Senior Validation Specialist
2 months ago
Position: Quality CSV SME
Duration: 6+ months
Location: South San Francisco, CA
JOB DESCRIPTION
Quality CSV SME
JOB DESCRIPTION Our client is a small Biotech research company. They are currently seeking a Quality CSV SME to come on-site 3 days a week in South San Fran. This role is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.
The Role:
Reporting to the Director, QA Computer System Validation (CSV), the Associate Director, CSV is responsible for compliance oversight of computer system validation projects as part of the quality assurance team. This role will share strategic responsibility for the QA CSV function to support cross-functional and QA goals for GXP systems and deliver results for corporate initiatives, as well as independently drive and own multiple complex CSV-related projects in partnership with multiple cross-functional leaders.
Key Responsibilities:
• Implement CSV Strategies: Assist in the execution of GxP computer system validation lifecycle and QA-CSV strategies.
• Resource Management: Lead internal and contract resources to ensure effective CSV support for business needs.
• Risk Assessment: Collaborate with functional teams to manage risk assessments and develop mitigation plans.
• Documentation Oversight: Contribute to the review and approval of CSV documentation, including specifications and validation protocols.
• Audit Participation: Engage in vendor assessments and lead routine and complex audits of internal processes and partners.
• Compliance Guidance: Provide CSV compliance support to QA and other GxP functions, identifying issues and facilitating continuous improvement.
• Inspection Readiness: Prepare for regulatory inspections and assist with responses to findings.
• Policy Development: Update and create relevant CSV-related policies, procedures, and templates.
• Process Improvement: Identify opportunities for enhancements based on industry best practices and regulatory requirements.
Required Skillset
Biopharmaceutical Experience
CSV Expertise
Tracelink and RIM (Strong Knowledge)
GxP Systems Experience
Strong Communication Skills
Thanks,
Raja
-
Senior Validation Specialist
4 weeks ago
South San Francisco, California, United States LS Solutions Inc Full timeJob Title: Senior Validation SpecialistLS Solutions Inc is seeking a Senior Validation Specialist to join our team.Job Summary:We are looking for a highly skilled and experienced Senior Validation Specialist to lead our computer system validation (CSV) efforts. The ideal candidate will have a strong background in GxP systems, CSV expertise, and excellent...
-
Senior Validation Specialist
4 weeks ago
San Francisco, California, United States SciPro Inc. Full timeSenior Validation EngineerJob Summary:The Senior Validation Engineer will be responsible for leading key validation activities, including Commissioning and Qualification, Performance Qualification (PQ), Cleaning Validation (CV), Process Validation (PV), and Revalidation (RV). This role requires a strong understanding of cGMP regulations and experience in...
-
Senior Data Validation Specialist
4 weeks ago
San Diego, California, United States Syntricate Technologies Full timeJob Title: Senior Data Validation SpecialistLocation: Not SpecifiedDuration: ContractJob Description:Data Validation Lead with expertise in SQL, Testing, and Automation using Python and Selenium. Strong understanding of JIRA and data validation processes.Responsibilities:Lead data validation efforts to ensure high-quality dataDevelop and implement testing...
-
Senior Care Specialist
4 weeks ago
San Francisco, California, United States Integral Senior Living Full timeSenior Care Specialist OpportunityIntegral Senior Living is seeking a compassionate and dedicated Senior Care Specialist to join our team at Sagebrook Senior Living. As a Senior Care Specialist, you will play a vital role in providing exceptional care and support to our residents, ensuring their physical, emotional, and social...
-
Certified Nursing Assistant
3 weeks ago
San Diego, California, United States Senior Living Recruiting Specialist Full timeAs a Certified Nursing Assistant with Senior Living Recruiting Specialist, you will play a vital role in providing compassionate care to our residents. Our senior living community relies on dedicated professionals like you to ensure the well-being of our residents.We offer a stable and long-term career with opportunities for growth and development. Our CNA's...
-
Senior Computer System Validation Specialist
3 weeks ago
South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full timeJob SummaryWe are seeking a highly skilled Senior Computer System Validation Specialist to join our team at Katalyst HealthCares & Life Sciences. As a key member of our IT Computerized System Validation (CSV) Department, you will be responsible for leading and directing GxP computerized system validation projects in compliance with cGMP, CFR Part and...
-
Senior Care Specialist
3 weeks ago
San Francisco, California, United States Sagebrook Senior Living at San Francisco Full timeJob OverviewSagebrook Senior Living at San Francisco is seeking a compassionate and dedicated Senior Care Specialist to join our team. As a Senior Care Specialist, you will play a vital role in providing exceptional care and support to our residents, ensuring their dignity and independence are maintained at all times.Key Responsibilities:Provide hands-on...
-
Senior Care Specialist
3 weeks ago
San Francisco, California, United States Sagebrook Senior Living at San Francisco Full timeAbout the Role:Sagebrook Senior Living at San Francisco is seeking a compassionate and detail-oriented Senior Care Specialist to join our team. As a Senior Care Specialist, you will play a vital role in providing exceptional care and support to our residents, ensuring their physical and emotional well-being.Responsibilities:Provide hands-on care and physical...
