3410 IT & Software Developer jobs in the US
Validation Lead - Raritan, NJ
$96,000 - 136,000
Sierra Business Solution LLC
West Somerset Street 42, Raritan
$96,000 - 136,000
Requirements
Must:
- Proven experience in Computer System Validation (CSV)
- Familiarity with software development life cycle (SDLC) and software testing life cycle (STLC)
- Proficient in drafting, reviewing, revising, and maintaining validation documents including Compliance Analysis, Compliance Plan, Change Control Document, User Functional Requirement documents, Risk Assessments, various Test Protocols, and Validation Technical Documentation
- Skilled in creating Standard Operating Procedures (SOP) and Work Instructions (WI)
- Strong knowledge of tools like JIRA, HP-ALM, and qTest
- Understanding of validation testing in agile methodology projects
- Demonstrated knowledge of Agile techniques such as User Stories and Continuous Testing
- Commitment to timely product delivery
- GxP experience is mandatory
- Background in validation support for 21 CFR Part 11 in the pharmaceutical industry
- Experience working within FDA and other regulated pharmaceutical sectors
- Excellent verbal and written communication skills with the ability to interact with diverse stakeholders
- Self-motivated and proactive with strong attention to detail
- Ability to handle pressure with dynamism
- Competency in CSV skills with organizational abilities to meet tight deadlines
- Capability to work collaboratively and independently
- Experience of 10+ years in relevant fields
Responsibilities
- Conduct meetings with system users to understand project scope
- Participate in business requirements discussions to draft relevant SDLC and CSV qualification documentation
- Develop strategies for validation, qualification, migration, and verification of software
- Execute validation strategies in accordance with quality assurance SOPs
- Offer validation recommendations to stakeholders when necessary
- Manage relationships with customers, technical teams, quality assurance personnel, and testing teams to meet validation expectations
- Ensure all SDLCCSV qualification activities are on track
- Generate, review, and maintain Computerized Systems lifecycle documentation including risk assessments, user requirement specifications, and validation plans
- Communicate findings to both technical and non-technical audiences
- Liaise with project teams globally
- Lead the validation initiatives and maintain high standards of quality throughout the process
- Work towards stringent project deadlines
Description
We are seeking a Validation Lead with a strong background in AI to join our team. This role is based in Raritan, NJ, and offers remote opportunities for candidates in Canada. We pride ourselves on fostering a collaborative environment where innovation and commitment to excellence are valued. Our team is focused on delivering high-quality validation solutions in the pharmaceutical industry, emphasizing adherence to regulatory standards. We offer competitive benefits and professional growth opportunities.
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