Pharmaron
Software Validation Engineer (GXP)
Pharmaron, Exton, Pennsylvania, United States, 19341
Position : Software Validation Engineer (GXP)
Department:
Quality Assurance
FLSA Status:
Exempt
Location:
Exton, PA (ON-SITE)
Job Overview:
We are seeking a Software Validation Engineer to join our team in Exton, PA. In this critical role, you will be responsible for maintaining all GLP/GMP computer systems in a compliant state and ensuring the validation of computerized software and automated equipment meets regulatory requirements. You will oversee the entire validation lifecycle, provide technical expertise, and support compliance efforts across various projects.
Additional tasks: Lead and execute validation activities throughout all stages of the validation lifecycle, including: Development of validation plans, risk assessments, and protocols. Execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Compilation and analysis of process validation data. Develop and maintain validation documentation, including Regulatory Assessments, Validation Plans, Risk Assessments, and Standard Operating Procedures (SOPs). Perform and manage Computer Software Validation (CSV), including: Creating and executing Software Development Life Cycle (SDLC) documents (e.g., URS, Functional Requirements, Design Specifications, Trace Matrix). Ensuring compliance with GLP software updates, releases, and regulatory standards. Identify and remediate regulatory gaps in existing Computerized System Validation (CSV) documentation to ensure compliance with regulatory requirements. Act as a Subject Matter Expert (SME) for Software Validation during internal audits, client audits, supplier audits, and regulatory inspections. Stay updated on industry standards (FDA, EU, GAMP, etc.) and provide technical expertise to ensure compliance with evolving regulations. Write or revise Standard Operating Procedures (SOPs) as needed. What We're Looking For:
Bachelor's or Master's degree in IT or related field, or equivalent experience. Minimum 5 years of hands-on software validation experience in biotechnology or pharmaceutical industries. Experience in GMP Life Sciences environments with expertise in Computer Systems Validation (CSV). Strong knowledge of global regulatory requirements (GAMP, ICH guidelines, USP, 21 CFR Part 11/58). Proficient in writing, executing, and summarizing validation protocols and testing procedures. Excellent technical writing, communication, and organizational skills. Ability to plan and execute validation lifecycle deliverables, anticipate issues, and develop contingency plans. Strong interpersonal skills to collaborate effectively across all levels of the organization.
Why Pharmaron?
Pharmaron stands as a leading force in the life sciences industry, offering premier R&D services to partners across the globe. With a workforce of over 20,000 professionals and operations spanning China, the U.S., and the U.K., Pharmaron is committed to delivering innovative R&D solutions that drive advancements in healthcare.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Comprehensive benefit package:
As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you will have access to an Employee Assistance Program to support you in work and life. The expected salary range for this role in Exton, PA, is $83,000 to $103,000. The final offer will depend on various factors, including the candidate's experience and expertise in the role and industry, specific skillset, and educational background.
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
Got Questions?
If you have any questions about the role or our company, do not hesitate to reach out. We are here to help!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#LI-MC1
Department:
Quality Assurance
FLSA Status:
Exempt
Location:
Exton, PA (ON-SITE)
Job Overview:
We are seeking a Software Validation Engineer to join our team in Exton, PA. In this critical role, you will be responsible for maintaining all GLP/GMP computer systems in a compliant state and ensuring the validation of computerized software and automated equipment meets regulatory requirements. You will oversee the entire validation lifecycle, provide technical expertise, and support compliance efforts across various projects.
Additional tasks: Lead and execute validation activities throughout all stages of the validation lifecycle, including: Development of validation plans, risk assessments, and protocols. Execution of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ). Compilation and analysis of process validation data. Develop and maintain validation documentation, including Regulatory Assessments, Validation Plans, Risk Assessments, and Standard Operating Procedures (SOPs). Perform and manage Computer Software Validation (CSV), including: Creating and executing Software Development Life Cycle (SDLC) documents (e.g., URS, Functional Requirements, Design Specifications, Trace Matrix). Ensuring compliance with GLP software updates, releases, and regulatory standards. Identify and remediate regulatory gaps in existing Computerized System Validation (CSV) documentation to ensure compliance with regulatory requirements. Act as a Subject Matter Expert (SME) for Software Validation during internal audits, client audits, supplier audits, and regulatory inspections. Stay updated on industry standards (FDA, EU, GAMP, etc.) and provide technical expertise to ensure compliance with evolving regulations. Write or revise Standard Operating Procedures (SOPs) as needed. What We're Looking For:
Bachelor's or Master's degree in IT or related field, or equivalent experience. Minimum 5 years of hands-on software validation experience in biotechnology or pharmaceutical industries. Experience in GMP Life Sciences environments with expertise in Computer Systems Validation (CSV). Strong knowledge of global regulatory requirements (GAMP, ICH guidelines, USP, 21 CFR Part 11/58). Proficient in writing, executing, and summarizing validation protocols and testing procedures. Excellent technical writing, communication, and organizational skills. Ability to plan and execute validation lifecycle deliverables, anticipate issues, and develop contingency plans. Strong interpersonal skills to collaborate effectively across all levels of the organization.
Why Pharmaron?
Pharmaron stands as a leading force in the life sciences industry, offering premier R&D services to partners across the globe. With a workforce of over 20,000 professionals and operations spanning China, the U.S., and the U.K., Pharmaron is committed to delivering innovative R&D solutions that drive advancements in healthcare.
Collaborative Culture:
You will thrive in our inclusive and collaborative environment, where teamwork and innovation go hand in hand. Here, your voice matters, and your contributions make a real impact. "Employees Number One" and "Clients Centered" are the core cultural values at Pharmaron. Our culture, which sets Pharmaron apart from other organizations, has evolved from our deep commitment to our employees, partners, and collaborators.
Comprehensive benefit package:
As part of our commitment to your well-being, we offer a comprehensive benefits package, including medical, dental, and vision insurance with significant employer contributions. Planning for your future is made easier with our 401k plan and employer match. Plus, you will have access to an Employee Assistance Program to support you in work and life. The expected salary range for this role in Exton, PA, is $83,000 to $103,000. The final offer will depend on various factors, including the candidate's experience and expertise in the role and industry, specific skillset, and educational background.
How to Apply:
Ready to seize this incredible opportunity? Join us at Pharmaron and be part of a dynamic team driving innovation and excellence in biopharmaceutical research and development. Apply online today!
Got Questions?
If you have any questions about the role or our company, do not hesitate to reach out. We are here to help!
As an Equal Employment Opportunity and Affirmative Action employer, Pharmaron values diversity and inclusion in the workplace, fostering an environment where all individuals are empowered to succeed. Join us in our mission to make a difference in the world of life sciences.
#LI-MC1