Sr. Computer Software Validation Engineer

Location: Pittsburgh

Job Type: Contract to Hire

Primary Function: Responsible for software and hardware computer system validation projects. Ensure that all software and systems validations are complete by developing, authoring, and reviewing quality system documentation. Provide leadership and Subject Matter Expertise (SME) on software validation projects to streamline validation processes, procedures and plans that align with current industry standards.

Large emphasis on the following two skills: Provide leadership and Subject Matter Expertise (SME) on software validation projects to streamline validation processes, procedures and plans that align with current industry standards. • Must be able to clearly write validation plans and validation summary reports that defines strategy and deliverables with justification commensurate to system complexity and risk.

Essential Job Functions/Duties:  Lead, initiate, coordinate and execute projects to ensure the successful completion of CSV. • Independently accountable for software validation projects. • Develop, author, and complete quality system documentation and develop Standard Operating Procedures for performance of computer system validation. • Provide software validation subject matter expertise to developers of User Requirement Specs, Functional/Design Specs, Project Plans, Project Charter, Program Plans. • Provide software validation subject matter expertise to ensure that Commercial Off-The-Shelf (COTS), COTS with configurations and in-house developed software/systems validation are complete and in an auditable state. • Provide software validation subject matter expertise to ensure that cloud-based Software as a Service (SaaS) projects with external configurations and validation deliverables are complete and in an auditable state. • Develop, or lead development of, Validation Plans, System Analysis/Assessments, Risk Analysis, Requirement Traceability Matrix, IT Change Management, IOQ/PQ Protocols/Reports and Validation Summary Reports. • Responsible for execution of IQ, OQ, PQ, Trace Matrix, and Summary Reports; execution may include physically being present in laboratories or manufacturing areas.

Knowledge, Skills, and Abilities General Skills & Abilities:  Must have effective verbal, written and interpersonal skills. • Must be able to clearly write validation plans and validation summary reports that defines strategy and deliverables with justification commensurate to system complexity and risk. • Maintain regular and punctual attendance. • Must maintain company quality and safety standards. • Ability to work in collaborative and independent work situations and environments with minimal supervision. • Maintain composure and competence under stressful situations; demonstrate flexibility and adaptability. • Trainability. • Strong interpersonal skills resulting in an exceptional rapport with people. Proven success in initiating, promoting, and maintaining strong interpersonal relations. • Able to prioritize and operate proactively. • Capable of handling multiple responsibilities and/or projects. • Must demonstrate critical thinking and proven problem-solving skills. • Demonstrates critical thinking and ability to execute goals set by the organization and Department Manager. Computer, Technology, and Technical Skills & Abilities • Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook. • In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP). • Ability to learn and support new systems and applications, and the ability to provide technical training to end users. • Proficiency or comfort level working with material of a highly technical or scientific nature.

Education/Qualification Requirements: Undergraduate degree in Computer Science or any related field or 6+ years direct, relevant experience in IT (Computer Systems) validation to provide a comparable background

Experience Preferred: Minimum of 6+ years’ experience in IT (Computer Systems) validation in Computer Science or any related field or 9+ years direct, relevant experience Preferred

Qualifications:  Demonstrable ability to understand and comply with standards and best practices including Parenteral Drug Association (PDA), United States Pharmacopeia (USP), International Conference on Harmonization (ICH), and the International Society for Pharmaceutical Engineering (ISPE) methodology (e.g. GAMP 5). • Demonstrable advanced knowledge of domestic and international (e.g. FDA, Health Canada, MHRA, EMA) regulatory requirements and guidelines, including 21 CFR Part 11 and Annex 11. • Demonstrable working knowledge of corporate Quality Management Systems, current Good Manufacturing Practices (cGMP), and Good Clinical Practice (GCP). • Demonstrable advanced knowledge of data integrity best practices and regulations. • Demonstrable in-depth knowledge of software design, development, and maintenance and workflow development. • 6+ years of experience in leading the validation lifecycle for enterprise class IT systems (i.e. Laboratory Information, Enterprise Resource Planning, Electronic Document Management, Calibration Management, Environmental Management, etc.) with commercial off-the-shelf (COTS) systems. • 6+ years of experience in leading risk management planning and analysis for enterprise class IT systems (i.e. Laboratory Information, Enterprise Resource Planning, Electronic Document Management, Calibration Management, Environmental Management, etc.) with commercial off-the-shelf (COTS) systems. • 6+ years leading development of, Validation Plans, System Analysis/Assessments, Requirement Traceability Matrix, IT Change Management, IOQ/PQ Protocols/Reports and Validation Summary Reports.

Physical Requirements/Work Environment Location: Full Time Remote Setting: • Primarily Remote, Field Based Setting: When working remotely, the expectation for the travel time to our Pittsburgh, PA site should be typically less than 5-6 hours, with the maximum being 24 hours. This travel will support on-site situations such as occasional physical testing/configuration of systems/equipment, or occasional training. Travel: Less than 10%.

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