Primary Responsibilities:
Routinely interact with engineers, project managers, business unit owners as well as senior personnel responsible for Non-product software (NPSW) and infrastructure as they relate to St. Louis operations. Responsible as a site software QA Validation Engineer to represent St. Louis when globally deployed computer systems are implemented.
Primary Responsibilities:
- Participate in projects as assigned with limited supervision.
- Attend Non-Product Software CRB/IMP meetings and advise cross functional team members for planning validation, change management and decommissioning of NPSW systems
- Participate in CRB meetings as a non-product software QA representative. Support CAPA, investigations, NCs, Waivers as QA function. Revise and update validation SOPs and Site Validation Master Plan as required.
- Lead NPSW risk assessment efforts as needed.
- Act as a subject matter expert on part 11 requirements and computer system validation (CSV).
- Review and approve validation documentation ensuring conformance to site and global procedures as well as ISO, QSR, GXP, and/or GAMP regulations.
- Participate in NPSW change control process for system changes, re-validation, and re-qualification initiatives.
- Support supplier and internal audit initiatives related to NPSW as needed.
- Represent the needs of the site for globally deployed computer systems.
- Reasonable, reliable attendance and punctuality is an essential job function required for this position.
- Ability to interface across multiple disciplines of the organization
- Support FDA and MDSAP Audits
- Participate in QA oversight activities for production, IND, MES, calibration, maintenance, and facilities.
- May supervise and/or train associates and/or contractors as needed.
Experience, Knowledge, Skills, and Abilities:
- Requires a Bachelor’s Degree in Life Science, Computer Science, Engineering, or other equivalent discipline and 5 years minimal experience with Computerized System validation lifecycle.
- Software Quality Assurance experience highly desired.
- Medical Device or other FDA regulated industry experience required.
- Must possess effective written and verbal communication skills. Must be able to communicate effectively across all levels of management including executive level.
- Requires strong computer skills including Microsoft Office Package (Excel, Word, etc.).
- Must have a expert knowledge of the interpretation and application of relevant Domestic and International Regulations and Industry Standards (MDSAP, 21CFR820, ISO 13485, QSR, etc.).
- Competence in Medical Device Development Processes and/or Computer System Lifecycle validation compliance demonstrated by relevant industry experience.
- Competence in the interpretation of GXP, QSR regulations to provide guidance as appropriate for computerized systems and automated business processes to achieve compliance.
- Experience with determining priorities and resource allocation from a project site and corporation perspective.
- Proficient in Microsoft Suite
- Experience utilizing Seapine TestTrack, Sparta Trackwise, MSProject, Mindjet MindManager, Rockwell Automation Factory Talk Pharma Suite 4.0, Perforce Software management, PTC Windchill are a plus.
- Strong interpersonal and teamwork skills are required as this role will work globally as needed.
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