CSV Engineer, Validation Engineer
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Validation Engineer responsible for authoring and executing CSV documentation for life science clients. Collaborating with cross-functional teams and ensuring compliance with industry standards.
Responsibilities:
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader
- Running test scripts and documenting results
- Documenting impact and risk assessments as part of a team
- Completing user interface testing, software verification, and complete alarm testing on automated systems
- Developing, reviewing, and executing testing documentation
- Making recommendations for design or process modification based on test results when executing test scripts
- Maintaining clear, detailed records qualification and validation
Requirements:
- Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical field
- 3+ years of hands-on Computer System Validation (CSV) experience in a regulated pharmaceutical or biotechnology environment
- Working knowledge of cGMP regulations, including 21 CFR Part 11 and EU Annex 11, and application of GAMP 5 principles across the system lifecycle
- Experience supporting validation documentation and testing activities (URS, FDS, risk assessments, IQ/OQ/PQ) and managing deviations and change controls
- Ability to collaborate effectively with cross-functional teams (Operations, Quality, Engineering, IT, etc.)
Benefits:
- High growth potential and fast-paced organization with a people-focused culture
- Competitive pay plus performance-based incentive programs
- Company-paid Life, Short-Term, and Long-Term Disability Insurance.
- Medical, Dental & Vision insurances
- FSA, DCARE, Commuter Benefits
- Supplemental Life, Hospital, Critical Illness and Legal Insurance
- Health Savings Account
- 401(k) Retirement Plan (Employer Matching benefit)
- Paid Time Off (Rollover Option) and Holidays
- As Needed Sick Time
- Tuition Reimbursement
- Team Social Activities (We have fun!)
- Employee Recognition
- Employee Referral Program
- Paid Parental Leave and Bereavement
Similar Jobs
Nuclear Engineer
Engineer - Nuclear-Level 2 responsible for design modifications in nuclear power plants. Overseeing multi-disciplinary system modifications while ensuring safety and regulatory compliance.
Senior Mainframe z/OS Engineer
Senior Mainframe Engineer handling customer environments and solving technical issues. Working remotely while contributing to FNTS's managed services engineering team.
Senior IAM Engineer
IAM Engineer leading transition and ongoing management of enterprise IAM program at Lanteris Space Systems. Responsible for establishing IAM standards and securing cloud and on-prem access.
Project Engineer
Project Engineer supporting sales, design, and commissioning of electrical systems for ABB's Electrification Smart Power Division. Involves compliance and technical coordination with stakeholders.
Associate Server Tech Services Engineer
Associate Server Tech Services Engineer ensuring server health and infrastructure availability through remote diagnostics and collaboration across global teams.
Associate Microgrid Engineer
Microgrid Design Engineer developing DER solutions at Honeywell for C&I projects. Collaborating with engineers to enhance energy efficiency and sustainability goals.
Mission Assurance Engineer
Mid-Level Mission Assurance Engineer supporting corporate quality management and quality assurance processes. Collaborating with multiple teams to ensure standardized quality practices across programs.
Installations Engineer, Level I-II
Installation Engineer at Leo Cancer Care responsible for customer-facing installations and maintenance of complex medical devices. Involves international travel and collaboration with global teams.
Senior Signal Integrity Engineer
Senior Signal Integrity Engineer ensuring performance and reliability of high-speed hardware designs at General Motors. Collaborating with teams and optimizing design processes for next-generation automotive systems.
Context Engineer
Context Engineer at CapIntel responsible for integrating LLMs into the core platform with a focus on reliability. Collaborating with various teams to enhance advisor and client experience.
Chief Engineer
Chief Engineer leading development of innovative solutions for DoD/National Security. Supporting contract delivery, business development, proposal development with comprehensive technical expertise.
Principal Software Engineer, Platform
Principal Software Engineer developing foundational systems supporting engineering operations at Cozey. Designing and maintaining infrastructure for efficient e-commerce processes.
Engenheiro de Dados – Sênior
Senior Data Engineer responsible for developing high-performance data pipelines in Brazil. Collaborating with data scientists and analysts in a complex and dynamic environment.
Senior SQL Engineer
SQL Engineer developing and maintaining T-SQL queries and reports for international projects. Collaborating on code reviews, documentation, and performance enhancements in a remote setting.
Release Train Engineer
Agile Release Train Engineer overseeing program-level delivery and agile maturity for healthcare revenue cycle solutions at Ensemble. Leading cross-team collaboration and continuous improvement across multiple teams.
Identity and Access Management Engineer III, Development Experience Required
Identity and Access Management Engineer III focusing on SailPoint IdentityNow for IAM technologies. Evaluating complex IAM issues and providing technical leadership in strategic design.
Engenheiro NoSQL
NoSQL Engineer engaging in database administration and troubleshooting with Extractta's clients and teams. Focus on optimizing performance and ensuring system availability.
Senior Human Factors Engineer
Senior Human Factors Engineer at Aptive optimizing usability and performance for federal products. Leveraging extensive experience to drive innovation and improve user-centric solutions.
Chief Engineer – Oil Chemical Tanker
Chief Engineer position at Columbia Shipmanagement responsible for operation and maintenance of engines room. Requires STCW certifications and experience with electronic engines and cargo pump systems.
Controls Engineer II
Controls Engineer II at Prime Controls developing training on industrial control systems and evaluating new technologies for project delivery teams. Fostering high-quality professional services for customers.