Validation Engineer

PlaceMe Recruitment - Tullamore, County Offaly (5 months ago)

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Overview: To be a member of the engineering team who are the technical authority for all the products manufactured in the plant. To lead the validation activities applicable to the assigned products owned by the Tullamore facility. To collaborate with all relevant departments to deliver the essential duties and responsibilities listed below.

    • Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.·
      • Minimum of Degree in relevant engineering discipline.
      • Have a minimum of 5 years’ experience in medical device or similar industry with an established track record.
      • Good Project Management skills required, with ability to manage product transfers.
      • Proven ability to provide technical leadership to engineers and project teams.
      • Ability to share technical expertise with colleagues i.e. able to express information clearly and concisely both verbally and in written format.
      • Good problem solving abilities – able to identify facts, consider a number of alternative approaches and evaluate the most appropriate course of action.
      • Team and results orientated - committed and energetic approach to work with positive attitude.
      • Proven reliability – efficient, results-orientated and manages own time well.
      • Ability to deal effectively with all employees and external business contacts while conveying a positive, service-oriented attitude.
      • Six Sigma/lean experience in the manufacturing and design of new products is desired.
      • Good interpersonal and communication skills.
      • Ability to work to tight project timelines and within approved budgets.
      • Some electronics knowledge/experience would be an advantage.

      • To manage and co-ordinate technical support for the introduction of new products, in line with site plans.
      • To effectively manage the introduction of technology on lines, modifications and process improvements.
      • Develop manufacturing technical capabilities and skills so as to ensure ongoing process requirements can be effectively achieved
      • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
      • Develop strong links with our sister plants so as to ensure effective ongoing transfer and sharing of products, processes and systems.
      • In response to in-house quality levels and product complaints, develop process improvement projects so as to achieve the highest quality standards.
      • Generate Process and Test method validation protocols and reports. Ensure that process validations and work methods are adequate to maintain the highest quality standards.
      • Through effective information flow and interaction, develop harmonious working relationships within engineering and other functions, and ensure employees within operations engineering have the necessary information and resources to effectively perform their jobs.
      • Provide technical support in field related activities such as clinical programmes and complaint investigations.
      • Ensure safety standards and awareness within the operations/sustaining engineering group are in compliance with legislation and issues effectively dealt with.
      • To prepare technical documentation such as standard operating procedures, safety programmes, validation protocols, technical reports, engineering calculations, change controls and other documentation as required.
      • To provide technical leadership and structured approach to problem solving for operations personnel involved in process engineering and development activities.
      • To present, where appropriate, technical data to internal / external audit and inspection groups as required.
      • Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
      • Will comply with all relevant training required and adhere to relevant associated documentation.
      • Follow strict adherence to the requirements of cGMP.
      • Actively contribute to the enhancement of compliance initiatives for areas of responsibility.