-
Computer Systems Validation Specialist
3 weeks ago
San Francisco, California, United States Katalyst Healthcares and Life Sciences Full timeJob Title: Computer Systems Validation SpecialistAbout the Role:Katalyst Healthcares and Life Sciences is seeking a skilled Computer Systems Validation Specialist to join our team. As a key member of our validation team, you will be responsible for ensuring the compliance of our computerized systems with regulatory requirements.Key Responsibilities:Apply...
-
Certified Nursing Assistant
4 weeks ago
San Diego, California, United States Senior Living Recruiting Specialist Full timeMake a Difference in the Lives of SeniorsWe are seeking compassionate and dedicated Certified Nursing Assistants (CNAs) to join our team at Senior Living. As a CNA, you will play a vital role in providing exceptional care and support to our residents, helping them maintain their independence and dignity.What We OfferA competitive hourly wage of $17-$19, with...
-
Senior Physician Specialist
4 weeks ago
San Francisco, California, United States City and County of San Francisco Full timeJob SummaryWe are seeking a highly skilled and experienced Senior Physician Specialist to join our team at the City and County of San Francisco. As a Senior Physician Specialist, you will be responsible for providing medical expertise and leadership in the development and implementation of policies, methods, and procedures within the specialty area.Key...
-
Senior Validation Specialist
4 weeks ago
South Jordan, Utah, United States BEPC Inc. - Business Excellence Professional Consulting Full timeJob Opportunity at BEPC Inc.We are seeking a highly skilled Validation Engineer to join our team at BEPC Inc. - Business Excellence Professional Consulting.Job Summary:As a Validation Engineer, you will be responsible for performing equipment validations and process validations (IQ, OQ, PQ) to ensure compliance with FDA regulations.Key...
-
Validation Specialist
4 weeks ago
San Mateo, California, United States Fladger Assoc. Inc. Full timeJob DescriptionFladger Assoc. Inc. is seeking a skilled Validation Specialist to join our team in Santa Monica, CA.As a Validation Specialist, you will be responsible for performing the validation of computer systems, including developing validation master plans, preparing protocols, analyzing test results, and preparing technical reports.Key...
-
Senior Validation Engineer
3 weeks ago
South Plainfield, New Jersey, United States Katalyst HealthCares & Life Sciences Full timeJob Summary: We are seeking a highly skilled Senior Validation Engineer to join our team at Katalyst HealthCares & Life Sciences. As a key member of our team, you will be responsible for ensuring the integrity of our data and systems, while maintaining compliance with regulatory requirements. Responsibilities: Perform data integrity risk assessments and...
-
Senior Validation Engineer
3 weeks ago
San Jose, California, United States MILLENNIUMSOFT Full timeJob Title: Senior Validation EngineerWe are seeking a highly skilled Senior Validation Engineer to join our team at Millenniumsoft. As a Senior Validation Engineer, you will be responsible for performing process, equipment, and software validation activities, including gathering historical data for product manufacture, analyzing data using statistical...
-
Senior Physician Specialist
3 weeks ago
San Francisco, California, United States City and County of San Francisco Full timeJob SummaryThe City and County of San Francisco is seeking a highly skilled Senior Physician Specialist to join our team. As a Senior Physician Specialist, you will be responsible for providing medical expertise and leadership in various specialties, including but not limited to, family medicine, internal medicine, surgery, pediatrics, and obstetrics and...
-
Validation Specialist
4 weeks ago
San Jose, California, United States netPolarity, Inc. (Saicon Consultants, Inc.) Full timeJob Title: Senior Validation EngineerLocation: San Jose, CADuration: 6 month contractWe are seeking a highly skilled Senior Validation Engineer to join our industry-leading engineering team at netPolarity, Inc. (Saicon Consultants, Inc.).The successful candidate will be part of a team responsible for developing validation and characterization solutions for...
-
Validation Specialist
3 weeks ago
San Francisco, California, United States PSC Biotech Full timePSC Biotech is a leading provider of life sciences services, dedicated to ensuring the highest standards of quality and regulatory compliance in the development, manufacturing, and distribution of healthcare products.As a Validation Engineer at PSC Biotech, you will play a critical role in driving project success by supporting validation planning,...
-
Licensed Practical Nurse
4 weeks ago
South Boston, United States Commonwealth Senior Living Full timeSenior Care Specialist OpportunityWe are seeking a compassionate and skilled Licensed Practical Nurse (LPN) to join our team at Commonwealth Senior Living. As a Senior Care Specialist, you will play a vital role in providing high-quality care to our residents, working closely with our Resident Care Director to ensure the best possible...
-
Senior Validation Engineer
4 weeks ago
San Jose, California, United States Trilyon, Inc. Full timeJob Title: Senior Validation EngineerWe are seeking a highly skilled Senior Validation Engineer to join our team at Trilyon, Inc. in San Jose, CA.Job Summary:The successful candidate will be part of a dynamic engineering team responsible for developing validation and characterization solutions for cutting-edge transceivers. Key responsibilities...