Computer Systems Validation Engineer

WOOD GROUP; England; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A reputed engineering company in the United Kingdom is seeking a Computer Systems Validation Engineer for a fixed term contract of 12 months, based in Worthing. The role involves developing user requirements, executing validation documentation, and ensuring compliance with regulatory guidelines. Candidates should have a Bachelor of Science or Arts and experience in pharmaceutical manufacturing. The company promotes flexible working arrangements and values diversity and inclusion in hiring.

Benefits

Flexible working arrangements

Commitment to Diversity and Inclusion

Meaningful and interesting projects

Qualifications

• Experience with Quality systems like Change control, CAPA, and deviations.

Responsibilities

• Work with end business users on development of user requirements and specifications.
• Approve technical design documentation supplied by vendors.
• Identify and mitigate system risks through technical risk assessments.
• Plan, develop and execute validation documentation for multiple projects.
• Utilise electronic validation systems (KNEAT) to complete validation activities.

Skills

Pharmaceutical Manufacturing and Computerised Systems and Validation

Experience with ISPE GAMP Computer System Development Life cycle methodology

Knowledge of Client Server environment, UNIX, NT, Windows

Education

Bachelor of Science or Arts or equivalent experience

Job description

Job Description

Remarkable people, trusted by clients to design and advance the world.

Wood Process & Energy is looking for a Computer Systems Validation (CSV) Engineer on a fixed term contract basis for 12 months. This role is based at our clients offices in Worthing.

Our Clients and Projects

Designing the future. Transforming the world.

P&E offers a wide range of opportunities which will allow you to develop your skills across a portfolio of onshore projects in different sectors. Our current portfolio includes green hydrogen and fuel switching, as well as supporting local clients with energy transition. Additionally, we work on UK refineries, petrochemical facilities, fine chemicals and pharmaceutical facilities. We have a number of clients who we are working with to design their pilot plants to test exciting new technologies, with a view to partnering with them as they move to design and build full scale commercial facilities.

What we can offer

• Meaningful and interesting projects we support green hydrogen and fuel switching, as well as supporting local clients with energy transition
• Flexible working arrangements that balance client, team and individual needs offering hybrid working arrangements
• Commitment to Diversity and Inclusion we are an organisation actively committed to diversity and inclusion across our business with employee networks committed to giving all employees a voice
• Global connections join experts around the world who are at the leading edge of our industry, shaping the standards of our profession

Responsibilities

• Work with end business users on development of user requirements and specifications.
• Approve technical design documentation supplied by vendors such as hardware/ Software / Functional Design Specifications.
• Identify and mitigate system risks through use of Client's Technical Risk Assessment process.
• Plan, develop and execute validation documentation including validation master plans, FAT/SAT documents, commissioning protocols, risk assessments, and summary reports as needed for multiple projects relating such as containment systems, roller compactors, film coaters and associated HVAC systems.
• Development and/or improvement of procedures, practices, and policies related to computer system validation of major equipment. Monitor and update the Validation Master Plan to ensure that it complies with appropriate regulatory guidelines and standard practices.
• Participate and set maintenance life plans relating to the computer systems associated with major equipment and HVAC systems.
• Utilise electronic validation systems (KNEAT) to complete all validation activities.
• Act as a validation SME in different site projects, as required.
• Work collaboratively with business process owners, technical system owners, and QA validation as needed.
• Experience with Quality systems like Change control, CAPA, and deviations.

Qualifications

At Wood, we are committed to equal opportunities and welcome all talented individuals to consider joining our team. So even if you don't match every statement below but feel you have some of the experience, knowledge or skills needed for this role, we encourage you to apply. It will take all of us working together to deliver solutions to the world's most critical challenges.

What makes you remarkable?

Qualifications / Skills / Experience

• Bachelor of Science or Arts or equivalent experience
• Pharmaceutical Manufacturing and Computerised Systems and Validation
• Experience with ISPE GAMP Computer System Development Life cycle methodology
• Knowledge of Client Server environment, UNIX, NT, Windows, Data communications equipment (Routers, Switches, LAN/WAN, PLC)

Diversity Statement

We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.