Katalyst Healthcares and Life Sciences
Responsibilities:
- Designing validation plans.
- Conducting and documenting impact and risk assessments with a full understanding of
equipment/system/software operation and ability to assess direct, indirect, and no impact
systems and functions within complex processes. - Maintaining (and ensuring the team maintains) clear, detailed records of qualification and
validation, and change control activities for future compliance audits. - Designing and executing engineering studies for critical process parameter definition and
verification prior to validation. - uthoring, editing, and executing technical commissioning, qualification and validation
documentation for standard equipment/systems/ software, and processes as part of team as
directed by the project leader. - Running test scripts and documenting results.
- dherence with project schedule for all assigned activities.
- Maintaining clear, detailed records qualification and validation.
- Documenting impact and risk assessments as part of a team.
- Completing user interface testing, software verification, and complete alarm testing on
utomated systems. - Developing, reviewing, and executing testing documentation.
- Making recommendations for design or process modification based on test results when
executing test scripts. - General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ.
- Must be willing to work onsite in Kalamazoo, MI.
- Bachelor's Degree or equivalent required.
- bility to mentor and guide less experienced team members.
- bility to communicate effectively with clients.
- Proven ability to identify areas of business expansion and report to management team for
follow-up. - Obvious business maturity and interpersonal skills to be able to effectively communicate and
collaborate. - Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization.
- Demonstrated experience in leading CQV activities specific to Process Equipment.
- Proficiency using PC and Microsoft Office tools.
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
- bility to work as part of a team.
- Strong problem-solving and critical thinking skills.
- Excellent organizational and time management skills.
- Strong attention to detail.
- GMP and Good Documentation Practice.
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
- Basic skills with EXCEL and PowerPoint.
- Strong interpersonal skills and clear communication capabilities.
- Experience with and tolerance for high levels of challenge and change.
- Experience in GMP regulated environment.
- Proven attention to detail and organization in project work.
- Capable of working on assigned tasks without mentorship.