Job Summary
In this role, you will be responsible for contributing to the development and implementation of the validation engineering strategy whilst ensuring the qualification and validation of equipment, facilities, utilities, automated systems, processes and process cleaning procedures are carried out in accordance to GMP and relevant guidelines.
Essential Duties and Responsibilities
1. Lead the validation effort for all Strategic Projects on site.
2. Lead the preparation, review, and approval of the Site Validation Master Plan.
3. Develop Validation Plans to support Site Validation Master Plan.
4. Site subject matter expert on Cleaning Validation, Process Validation, Equipment Validation, Computer System Validation, Data Integrity and Facility Qualification.
5. Preparation, review and or approval of qualification and/or validation documentation (specifications, protocols, reports etc.) in relation to instrument, equipment, facilities, utilities, automated systems, manufacturing processes and cleaning processes including FAT, SAT, IQ, OQ, PQ phases in conjunction with program Quality representation.
6. Review and approval of third party generated protocols and reports in conjunction with program Quality representation.
7. Fosters and encourages shared learning’s across the organisation e.g. system and technology best practices.
8. Chair, schedule and minute validation meetings and participate in meetings when required.
9. Preparation, review, and approval of standard operating procedures and policies.
10. Perform periodic reviews of systems in order to maintain validation status.
11. Support the set-up and maintenance of electronic validation documentation while ensuring the archiving and
12. filing of hard copy validation documentation across all projects.
13. Develop and implement site validation strategy to meet customer and West needs.
14. Work with all departments across the business to ensure that new processes meet their requirements.
15. Represent West at customer meetings to ensure that the needs of the business are met.
16. Assist with the training and development of personnel at all levels of West on new processes or systems introduced to the company.
17. Ensure that the procedures and systems are in place to facilitate the introduction of new processes and equipment.
18. Lead and manage a high performing team to deliver the defined business goals and objectives.
19. Other duties as assigned.
Additional Responsibilities
20. He/She is authorized to make a decision to stop work in the plant in accordance with official procedure of West Pharmaceutical services, in cases of huge material damages and/or employees being in jeopardy, especially in absence of Production manager.
21. He/She is authorized to approve entrance of third parties into the plant, in accordance with official procedure of West Pharmaceutical services.
Education
22. Bachelor's Degree Must have a third level qualification, at a minimum to degree level, in Computer Science, Engineering or related fields or equivalent experience required
Work Experience
23. Minimum 8 years of validation engineer experience in a cGMP regulated industry, and experience of working in a high-volume manufacturing environment ideally in the Medical Device / Pharmaceutical sector. required
Preferred Knowledge, Skills and Abilities
24. Must have in-depth / working knowledge of: ISO 13485; EU GMP, CFR Part 820.
25. An excellent understanding of plastic process manufacturing, computer validation, analytical methods and testing and documentation systems is desired.
26. Must have dealt with customers in a previous employment.
27. Must have excellent written and verbal communication skills as well as the ability to accurately document work performed.
28. Demonstrated ability to lead, influence and train others.
29. Must be able to work in a fast paced environment.
30. Must be able to travel as required by the position.
31. Must be able to organize and prioritize tasks; must be detail orientated and self-motivated.
32. An ability to collaborate across functional teams and work effectively in a matrixed team environment.
33. Must be able to work independently on own projects while working concurrently with all departments.
34. Support and contribute in Lean Sigma programs and activities towards delivery of the set target
35. Able to comply with the company’s safety and quality policies at all times
Travel Requirements
5%: Up to 13 business days per year
Physical Requirements
Sedentary-Exerting up to 10lbs/4kgs of force occasionally, and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body. Sedentary work involves sitting most of the time.
Additional Requirements
36. Able to routinely use standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines. Position operates in a professional office environment. May stand or sit for extended periods of time
37. Must be able to communicate effectively with written and oral skills, make quick decisions, interpret data, read and write, speak in front of groups, express and exchange ideas, understand direction and adhere to procedures
38. Read and interpret data, information and documents
39. Must maintain the ability to work well with others in a variety of situations
40. Must be able to multi-task, work under time constraints, problem solve, and prioritize
41. Ability to make independent and sound judgments
42. Observe and interpret situations, analyze and solve problems
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