West Pharmaceutical Services

Principal Process Validation Engineer

West Pharmaceutical Services

full-time

Posted on:

Location Type: Hybrid

Location: Eschweiler • Germany

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Job Level

Lead

About the role

  • Contributing to the development and implementation of the validation engineering strategy
  • Ensuring qualification and validation of equipment, facilities, utilities, automated systems, processes and cleaning procedures are in accordance to GMP and relevant guidelines
  • Lead the validation effort for all Strategic Projects on site
  • Develop Validation Plans to support Site Validation Master Plan
  • Act as site subject matter expert on Cleaning Validation, Process Validation, Equipment Validation, Computer System Validation, Data Integrity and Facility Qualification
  • Preparation, review and approval of qualification and/or validation documentation (specifications, protocols, reports etc.)
  • Review and approval of third party generated protocols and reports
  • Fosters and encourages shared learning’s across the organisation
  • Chair, schedule and minute validation meetings
  • Perform periodic reviews of systems in order to maintain validation status
  • Develop and implement site validation strategy to meet customer and West needs
  • Represent West at customer meetings to ensure that the needs of the business are met
  • Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company
  • Ensure that all procedures are in place to facilitate the introduction of new processes and equipment
  • Lead and manage a high performing team to deliver the defined business goals and objectives.

Requirements

  • Bachelor's Degree in Computer Science, Engineering or related fields, or equivalent experience required
  • Minimum 8 years of validation engineer experience in a cGMP regulated industry
  • Experience working in a high-volume manufacturing environment, ideally in the Medical Device / Pharmaceutical sector
  • In-depth / working knowledge of ISO 13485; EU GMP, CFR Part 820
  • Excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems is desired
  • Must have excellent written and verbal communication skills as well as the ability to accurately document work performed
  • Demonstrated ability to lead, influence and train others
  • Must be able to work in a fast paced environment
  • Must be able to travel as required by the position
  • Must be able to organize and prioritize tasks; must be detail orientated and self-motivated
  • An ability to collaborate across functional teams and work effectively in a matrixed team environment
  • Must be able to work independently on own projects while working concurrently with all departments.
Benefits
  • We empower the physical, mental, emotional and financial health of our team members and their families.
  • Supported by benefit programs, we believe in giving back to help those in need in the communities where we live and work.
  • Committed to creating a healthier environment and planet through our sustainability efforts.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
validation engineeringCleaning ValidationProcess ValidationEquipment ValidationComputer System ValidationData IntegrityFacility Qualificationqualification documentationvalidation documentationanalytical methods
Soft Skills
written communicationverbal communicationleadershipinfluencetrainingorganizationprioritizationdetail orientationself-motivationcollaboration
Certifications
Bachelor's DegreeISO 13485cGMP