Job Description
ARE YOU PASSIONATE ABOUT DRIVING COMPLIANCE, ENSURING SYSTEM INTEGRITY, AND ELEVATING QUALITY STANDARDS? Tentamus North America is searching for a skilled Computer Systems Validation Engineer to lead validation efforts, strengthen regulatory compliance, and support the implementation of high-quality, risk-based IT and laboratory systems. This role is ideal for someone with deep knowledge of cGMP, a strong analytical mindset, and the ability to translate complex technical requirements into compliant, reliable solutions.
If you excel in dynamic environments, enjoy solving challenges that directly impact product quality and patient safety, and thrive at the intersection of technology and regulatory compliance, we want to hear from you!
WHAT YOU'LL DO AS THE CSV ENGINEER The CSV Engineer performs validation services, including but not limited to equipment qualification, method validation, protocol generation and execution, data analysis and reporting; Generating, executing, and reviewing validation protocols and reports for equipment, instruments, utilities, and control systems through: Commissioning, (ERES), VP, FDS, DS, URS, IQ, OQ, PQ, VSR phases. Other duties include:
Validation Documentation & Execution - Author, review, approve, and execute validation documentation, including protocols, summary reports, procedures, and other lifecycle documents.
- Design, implement, and support validation strategies and protocols for products, raw materials, and development projects.
- Provide URS, validation plans, and risk assessments for new systems and equipment introduced to the facility.
- Provide technical support for validation activities associated with Quality Control testing processes.
Compliance, cGMP, and Quality Assurance - Ensure validation studies and related activities comply with cGMP, quality systems, and IT Quality Assurance practices.
- Participate in and support internal and external audits and inspections, including identifying compliance gaps and implementing corrective actions.
- Assess site regulatory compliance status and ensure implementation of CAPA for ongoing inspection readiness.
- Identify, communicate, and manage trends in operational compliance risks, ensuring appropriate CAPA is agreed upon with stakeholders.
- Provide compliance input for internal management reviews and external regulatory inspections.
- Develop and implement quality standards, including SOPs and processes for IT products and services.
Validation Support & Troubleshooting - Support and maintain the validation department's equipment inventory.
- Generate data and reports for validation system evaluation programs.
- Investigate and conduct troubleshooting and root-cause analysis for validation-related incidents and deviations.
- Resolve CAPAs and non-conformances related to validation activities.
Cross-Functional Collaboration & Representation - Partner with Quality Laboratories, QA, and cross-functional teams on validation study execution and quality initiatives.
- Represent equipment qualification and validation programs during client and regulatory audits.
- Utilize compliance expertise to guide program, project, and system owners in applying a risk-based approach to compliant IT solution delivery.
Continuous Improvement & Digitalization - Drive continuous monitoring, improvement, and digitalization of processes, services, and tools by applying LEAN methodologies and automation.
Skills & Technical Competencies - Demonstrate in-depth knowledge of cGMP regulations, quality systems, and IT Quality Assurance practices.
- Maintain strong organizational, documentation, analytical, and problem-solving abilities.
- Be proficient in using Quality Management software and tools.
- Work collaboratively with cross-functional teams to achieve quality and compliance objectives.
SCHEDULE & POSITION This is a full-time, Monday - Friday, hybrid position. Occasional evening and weekend work may be required for performance tests or software rollouts, and domestic travel up to 20% may be necessary for project implementation, collaboration, and/or learning and development purposes. This role primarily operates in an office environment, but we offer flexibility for remote work based on organizational needs. Collaboration with multiple departments and teams is essential.
Our ideal candidate will be located near one of our laboratories in Portland, Oregon, Dallas / Fort Worth, Texas, or Fredericksburg, Virginia. MENTAL & PHYSICAL REQUIREMENTS This role requires regular use of hands and fingers, the ability to reach, talk, and hear, and extended periods of sitting at a desk working on a computer. Specific vision abilities needed include near and far distance, color perception, peripheral vision, and depth perception.
WHAT'S IN IT FOR YOU? This role offers an annual salary between $80,000 - $85,000, a comprehensive and low-cost benefits package including medical, HSA, dental, vision, disability, life insurance, a matching 401(k), paid time off (PTO), and access to an Employee Assistance Program.
QUALIFICATIONS The ideal candidate will be authorized to work in the United States indefinitely and without restrictions or sponsorship, hold a Bachelor's Degree in Chemistry, Laboratory Sciences, Computer Science, or a related field preferred; equivalent experience, post-graduate education, or relevant certifications/licensure considered; other qualifications include:
- 3-5 years of experience in a laboratory, IT Quality Assurance, or related regulated environment, with the ability to perform all essential duties independently.
- Working knowledge of common laboratory equipment and software as well as general pharmaceutical testing processes, raw materials, and quality systems.
- GMP experience strongly preferred.
- Full working knowledge of 21 CFR Part 11, GAMP 5, ALCOA+ and standard industry expectations for computerized system validation.
- Strong understanding of the system validation lifecycle, computer system validation requirements, and data integrity principles.
- Ability to apply concepts from science and engineering to define problems, collect and analyze data, and draw valid conclusions.
- Proficiency with Quality Management tools and documentation practices.
- At least 2 years of professional experience in IT Quality Assurance, including proficiency with IT QA SOPs, Quality Policies, and delivering training to IT and laboratory users.
- Strong problem-solving, project management, and organizational capabilities.
- Ability to manage multiple priorities while balancing short- and long-term objectives.
- Able to work collaboratively in cross-functional and cross-cultural teams, while also making independent decisions when required.
- Excellent oral and written communication skills, with the ability to clearly synthesize and present complex concepts.
ABOUT TENTAMUS Labs for Life® . We are a global network of full-service accredited analytical laboratories providing crucial quality and safety analysis for clients locally, nationally, and beyond using proven methods of chemistry and microbiology. Many of the products you use and consume daily rely on Tentamus labs. With 20 labs in North America and growing (100 globally), we celebrate having talented diverse scientific and service-oriented professionals.
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Job Tags
Full time, Temporary work, Casual work, Work at office, Remote work, Monday to Friday, Afternoon shift,