Payload Accommodation Engineer III at Blue Origin managing payload lifecycle for space technology. Focused on systems engineering practices and customer management in a dynamic environment.
About the role
- Computer Systems Validation Engineer working on meaningful projects in energy transition and hydrogen initiatives. Utilizing technical skills in pharmaceutical manufacturing and validation to support client needs.
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.
Requirements
- 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)
Benefits
- 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
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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