As Senior Validation Engineer you will lead key validation activities in a new sterile manufacturing facility and help develop the structure and compliance of the validation department. You will be responsible for validating/qualifying systems and equipment and will develop QRM principles for validation activities that support the company QRM goals. You will also be responsible for the validation of equipment, processes, and facility utilities for cGMP production and will lead the preparation and execution of protocols to demonstrate that manufacturing equipment and processes are carried out with consistent quality and results. In addition, you will be responsible for managing and/ or performing revalidation, engineering studies to evaluate new products or components, change control assessments, investigations and coordination of computer and method validations of applicable products.
What you will be doing?
- Responsible for generating and driving the high-level validation governance documents
- Line management, and development of, validation engineers assigned to you.
- Organising people/resources to complete validation activities as necessary within project matrix structure.
- Preparing validation and performance qualification protocols
- Developing, preparing, and installing new equipment and revising test validation procedures/protocols
- Coordinate projects directly with vendors and service providers
- Coordinate the implementation or scheduling of validation testing
- Compiling and analysing validation data, preparing reports, and making recommendations
- Conducting validation deviations and participating in cross functional deviation investigations.
- Participating and presenting data in Regulatory Agency, Customer, Corporate and Internal audits.
- Participating in developments to validation and company programs as needed to remain current with cGMPs and industry standards.
What we are looking for:
- Minimum 3 years of validation experience or related quality experience in a cGMP Device or Drug environment and minimum 5 years’ experience in a pharmaceutical or Medical Device manufacturing environment.
- Bachelor’s Degree in science, Biology, Chemistry or Engineering preferred.
- Knowledge and Experience of GAMP and Computer System Validation CFR21 Part 11/Annex 11.
- Demonstrated experience of regulated industry validation lifecycle activities
- Strong technical knowledge and experience with validation/qualification of pharmaceutical processes, equipment, utilities, facilities and/or computer systems as related to sterile products and medical devices.
- Experience with leading validation deviation and change control procedures
- Six Sigma or Lean certification or working knowledge of the principles
- Excellent attention to detail and working knowledge of ISO, EU and FDA Regulations/Guidance, and Good Manufacturing Practices is essential.
- Highly motivated individual who is happy working by themselves or in cross functional groups in a relatively flat structure.
- Open, honest, inclusive, personable.
- A team player with good interpersonal and communication skills.
- Ability to influence stakeholders to achieve the goals of the company.
- Able to both ‘see the big picture’ and develop robust detail design.
- Willingness to travel as required to fulfil role.
How do I apply?
If you are interested, please send a CV and covering letter to firstname.lastname@example.org with the subject line “Senior Validation Engineer”.