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Validation Engineer I
PSC Biotech CorporationValidation Engineer I supporting computer systems validation and product releases for PSC Biotech’s life-sciences clients. Testing regulated systems, writing validation documentation, and ensuring compliance.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in system validation and compliance with industry standards, with strong technical writing skills and a foundational understanding of risk-based validation processes. Capable of collaborating with cross-functional teams and managing multiple projects effectively while ensuring product excellence.
Highest-signal resume keywords
System ValidationTechnical WritingRisk-Based ValidationClinical Trial SoftwareSoftware Development Cycle
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
System TestingValidation DocumentationRequirements SpecificationsTest ScriptsTrace MatricesChange Control RequestsTroubleshootingAttention to DetailQuality AssuranceProject Management
Soft Skills
CommunicationInterpersonal SkillsTime ManagementAdaptabilityCollaboration
Industry Keywords
Regulatory RequirementsValidation ProceduresCross-Functional TeamsProduct Release ProcessesTechnical Lifecycle Documentation
About the role
Key responsibilities & impact- Support system validation and product release processes
- Ensure compliance with industry standards and regulatory requirements
- Contribute to the development and improvement of validation procedures
- Drive overall product excellence
- Collaborate with cross-functional teams and external clients on project requirements
- Conduct thorough testing for system functionality and reliability using a risk-based validation approach
- Support planning, development, and implementation of computer systems validation documentation
- Write and execute validation documentation, including requirements specifications, test scripts, summary reports, and trace matrices
- Initiate and oversee system CSV change control requests and associated validation documentation
- Identify and troubleshoot potential risks and implement required solutions
- Participate in team meetings and provide project progress updates
- Travel as needed for project assignments and client engagements
- Perform additional responsibilities as required
Requirements
What you’ll need- Bachelor's degree in related engineering discipline
- Entry-level position
- Prior internship or project experience in computer systems/software testing and validation
- Basic understanding of validation processes and risk-based approach
- Familiarity with clinical trial software
- Knowledge of the Software Development Cycle preferred
- Excellent technical computer skills
- Advanced technical writing skills
- Familiarity with technical lifecycle documentation in regulated industries
- Strong attention to detail and commitment to quality
- Excellent communication and interpersonal skills
- Excellent time management skills and ability to manage multiple projects effectively
- Willingness and ability to travel as needed for project assignments and client engagements
- Ability to adapt to different locations, cultures, and work environments
- Must be authorized to work in U.S.
- No C2C at this time
Benefits
Comp & perks- Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
- Insurance options for Employee Assistance Programs, Basic Life Insurance, Long Term Disability and more
- 401(k) and 401(k) matching
- PTO, Sick Time, and Paid Holidays
- Education Assistance
- Pet Insurance
- Fitness Benefits (Membership discounts and other perks/services at qualifying gyms like Anytime Fitness, 24-Hour Fitness, and more)
- Financial Perks and Discounts
- Compensation and benefits structure that rewards employees
- Tools to help employees grow and learn
- Coaching and professional development opportunities