Katalyst Healthcares and Life Sciences
Job Location : Milwaukee,WI, USA
Posted on : 2025-08-05T07:50:00Z
Job Description :
Responsibilities:
- Lead computer system validation projects related to authoring and executing specifications and validation documentation for enterprise computer systems.
- uthor validation protocols ensuring that the technology solutions being implemented are compliant with all relevant regulations (i.e., 21 CFR Part 11, Annex 11, GxP, local and corporate policies).
- Review and (remote) execute Computer System Validation protocols to ensure compliance and adherence with corporate guidelines procedures, cGMP and ISPE GAMP 5 guidelines and regulations.
- Understands how aspects of data integrity, security, access, and safety are addressed through the various protocols.
- Write risks assessments according to GMP and 21 CFR Part 11 compliance guidelines. Prepare validation summary reports for executed protocols.
- ssist, investigate and resolve Deviations, CAPA investigations and other potential issues.
- Develops validation deliverables such as Validation Plans, Requirements Specifications, Validation Protocols, Traceability Matrices, Summary Reports, Change Controls.
- Validates software for Laboratory and Manufacturing instruments.
- vailable to attend meetings as necessary.
- Periodic Review activities.
- bility to manage three to four active projects.
- Waters/Empower.
- Various Laboratory Instrument Software.
- Various Manufacturing Instruments Software.
- Other Enterprise Applications as Required.
Requirements:
- BS/BA required in a related field.
- 5+ years minimum required relevant experience.
- Minimum of +7 years in the FDA regulated industry.
- 5+ years Document Authoring experience, SOP revisioning experience and re-executing protocols.
- Working knowledge of GMP, 21 CFR Part 11 and Annex 11.
- bility to work on multiple concurrent project initiatives.
- Experience with Laboratory and Manufacturing Instrument Software Validation.
- Experience in validating Enterprise systems (both on premise and cloud). Examples are SAP, Empower, Labware, Veeva.
- Worked with different validation models from V-Model to CSA.
- bility to apply Agile and Waterfall methodology.
- Excellent written and verbal communication skills.
- Highly motivated, enthusiastic to learn and share ideas and solutions effectively with management and colleagues.
- Strong collaboration with colleagues at all levels.
- Strong customer service and teamwork oriented.
- bility to take initiative, to be assertive, to lead by example and to build high-quality relationships.
- Highly flexible, adapting to changes in priorities, requirements and processes is required.
- French language proficiency is a plus.