|Company Name:||System One|
|Job Location:||Medford, MA|
|Job Posted Date:||20-04-2023|
System One is seeking a Software Validation Engineer in Medford, MA. Please take a moment to read the job post below if you are interested:
Title: Software Validation Engineer
Location: Woburn, MA. area
Start Date: ASAP!
Duration: Direct Hire
Hours: Mon-Fri; 8am-5pm
- Extensive hands-on software validation experience in the biotechnology or pharmaceutical industries including writing, executing, and summarizing validation protocols and testing procedures
- BS or MS degree in information technology or related discipline, or equivalent experience
- Broad and in-depth knowledge of computerized systems and regulatory requirements, and current validation approaches to evaluate computerized systems
- Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV)
- Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11, 21CFR58, 21CFR210 and 21CFR211
- Ability to plan, schedule and execute Validation Lifecycle deliverables
- Willingness to travel 5-10% of the time to support sites in Maryland
- Implement and maintain the validation program for computer systems and automated equipment per applicable regulatory guidelines
- Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment Design Specification, IQ, OQ, PQ)
- Provide compliance guidance for GxP software updates and releases
- Manage vendor Validation Documentation
- Monitor processes for adherence to established procedures/regulatory compliance
- Work with system and equipment owners and actively manage validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Preventative Qualification Protocols, Reports, and Standard Operating Procedures
- Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards
- Review existing Computerized System Validation (CSV) reports and identify any GxP gaps and provide and execute remediation plan for any identified gaps
- Ensure validation program meets applicable regulatory requirements
- Provide guidance for quality related issues and consult with QA Management to resolve complex quality issues
- Responsible for supporting internal and external inspections as a Subject Matter Expert for Software Validation
- Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections
- Stay current with changes to GxP, including FDA and EU and other regulatory bodies, as well as guidance documents
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, and MOUNTAIN, LTD., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
Getting the Software Validation Engineer designation comes with some responsibilities. It would be a wise idea to take a few minutes to learn more about it so you can make an informed decision.
Applicants must meet the above-mentioned requirements in order to qualify for consideration to work as a Software Validation Engineer.
By clicking on the apply now button, you will be redirected to the official recruitment website where you can fill out your application.