Software Validation Engineer

Position: Software Validation Engineer

Location: Germantown, MD

Salary: $80,000-$100,000

Pharmaron is looking for our newest Software validation Engineer at our Germantown, MD facility! If you're craving a role that offers challenges, growth, and meaningful impact, then this is the opportunity you've been waiting for.

Job Overview:

As a Software Validation Engineer, you will develop and maintain the Computer Software Validation Program, actively performing and supporting all computerized software validation activities within the GLP laboratories. Utilizing your excellent communication and technical writing skills, you will oversee all stages of project plans. Additionally, your ability to anticipate potential issues and apply your knowledge and skills will enable you to create effective contingency plans.

Responsibilities:

• Actively manage and participate in the execution of all stages of the validation life-cycle, including development of project design, generation of validation plans for larger projects, performance of risk assessment of validation requirements, compilation of validation protocols and reports, collation and analysis of process validation data, and witnessing of certain validation activities
• Work with System and Equipment Owners on validation documentation creation and development including Regulatory Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Performance Qualification Protocols, Reports, and Standard Operating Procedures
• Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Trace Matrix, Risk Assessment, Design Specification, IQ, OQ, PQ)
• Provide compliance guidance for GLP software updates and releases
• Manage vendor software validation documentation
• Provide technical expertise, interpretation and direction to management and user departments to assure compliance with regulatory requirements, company policies and standards
• Review existing Computerized System Validation (CSV) reports and identify any Regulatory gaps and provide and execute remediation plans for any identified gaps
• Ensure the computer software validation program meets applicable regulatory requirements
• Maintain awareness of activities by routine direct observation of testing laboratories and frequent interaction with operations staff to provide perspective on routine operations and support systems
• Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections as a Subject Matter Expert for Software Validation
• Stay current with changes to CSV industry standards, including FDA and EU and other regulatory bodies, as well as guidance documents
• Write or revise Standard Operating Procedures

What We're Looking For:

• BS or MS degree in information technology or related discipline, or equivalent experience
• Have extensive hands-on software validation experience in the biotechnology or pharmaceutical industries including writing, executing, and summarizing validation protocols and testing procedures
• Broad and in-depth knowledge of computerized systems and regulatory requirements, and current validation approaches to evaluate computerized systems
• Experience working in a GxP Life Sciences environment for Computer Systems Validation (CSV)
• Strong knowledge of global regulatory requirements for validation, including current GAMP, ICH guidelines and USP, 21CFR11 and 21CFR58
• Ability to plan, schedule and execute Validation Lifecycle deliverables

Why Pharmaron?

Pharmaron is a premier service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities and established a broad spectrum of research, development, and manufacturing service capabilities throughout the entire drug discovery, preclinical, and clinical development process across multiple therapeutic modalities, including small molecules, biologics, and CGT products. With over 21,000 employees and operations in the U.S., the U.K. and China. Pharmaron has an excellent track record in delivering R&D solutions to its partners in North America, Europe, Japan, and China.

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.

Benefits: As part of our commitment to your well-being, we offer a comprehensive benefits package:

• Insurance including Medical, Dental & Vision with significant employer contributions
• Employer-funded Health Reimbursement Account
• Healthcare & Dependent Care Flexible Spending Accounts
• 100% Employer-paid Employee Life and AD&D Insurance, Short and Long Term Disability Insurance
• 401k plan with generous employer match
• Access to an Employee Assistance Program

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!

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.

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