Validation Engineer

Posted 13 Sep 2018

Madison, Wisconsin - United States

Req Id 181420

Details

A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.


Your Role: Validation Engineers are recognized as a strong quality presence and technical resource. This position is responsible for developing, reviewing, and managing the execution of validation activities for the facility utilities, equipment and processes used in the manufacture and testing of cGMP products.

In the role of Validation Engineer, you will also be interacting cross-functionally with Manufacturing, Project Management, Process & Analytical Development, Quality Control, Quality Assurance, Packaging, Materials Management, Engineering, and Maintenance.

Responsibilities:

  • Establish a Master Validation Plan, review and implement all necessary standard operating procedures for plant processes, equipment installation and operational qualification (IQ/OQ), performance qualification (PQ), requalification and revalidation of critical systems and utilities.
  • Review, plan, schedule and implement new and existing validation projects including facility systems, manufacturing equipment and processes, analytical instrumentation, and cleaning processes.
  • Recommend validation and qualification approaches, strategies, priorities and required resources during project planning and development phases.
  • Develop and prepare protocols for process and cleaning validation, equipment commissioning and qualification (including but not limited to FAT/SAT/IOQ and PQ).
  • Coordinate and oversee scheduled validation and qualification activities with facility and production engineers and operators, process and analytical development personnel, quality control staff, customers and external contractors and service providers.
  • Review and analyze analytical and physical data generated from executed validation/qualification activities. Write validation/qualification final reports that present, summarize and offer conclusions on the validity of the processes based on objective evidence, obtain necessary approvals.
  • Work with Development, Manufacturing and Quality personnel to generate risk management deliverables for new projects (Preliminary Hazard Analysis Assessments, Criticality Assessments, System Impact Assessments, Risk Management Reports, Failure Mode and Effects Analysis).
  • Be a leader of the Management of Change system to determine the impact of proposed changes to the validation/qualification status of equipment, processes, software, and/or facilities.
  • Report status and progress of validation/qualification activities or projects to the Leadership team.
  • Specific Responsibilities to include:
    • Facility Validation and Equipment Qualification:
      • Develop/Establish an overall plan for qualifying new equipment or new/upgraded facility and establish proper controls for the introduction of equipment/facility and/or changes under proper quality standards (e.g. FDA, EU, ISO, ICH, ISPE, etc.)
      • Identify and establish revalidation and requalification requirements
      • Write and execute validation and qualification protocols including identification, investigation and resolution of non-conformances and deviations
      • Author validation/qualification final reports
    • Process Validation:
      • Develop risk based process validation protocols in consultation with Process Development and Manufacturing
      • Author process validation summary reports
    • Cleaning Validation:
      • Develop cleaning validation protocols for equipment and facilities
      • Develop clean/dirty hold times
      • Basic Qualifications

        • 1-3 years experience working in a regulated environment (will consider recent grad)
        • Working knowledge of Standard Operating Procedures and Protocols/Reports
        • Understanding of validation/qualification strategies
        • Knowledge of applicable quality regulations and standards
        • Quality or quality support experience in a regulated environment (GLP, cGMP, ISO)

        Preferred

        • 1-3 years quality assurance or quality control experience in cGMP pharmaceutical or drug development organization
        • Working knowledge of facility equipment commissioning and qualification
        • Working knowledge of process and cleaning validation
        • Working knowledge of Computer System Validation
        • Quality assurance or quality control experience in a cGMP pharmaceutical setting

Who you are:

  • Education: B.S. in an Engineering discipline, or Life Science degree
  • Experience:
    • Required: 4-7 years quality or quality support experience in a cGMP pharmaceutical setting
    • Desired: 4-7 years facility, equipment, and/or cleaning validation experience in a cGMP manufacturing setting
    • Sound working knowledge of processing equipment used to manufacture APIs
    • Knowledge of clean room standards
  • Professional Skills, Qualifications and Experience:
    • Strong ability to manage multiple priorities, self-starter attitude, good oral and writing skills and the ability to work independently and as a team in an efficient manner.
    • Ability to utilize GDP during document creation and review.
    • Working knowledge of current regulatory guidelines and standards.
    • Ability to apply and incorporate pharmaceutical standards, rules and guidances. (e.g. FDA, EU, ISO, ICH, ISPE, etc.)
  • Comfortable in a fast-paced environment with the ability to adjust to changing priorities.
  • Flexible and accountable.
  • Detailed oriented work standards.
  • Travel Requirements: minimal travel required for the execution of FAT’s.
  • Pre-Employment testing requirements:
    • Physical Requirements (PPE, lifting): This position may require use of personal protective equipment including respirators and full body suits, lifting of no more than 35lbs.
    • Work schedule: Day shift

What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!

EMDRSR

Curious? Apply and find more information at come2emd.com

The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

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