Absorption Systems, a Pharmaron Company, a contract research organization is seeking a candidate for a Software Validation Engineer to support both its Boston, Massachusetts and Germantown, Maryland locations. The Software Validation Engineer maintains all GLP/GMP computer systems in a compliant state. This position actively performs or supports all computerized software and automated equipment validation.
Key Responsibilities:
- Implement and maintain the validation program for computer systems and automated equipment per applicable regulatory guidelines
- Perform computer software Validation/Qualification activities including developing/executing software SDLC (Software Development Life Cycle) documents (URS, Functional Requirements, Risk Assessment Design Specification, IQ, OQ, PQ)
- Work with system and equipment owners and actively manage validation documentation creation and development including GxP Assessments, Validation Plans, Risk Assessments, Requirements/Design/Functional Specifications, Installation Qualification, Operational Qualification and Preventative Qualification Protocols, Reports, and Standard Operating Procedures
- Provide compliance guidance for GxP software updates and releases
- Manage vendor Validation Documentation
- Monitor processes for adherence to established procedures/regulatory compliance
- 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 GxP gaps and provide and execute remediation plan for any identified gaps
- Ensure validation program meets applicable regulatory requirements
- Provide guidance for quality related issues and consult with QA Management to resolve complex quality issues
- Responsible for supporting internal and external inspections as a Subject Matter Expert for Software Validation
- Participate as needed to support internal audits, client audits, supplier audits, regulatory inspections
- Stay current with changes to GxP, including FDA and EU and other regulatory bodies, as well as guidance documents
- Write or revise Standard Operating Procedures as required
- Perform other duties as required
Requirements and Expectations:
- BS or MS degree in information technology or related discipline, or equivalent experience
- 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, 21CFR58, 21CFR210 and 21CFR211
- Excellent technical writing skills with strong attention to detail
- Exceptional written and verbal communication skills
- Ability to plan, schedule and execute Validation Lifecycle deliverables
- Ability to anticipate problems/issues and create contingency plans
- Ability to interact effectively with all levels of personnel within the organization
- About 40% travel will most likely be required and some work remotely.
Benefits
Absorption Systems cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a comprehensive benefits package that meets their personal needs.
About Absorption Systems, a Pharmaron Company
Absorption Systems, founded in 1996, assists pharmaceutical and medical device companies in identifying and overcoming ADMET (Absorption, Distribution, Metabolism, Excretion and Toxicity) barriers in the development of drugs, biologics and medical devices. Additionally, Absorption Systems goes deep into each of those areas, offering in vitro, in situ and in vivo models to assess the properties in question. The company's mission is to continually develop innovative research tools that can be used to accurately predict human outcomes or to explain unanticipated human outcomes when they occur. Absorption Systems has facilities in Exton, PA, San Diego, CA, and Boston, MA to serve customers throughout the world.
Alongside of our enthusiasm for science and research, we have a passion to see each and every one of our employees grow and succeed both personally and professionally. We encourage our employees to continually enhance their ability to contribute to the success of the organization and advance their careers. Absorption Systems is committed to creating an environment where individuals are encouraged to grow and work in collaboration with each other while being passionate about innovation. The professional culture of our organization is a goal oriented environment full of internally driven and motivated professionals. Our company is unique in the fact that there is freedom for autonomy to execute and the ability for each employee to grow in directions that align their individual aspirations with company growth.
Absorption Systems is proud to be an Equal Employment Opportunity and Affirmative Action employer.