all major healthcare settings, globally.

The Osler Origin is powered by a portfolio of novel techniques and approaches for sample addition, microfluidic sample preparation, and electrochemical biosensing, and Osler was formed out of the University of Oxford in 2017, following decades of research.

Having recently completed an $85m Series C fundraise, we are now entering a growth phase, where we are scaling our team as we take the Osler Origin product through regulatory activities, and towards market launch.

Join us and help build a better future.

About the role

This role will be responsible for documenting the 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.

Initially this role will work closely with cross functional development teams to establish the scope of validation activities needed to successfully transfer a new product platform (analyser, chemistry, and cartridge) from development to a production state. The role will expand to the full life cycle of the platform encompassing the on-market scale up to high volume and subsequent ongoing pipeline development programs.

Applying your expertise and experience in validation, you will be expected to work with Quality to develop lean and compliant Standard Operating Procedures (SOP's) that govern the scoping and definition of validation activities and deliverables. You will be the site Validation Master Plan (VMP) owner and drive the subsequent planning of tasks, sequencing, timelines, and resources, and the co-ordination of daily and weekly activities to ensure plans and outcomes are achieved.

The role is envisaged to be both a key point of contact within the distinct work packages across the platform as well as a subject matter expert offering support and guidance when called upon by team members planning and executing validation activities.

Operating through a matrix structure model, and at the coalface of project activities, you will be expected to lead a blend of internal technical resources to deliver validation deliverables and facilitate external suppliers and/or service providers to establish a compliant validated state.

Within the matrix structure they should lead by example - championing and role-modelling the core values of Osler Diagnostics in all activities and interactions undertaken.

Main responsibilities:

• In all areas within own remit, foster a workplace culture that prioritises the health, safety, and well-being of its employees, demonstrating a commitment to communicating, improving, and adhering to safety policies. Challenge and/or escalate non-conformance or contrary behaviours where known
• 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. Ensure this is underpinned by risk management
• Assume 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 SOP's and templates that govern and control validation. Ensure 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 co-ordinated to ensure robust outcomes. Assign activities to work package owners, agreeing timings
• Assemble and circulate reports to document status of validation activities across site
• Act as a coach and mentor to colleagues improving knowledge, competence, and capability, of individuals and teams
• Act as key Point of Contact for other functions across the business, supporting engineering change control, quality investigations, productivity initiatives, risk mitigations, and 3rd party partnering. Proactively develop, maintain, and leverage collaborative, cross-functional relationships (Product Development, Manufacturing Engineering, Supply Chain, Production, Facilities, Quality) and external networks/relationships in support of own, and wider, business deliverables
• Contribute to the selection, and facilitate the on-boarding, 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
• Contributes at key programme 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. Provide confidence in the installed system, process, facility, or procedure

Skills, Experience, & Attributes

• 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 organisational, planning, and follow-up skills and ability to hold others accountable
• Multi-tasks, prioritises, and meets deadlines in 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 relevant engineering discipline
• Project management accreditation
• Formally trained in Lean/Six Sigma philosophies and tool kits

We offer a competitive benefits package, with a focus on health and well-being - further supporting the belief in our mission to enable anyone, anywhere, to access, understand and act on their health.

• 25 days holiday + bank holidays and a Christmas closure
• Annual Learning & Development budget 4% of your salary
• 12 days of Learning leave
• £500 Well-being allowance
• Private Medical Insurance - (includes subsidised gym memberships)
• 24/7 access to a GP
• Life Assurance - x4 annual salary
• Income Protection - 75% of your basic annual salary
• Private Travel Insurance
• Annual eye tests
• Cycle to work scheme
• Travel to work loan scheme
• Relocation assistance
• Volunteering leave
• Give as you earn - pre-tax salary donations to any UK charitable organisation
• Quarterly team building events and social events
• Enhanced maternity / paternity leave

There is no perfect candidate, and no single person can do it all, but if this sounds like you, or what you could be and you're looking for somewhere to thrive; we want to hear from you.

We look forward to receiving your application. If you have any questions, please contact