Validation Process Engineer

Validation Process Engineer

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Location : Kansas City, MO

Time Type : Full time

Posted On : Posted 3 Days Ago

Time Left to Apply : End Date : November 14, 2024 (27 days left to apply)

Job Requisition ID : 0083660

Position Summary

Catalent Pharma Solutions in Kansas City, MO is hiring a Validation Process Engineer. The Validation Process Engineer supports identification and onboarding of equipment for both clinical and commercial operations and optimizes processes / equipment using lean six sigma (or equivalent), project management, and management of change tools.

The Validation Process Engineer supports authoring protocols / reports and managing the execution of equipment, freezer / cooler, utilities, facilities, cleaning, and process validation.

This position reports to the Engineering Manager.

This is a full-time role position : Monday Friday, Days. 1st Shift 8 : 30am-5 : 00pm.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.

The Role

• Develop User Requirement Specifications for new equipment, identify equipment vendors, procure equipment, oversee build, and ensure that equipment meets functional requirements.
• Submit capital requests and manage project budget / timelines to completion.
• Preparation / Execution / Review of Validation Plans (VP), System Impact Assessments (SIA), Requirements Specifications (RS), Design Specifications (DS), Functional Requirements Specification (FRS), Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), and Validation Summary Report (VSR) for equipment and critical systems and utilities, Process Performance Qualification (PPQ) for the product manufacturing process and Release Authorization to release validated items into use.
• Design and execute Performance Verification (PV) / Engineering Studies (ES). Support Factory Acceptance Tests (FAT), equipment installation, and Site Acceptance Tests (SAT) for equipment as needed.
• Author Procedures and Work Instructions for equipment operation. Coordinate and train operations and maintenance personnel.
• Identify and capture equipment key performance indicators (KPI) from equipment and qualified equipment parameters and settings while mitigating impact on change-over cycle times.
• Perform risk assessments for safety hazards on all equipment and work with EH&S personnel to design appropriate mitigation of hazards.
• Understand process flow, help identify bottlenecks, support GEMBA walks, and efficiency improvements and work with appropriate parties to provide corrective and preventive actions based on sound engineering analysis.
• Provide technical support for deviations and CAPAs and audits.
• All other duties as assigned.

The Candidate

• Required a Bachelor’s Degree preferably in Engineering or Life Sciences.
• 2+ years of experience with GMP equipment onboarding / validation / modification highly preferred.
• Possess good communication and problem-solving skills highly desired.
• Working knowledge of Microsoft Outlook, Word, Excel, Internet Explorer required.
• Ability to work well with people of diverse cultures preferred.
• Individual may be required to sit, stand, walk regularly and occasionally lift up to 50 pounds.

Why you should join Catalent :

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• 152 hours of PTO + 8 paid holidays.
• Several Employee Resource Groups focusing on D&I.
• Dynamic, fast-paced work environment.
• Positive working environment focusing on continually improving processes to remain innovative.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive salary.
• Community engagement and green initiatives.
• Generous 401K match and Paid Time Off accrual.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement.
• WellHub program to promote overall physical wellness.
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to [email protected].

Notice to Agency and Search Firm Representatives : Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and / or search firms for this job posting.

Important Security Notice to U.S. Job Seekers : Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process.

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