Automation & Computer System Verification (CSV) Engineer
Linthwaite, Huddersfield
About the Company:
Thornton & Ross are one of the UK's fastest-growing, leading producers of household pharmaceutical products & own some of the country's most loved brands such as,, as well as the leading disinfectant. Many people in the UK will have a product from Thornton & Ross somewhere at home. We are also a trusted & reliable provider of prescription products, including emollients, bone health products & generics to the NHS with 100 years’ heritage behind us
We are part of the STADA group. STADA Arzneimittel AG is a German Stock Corporation with headquarters in Bad Vilbel, Germany. STADA focuses on a two-pillar strategy consisting of generics, including specialty pharmaceuticals & non-prescription consumer health products. Worldwide, STADA Arzneimittel AG sells its products in approximately 120 countries
Like all success stories, our company history started with a great idea. In 1895, a group of pharmacists had a common objective: The standardised production of medicinal products to ensure an effective and reasonable provision of healthcare. This was the beginning of STADA’s impressive development. We are now a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we continue to be a reliable and trustworthy partner. We help people regain and protect a dignified and able life. As STADA, we fundamentally care for people’s health as a trusted partner.
If you are ready for new challenges where you can make a difference to people’s health, you have come to the right place. We are looking for people with a great attitude and passion, who care about making a difference in the world.
About the Role:
The role exist to be responsible for the operation and maintenance of Automation Systems and for development, implementation and maintenance of validation compliance of computerized systems within STADA Technical Operations. This includes supporting the day-to-day activities of Production Plant and Engineering; providing engineering support for capital projects that will improve Plant capability, equipment reliability and efficient operation. It also includes execution of GMP CSV and associated Data Integrity activities at the Site.
Automation Engineer should have a solid background in Electrical Engineering and strong technical experience in automation, preferred in a Pharmaceutical/Life Sciences industry.
The role wil be a first point of contact as a Subject Matter Expert (SME) for assigned Automation Systems and related subjects in the supported business function. The role will:
1. provide guidance for the resolution of all Automation System related issues including any deviation investigation and/or trend analysis using the data available on the automation system.
2. manage external contractors in providing Engineering support for modifying and maintaining of the automation systems, building utilities and equipment to ensure optimal operation and reliability of the plant.
3. support continuous automation improvement projects to improve efficiencies and reliability of the system and processes.
4. identify new opportunities for automation within the manufacturing process.
5. be responsible for the corrective and preventive maintenance of the Production equipment. Troubleshooting automated processes or equipment when errors occur.
6. be responsible for the maintenance of the GMP relevant documentations (engineering SOP’s, design documentations etc).
7. provide trainings for associates on Automation Systems.
8. manage external contractors in providing engineering support for Capital and Expense Projects.
9. provide coaching of automation topics within his/her area of responsibility.
10. be responsible for procedures relevant to processes in life cycle of computerized systems and development of test protocols, determination of test parameters for testing computerized systems, support in conducting validation of computerized systems.
11. Review externally prepared documentation related to activities performed on computerized systems. Participate in ongoing maintenance of computerized systems and data management.
About You:
At STADA we talk about diversity as Uniqueness. Everyone is unique and we recognise our differences as a strength. Our values Entrepreneurship, Integrity, Agility and One STADA ensure our uniqueness thrives, enabling us to care for people’s health as a trusted partner. Empower your Uniqueness, bring your whole self to STADA. If you’re keen to add value and see results, thrive in a busy fast paced environment and have the can-do spirit that’s spearheading our success, bring those qualities, with the following:
12. Bachelor's Degree in Engineering ( Automation, Electronics, Mechatronics).
13. Strong experience in Automation Systems.
14. Experience in Pharmaceutical industry is preferred.
15. Knowledge in Programming / ISA95 level 1-2-3 control system components PLC-HMI – SCADA / ERP
16. Facilities, Utilities, Equipment Qualification experience or applicable experience in related area in the pharmaceutical industry.
17. Knowledge of computer system validation (CSV) requirements defined by pharmaceutical industry.
18. Knowledgeable in cGMP and regulatory requirements.
What’s in it for you?
Rewarding our employees is important to us, which is why we offer a range of fantastic benefits, such as:
19. Competitive base salary
20. 25 days annual leave (plus bank holidays) and the opportunity to buy an additional 5 days leave.
21. Generous Company Pension Scheme
22. Life Assurance
23. Annual bonus scheme.
24. Employee Assistance Programme