Validation Engineer

GSK; King of Prussia (PA); On-site; USD 70,000 - 90,000; Full time

Job summary

A global healthcare company is seeking a Validation Engineer in King of Prussia, PA. In this role, you will handle equipment and facility validation projects, design validation studies, and execute protocols. Ideal candidates hold an associate's or bachelor’s degree with experience in biotech or pharma, possess strong technical writing skills, and are familiar with cGMPs. This is an excellent opportunity to advance your career in a dynamic environment.

Qualifications

• Associates degree with 2+ years with biotech or pharma experience.
• Familiarity with Lock out tag out.

Responsibilities

• Design validation studies and write protocols.
• Execute validation studies safely and compliantly.
• Analyze test data and lead investigations on failures.

Skills

Familiar with cGMPs

Strong interpersonal skills

Technical writing skills

Validations engineering experience

Strong verbal communication skills

Education

Associates degree with 2+ years experience or BS/BA degree with 1+ year experience

Tools

Kneat

Kaye Software

Job description

We make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics.

We continue to modernize, so we can launch even more new products at speed whilst turbo-charging delivery across our entire portfolio through our relentless focus on quality, safety, and service. The way we work will change. For some, the shift in technology and products will be revolutionary. Our R&D pipeline demands a new kind of supply chain, and we need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of automation and robotics so we can work smarter together.

As a Validation Engineer, you will be responsible for equipment/facility validation projects in a hands-on role including writing validation protocols, scheduling and executing testing, gathering and analyzing data, and writing validation summary reports. This person will participate as a supporting member representing validation on project teams. Validation Engineers will lead specific validation projects.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include:

• Design required validation studies and write protocols for the facility and equipment.
• Coordinate resources required to complete validation studies in a timely manner.
• Execute validation studies per required schedules in a safe, compliant manner (e.g. LOTO).
• Analyze test data and report questions/issues. Lead and document investigations of failed validation test results.
• Complete validation protocols and validation summary reports with necessary approvals.
• Support the review of new systems and modifications to existing systems to ensure designs comply with cGMPs and are able to be validated and maintained in a validated state.
• Maintain validation equipment and supplies to enable validation to be completed per schedule requirements.
• Support the development of required validation procedures and practices with respect to the facility.
• Identify issues and/or improvements to validation procedures, practices, and policies related to validation, equipment and processes.

Why you?

Basic Qualifications:

• Associates degree with 2 + years with biotech or pharma experience
• OR BS/BA degree with 1+ year of experience with biotech or pharma

Preferred Qualifications:

• Familiar with cGMPs.
• Strong interpersonal and organizational skills.
• Technical understanding of the industry and validation practices related to the pharmaceutical industry is preferred.
• Strong verbal and written communication skills.
• Must be able to interact well with peers and senior personnel in multidisciplinary teams involving scientific, engineering, and operational disciplines.
• Able to take directions and effective at implementing decisions.
• Must have strong technical writing skills.
• 1+ years of process engineering or validation engineering experience with biotech or pharma
• Understanding how to read or process P&ID
• Working with Kneat
• SIP and CIP validation experience
• Familiarity with Lock out tag out
• Prior experience with Kaye Software in temperature mapping

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.