Senior Validation Engineer - Katalyst Healthcares & Life Sciences

• 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

• Authoring, 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 leade

• Running test scripts and documenting results

• Adherence 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 automated 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

Requirements:

• Bachelor's Degree or equivalent required

• Ability to mentor and guide less experienced team members

• Ability 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

• 4 - 6 years of demonstrated role relevant experience

• 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

• Ability 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