We are searching for a Software Validation Engineer to join our team in Germantown, MD.
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:
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 as required
Perform other duties as required
Requirements and Expectations:
BS or MS degree in information technology or related discipline, or equivalent
experience
Five years 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
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
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