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Title:  Senior Eng, Process Validation

Requisition ID:  53627
Date:  Sep 1, 2022
Location: 

St Petersburg, Florida, US

Department:  Engineering
Description: 

 

 

Working at West means having an opportunity to work by the side of our patients and customers, our global team members and the communities in which we operate – which all help contribute to a Healthier World.

 

At West, we are by the side of patients. The work we do impacts patients’ lives each and every day – our products are a critical part of healthcare delivery and we are proud of the role we play to improve patient health. We work by the side of our team members. We come together as one global team to deliver for our customers and help them address their challenges. We are a diverse, close-knit community of professionals, where everyone has a voice and opportunity to learn and grow through mutual trust and respect. With a 95 year plus history, we have a track record for success, which includes reported sales of $2.14B in 2020. We serve by the side of our community. Giving back is in our DNA—our team members across more than 50 sites globally are involved with hundreds of charities that have special meaning to them through our West Without Borders team member-led giving program.

 

Job Summary:

The Senior Engineer Process Validation is a member of the West Global Engineering Team. This role is key in the implementation of new technologies, development, and introduction of process improvements, standards, life cycle management and validation in all process areas, helping to advance and transform West’s growing business, supporting capital investments, and contributing to addressing complex assignments. With a global mandate and scope, this person will have the opportunity to ensure harmonization and standardization in the preparation and execution of the validation life cycle deliverables in cooperation with the engineering and quality assurance teams and the plants.

 

Essential Duties and Responsibilities:

  • The SME area in focus is Validation
  • Manage and roll out validation best practice concepts globally
  • Support the introduction, start-up, and validation of new equipment in the local sites to guarantee a short start-up time
  • Initiate, lead, and coordinate the validation workstream in global and local projects to ensure that the validation requirements are followed and maintained
  • Prepare, review and approval of validation lifecycle documentation as part of global and local projects
  • Initiate and maintain appropriate communication with facilities and departments to support good relations and maximize achievements through a cooperative environment
  • Ensure the implementation of the best practice validation concept as part of Site Validation Plan approval
  • Support validation activities for product, process or technology transfer projects as assigned
  • Evaluate and approve Change requests related to validation as assigned
  • As part of the global SME network, demonstrate advanced knowledge of specific processes to support the Global OPS organization in solving validation related issue requiring involvement
  • Provide guidance including reporting, investigations, and review as part of the resolution of any issues related to the execution and approval of validation protocols
  • Ensure that all projects and activities comply with local, regional and best practice requirements and meet other applicable authority requirements
  • Lead workstreams to implement/roll-out new validation tools in cooperation with the Engineering- and QA team and the plants
  • Manage and maintain a system to provide validation lifecycle documentation to the global and local Engineering teams
  • Perform validation related training for validation teams to guarantee that all members have enough knowledge of validation requirements to allow them to carry out their duties
  • Lead process improvement projects in the local site as part of the global PE objectives
  • Participate in other duties as assigned

Basic Qualifications: 

  • Bachelor’s degree in engineering or another scientific area
  • Minimum 5 years’ experience in a similar position within the manufacturing industry
  • Good knowledge of LEAN and 6 sigma manufacturing principles: minimum 6 sigma green belt
  • Fluent in English
  • Proficient in Document Control Systems and Microsoft based programs

Preferred Knowledge, Skills and Abilities:

  • Master’s degree in engineering or another scientific area
  • Sound know-how and experience in Project management
  • Knowledge in Risk Management tools
  • Knowledge of statistical tools and Minitab
  • Knowledge of cGMP regulations like 21 CFR 210, 211, 820 and Part 11; EU GMP Annex 11 and 15, etc.
  • Must have comprehensive understanding of process requirements and applicable systems
  • Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
  • Support and contribute to Lean Sigma programs and activities towards delivery of the set target
  • Able to comply with the company’s safety policy at all times
  • Able to comply with the company’s quality policy at all times

 

Travel Requirements:

  • Must be able to travel up to 10 % of the time

 

Physical & Mental Requirements:

  • Very good organizational and project management skills
  • Self-motivated, results and solution-oriented personality
  • Ability to successfully collaborate with teams across different countries and organizational levels
  • Must be able to multi-task, work under time constraints, problem solve, and prioritize.
  • Effectively use written and oral communication skills
  • Read and interpret data, information, and documents
  • Analyze and solve problems within scope

 

 

 

 

 

 

West is an equal opportunity employer and we value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sex, gender identity, sexual orientation, age, marital status, veteran status, or disability status.  If you have a special need that requires accommodation in order to apply to West, please send an email to Apply.Accommodation@westpharma.com.  Where permitted by law, an offer of employment with West Pharmaceutical Services, or any of its subsidiary or affiliate companies, is contingent upon the satisfactory completion of background screening and/or a pre-employment drug screening.

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