Validation Engineer (Contract) 24566

Job Description

The Validation Engineer works with a high degree of independence and is adept at troubleshooting problems to create and execute improved internal procedures, and to ensure compliance with applicable regulatory requirements. Senior Validation Engineer work intensively with and execute actions directed by Validation Manager. The Validation Engineering Senior Specialist completes work in a resourceful, self-sufficient manner and can design alternative approaches to achieve desired outcomes. The Validation Engineering Senior Specialist is responsible for specific pieces of moderately complex projects and may work on multiple projects.

 

 

Key Duties and Responsibilities:

• Provide cleaning validation expertise with a hands-on role managing cycle development, coverage studies, cleaning validation, clean and dirty hold studies for OSD equipment to be cleaned utilizing two new automated parts washers.
• Ability to collaborate across functional lines to plan, schedule and execute all activities related to successful completion of all elements of the VMC Cleaning Validation Master Plan.
• Develop and implement/update cleaning validation program execution strategy, generate and acquire approval for plans, protocols and final reports.
• Ensure that cycles and recipes are optimized for the new parts washers for OSD equipment
• Provide day-to-day support of the Validation function encompassing equipment validation, automated system validation, instrument qualification, operational controls to maintain the validated state of systems, and regulatory compliance
• Support Manufacturing equipment / system implementations as validation SME to ensure that appropriate regulations (e.g. 21CFR Part 11 and cGMP) are addressed during validation in a phase appropriate and risk balanced manner
• Provide Validation support to prepare, assist, and participate during engineering and design of systems, assist with specification development, and facilitate design reviews.
• Work closely with colleagues within the Engineering team, Validation, GMP Operations and QA to ensure COP recipes, batch record instruction and standard work practices meet the needs of timelines of cleaning verification/validation.
• May develop validation deliverables as needed such as qualification protocols, gap assessments, risk/impact assessments, user requirements, requirements traceability, validation plans, validation summary reports and change controls
• Provide training to project teams and vendors on Vertex practices, regulatory requirements, and industry trends as it pertains to validation
• Support and provide input into system administration and maintenance procedures to ensure adequate controls for maintaining the validated state
• Interface with Quality Document Control for managing and archiving validation artifacts for manufacturing equipment / systems
• Independently solve validation related problems and implements corrective actions as needed
• Performs other duties as assigned by the Validations Manager and work intensively with and execute actions directed by Senior Validation Engineers

 

Knowledge and Skills:

• Understanding of cleaning validation in Non-Sterile Oral Solid Dose (OSD) Manufacturing Facility
• Working knowledge of current CQV methods, including ISPE, ICH, and ASTM E2500 methodology
• Preferred experience in validation of Temperature Controlled Units
• Proficient using Kaye Validator and/or other latest type of Data Loggers
• Demonstrates ability to solve complex problems to attain crucial Project goals
• Experience with working and/or writing technical documents in the pharmaceutical industry
• Clearly demonstrates an extensive understanding of quality and regulatory compliance as well as the application of these concepts
• Thorough knowledge of and high competence in core quality systems such as change control, deviations, and document control
• Must be well organized and willing to work as part of a team
• Strong communication skills both oral and written
• Demonstrable collaboration, facilitation, and negotiation skill effectively

 

Education and Experience:

• Bachelor’s Degree in Engineering Discipline or related field
• 3+ years of experience working in the GMP environment

Pay Range

$50-$65/hr depending on experience

Requisition Disclaimer

This job posting is for a temporary role with a third-party agency partner on assignment at Vertex Pharmaceuticals (“Vertex”). The individual selected for this role will be offered the role as an employee of a third- party agency partner; compensation, medical benefits, fringe benefits and other ter