CSV Engineer
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Job Description
We're ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we've been helping our clients develop products that are changing the world, whether that's by shaping the future of space exploration, saving lives with medical devices that set a new standard of care, or creating the fully autonomous electric taxi of tomorrow. Our team of more than 600 people works across industries including aerospace, medical devices and life sciences, unmanned systems and robotics, automotive OEM and tier 1 suppliers, commercial vehicle, electric vehicles, rail, and more. Our offices across the US have different industry focuses and engage with our clients in different ways, ranging from working on-site at client facilities to performing product development at our delivery centers.
ALTEN Group, our parent company, has been a leader in engineering and information technology for more than 30 years. ALTEN Group operates in 30 countries across Europe, North America, Asia, Africa and the Middle East and employs more than 36,000 people, 88% of whom are engineers. The company covers the whole development cycle and offers a choice of service levels, from technology consulting to complete project outsourcing.
When you join ALTEN Technology USA, you join a group of people passionate about collaborating to solve some of the world's most technical engineering challenges. Our success is tied to taking care of our employees by building relationships and providing opportunities for mentorship and career growth. We offer comprehensive benefits for all full-time employees, including medical, dental, and vision insurance; a 401(k) plan with employer matching; paid time off (PTO); paid parental leave; and mentorship to help you take your career to the next level. You don't have to take our word for it that we are a great place to work we were named on the 2023 Top Workplaces list thanks to feedback from our proud employees.
The Computer Systems Validation Engineer is responsible for the execution of computerized system and spreadsheet validation, data integrity assessments, and remediation. The individual ensures that GxP systems meet intended uses and complies with applicable regulations, current industry practices, and internal procedures. The candidate will be responsible for supporting the asset lifecycle (concept to retirement) of existing and new computerized systems in the manufacturing equipment and QC lab software systems (e.g., LIMS and Empower CDS), and facilities applications (e.g., BMS and EMS).
Responsibilities:
- Support CSV and DI remediation activities which also includes spreadsheet validation.
- Help support CSV/DI change controls and new CSV/DI equipment implementations.
- Generate, participate, or review lifecycle documentation - such as user requirements, functional specifications, functional requirements, configuration specification, project plans, IQ/OQ/PQ protocols, GxP criticality assessments, Electronic Records
- Electronic Signature assessments, trace matrix requirements, deviations, validation summary reports, and system use documentation (system admin, user admin procedures).
- Aid in the development of Operational phase documentation for systems such as configuration management, backup/archive, business continuity plans, disaster recovery plans, incident management, system administration, patch management, etc.
Requirements:
- 5+ years' experience with computer systems validation in relation to Biologics manufacturing equipment and processes, as well as utilities, and facilities.
- Experience in writing operational phase documentation and program-level related documentation.
- Experience with Validation lifecycle documentation (URS, FS, CS, ERES Assessment, DI Assessment, IQ, OQ, etc.)
- Proven ability to work with cross-functional teams to deliver projects on time.
- Experience with Quality Systems (Change Controls, Investigations, CAPAs)
- Technical and fundamental understanding of ISPE GAMP 5, Data Integrity, USP 1058
- Regulatory understanding of 21 CFR Parts 11, 210, 211, 820 requirements, EudraLex Annex 11, Data Integrity, ICH Q7A, Q9 requirements
- Excellent written and verbal communication skills.
- Excellent technical writing skills
- Strong interpersonal skills and the ability to work in a team environment.
- Flexible and adaptable to changing priorities with strong organizational skills.
ALTEN Technology is an Equal Opportunity Employer. Our Policy is to extend opportunities to qualified applicants and employees on an equal basis regardless of an individual's age, race, color, sex, religion, national origin, disability, sexual orientation, gender identity/expression or veteran status.
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