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Senior Validation Engineer

Date: Feb 1, 2019

Location: Rho, IT, 20017

Company: Teva Pharmaceuticals

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

Senior Validation Engineer

This position will provide expertise and leadership in validation strategy to the site projects.  This position will have engineering validation oversight and engineering validation signatory responsibility for approval of commissioning, qualification, validation, and final report documents.  This position will work in close cooperation with the manufacturing business units, Engineering, Regulatory, QC, and Quality Operations on a day-to-day basis.

This position will provide interpretation of regulatory requirements and provide input and guidance in relation to validation regulatory requirements. 

This position will provide scientific/technical expertise and consultation in cross functional project teams and to other members of the Engineering Validation department.

This position will assist in the review and preparation of regulatory submissions.

Essential Duties and Responsibilities

  • Manage, identify, hire, and develop team to support validation activities.  Manage continued growth, development, and retention of the team.
  • Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training as appropriate.
  • Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills.
  • Lead and interface with cross-functional team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle: user requirements, functional specifications, design specifications, commissioning and validation. Emphasis is on ensuring validation activities meet regulatory guidelines and industry standards.
  • Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results.
  • Identify gaps related to validation requirements and Global Validation procedures.  Drive and close compliance gaps as they are identified.
  • Review documentation for accuracy and compliance to established procedures with the ability to approve or reject as appropriate.
  • Ability to present a course of action to management and project team using both written and verbal communication tools.
  • Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors.  Present validation strategy and protocols in regulatory inspections.
  • Supervise, as needed, other validation personnel, contractors and outside vendors to meet project timelines, goals and milestones.
  • Monitor and report validation costs including capital and cross-functional expenses.
  • Lead in the drafting and implementation of Global Validation procedures including initiatives for harmonization and streamlining efforts.  Develop and implement new validation approaches as needed.
  • Provide planning and scheduling support for validation projects.  Responsible for defining validation scope of work, resources, and duration for projects to meet site-wide validation and budgetary goals.
  • Perform other duties as directed by supervisor.

Qualifications

  • Must have vast experience, proficiency and leadership in pharmaceutical/biotech validation elements, which includes the writing and executing of protocols and standard operating procedures.
  • Must be considered a proficient Subject Matter Expert (SME) in all validation elements.
  • Must have exceptional organizational skills and ability to analyze and plan and implement resolutions to technical problems, familiarity with auditing techniques, interpreting regulations and quality systems.
  • Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project.
  • Leadership and project management skills such as exceptional interpersonal/communication/influencing/negotiation skills/organization/prioritization.
  • Must be well versed in validation disciplines, Equipment, Facilities, Critical Systems, Utilities, Computer Systems, Process and Materials.
  • Strong knowledge of GMPs, FDA and EU guidelines/requirements, is required.
  • Must have sound industry knowledge, project proficiency, and autonomy expected. 
  • Must be able to lead and implement optimization of processes within the department or the site.
  • Must have advance experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities.

Education and/or experience

  • Minimum of a BS preferably in science or engineering (advanced degree preferred) or other job-related discipline.
  • Minimum 8+ years related experience
  • Experience in manufacturing processes and control systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning processes, process materials, process equipment, facilities and critical support systems are required.
  • Prior experience interacting with the FDA and other regulatory agencies a must.
  • Project management experience preferred.

Function

Engineering

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.