Onsite Validation Engineer – Pharma IQ/OQ/PQ Lead

Fresenius Kabi; Melrose Park (FL); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation, holidays and personal/s

Employee assistance program

Medical, dental and vision coverage

Wellness program

Job summary

Fresenius Kabi in Florida seeks an experienced Validation professional to lead IQ/OQ/PQ activities for equipment, facilities and utilities in a pharmaceutical manufacturing setting. The role requires planning, documentation and collaboration with multiple teams to ensure compliance and progress against milestones.

You will develop validation plans, ensure current cGMP practices, and contribute to energy management improvements while adhering to regulatory requirements.

Qualifications

• Bachelor degree in Engineering or a Scientific Field required.
• Minimum of 3 years relevant experience in a cGMP facility; pharmaceutical industry experience preferred.
• Proficient in generating reports, technical writing/reviewing skills and other technical documents required.
• Knowledge and understanding of cGMPs, industry guidance and aseptic techniques needed.
• PC literate with Microsoft Office proficiency.

Responsibilities

• Independently plan, perform and document validation activities (IQ, OQ, PQ) for equipment, facilities and utilities in a pharmaceutical manufacturing environment.
• Create validation schedules, coordinate execution with contractors, production operators, manufacturing engineers and QA personnel.
• Track and communicate progress of work against milestones.
• Compose validation plans, protocols, traceability matrices, risk assessments and final report summaries.
• Develops/improves validation programs to stay current with cGMPs.
• Represents Validation in teams to specify, install, validate, troubleshoot and maintain systems, equipment and processes.
• Conduct deviation investigations to identify root causes and define corrective/preventive actions.
• Maintain and improve ISO 50001 energy management system; identify energy savings opportunities.

Skills

Technical writing

cGMP knowledge

Microsoft Office

Education

Bachelor degree in Engineering or a Scientific Field

Tools

Report generation

Job description

Fresenius Kabi in Florida seeks an experienced Validation professional to lead IQ/OQ/PQ activities for equipment, facilities and utilities in a pharmaceutical manufacturing setting. The role requires planning, documentation and collaboration with multiple teams to ensure compliance and progress against milestones.

You will develop validation plans, ensure current cGMP practices, and contribute to energy management improvements while adhering to regulatory requirements.