15 Dec, 2020

Process Validation Engineer

  • Thermo Fisher Scientific
  • Swindon, UK
Chartered Engineer,   Process Engineer   Biochemicals / Pharmaceuticals

Job Description

When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

 

At our site in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs, with successful recent partnerships including Flexion and Pacira.

 

How will you make an impact?

We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivalled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.

 

The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.


What will you do?

  • Generation, execution and review of process validation (stage 2) and Continued Process Verification (CPV) (stage 3) documentation for processes either onsite or introduced to site

  • Leading the process validation and CPV activities on site ensuring all site, industry, and regulatory requirements are attained and maintained

  • Maintain inspection readiness for process validation across the site

  • In-depth Knowledge of Annex 15 to vol 4 EU GMP “Qualification and Validation” and FDA Guidance for industry process validation

  • Deliver coordination and management of the process validation and input validation requirements into the Technology Transfer process of new commercial products that are introduces to the site

  • To ensure that all documentation is prepared, authorised and completed in a timely manner.

  • To ensure that all tasks are carried out in an effective and efficient manner.

  • To ensure that appropriate training records are maintained.

  • To communicate effectively with others on site and the client associated with the project.

  • To supervise work of those undertaking validation activities

  • To maintain an understanding of current international regulatory, ISO, corporate and client requirements relevant to the section.

  • To ensure compliance with the sections and site procedures.

  • To liaise with the various departments involved in the qualification and validation work to ensure the efficient performance of the related tasks.

  • To ensure that adequate training has been received and documented

  • To present process validation and CPV activities to an auditor

  • Comply with GMP requirements and company rules, policies and procedures.

How will you get here?

  • You will be an experienced Quality Operations/Validation professional with and in-depth knowledge or GMP along with previous experience of using the “V” model approach to validation. You’ll have a project management background in either Engineering, Validation or Quality and will have worked with clients as well as internal stakeholders.

  • In-depth knowledge and understanding of cGMP.

  • Dynamic, self-motivated, pro-active approach to taking on challenging assignments.

  • Demonstrable experience in Quality Operations/Validation of process validation

  • Previous experience of applying “V” model approach to validation activities

  • Creativity, judgement and analytical thinking.

  • Ability to work with critical timelines.

  • An excellent planner, who can envision short-term milestones which the company must achieve to succeed in the long-term.

  • Outstanding communication skills, both written and oral, and the self-confidence to use these skills to convince others to buy-into proposals and plans.

  • Strong project ownership ethic with a “can do” attitude.

  • Ability to motivate, communicate and lead cross functional teams to deliver project timelines

  • The drive and maturity to lead combined with the ability to support and interface effectively with projects and motivate cross functional teams

 

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 75,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Bio systems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.


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