Junior Validation Specialist

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GFT is seeking a Junior Validation Specialist to join our Building and Places Group! This position can be based in Eastern Pennsylvania or Central New Jersey.

• This position requires a minimum of 3 days per week in-office or on-location, except during protocol execution periods which require 100% on-location effort
• GFT office assignment location is negotiable
• Client and OEM vendor sites vary per project, and the majority of work is expected to take place in eastern Pennsylvania and central New Jersey
• This position requires occasional travel outside of the primary region: domestically and internationally (~15%)

What you’ll be challenged to do:
This is an excellent career opportunity for an experienced, motivated Validation Specialist who thrives in a collaborative team environment. The role highlights a customer-focused mindset and a passion for delivering exceptional quality and results on every  this capacity, the successful candidate will be responsible for the following:

• Author and execute CQV (Commissioning, Qualification, Validation) test case scripts / protocols for mechanical equipment, automated equipment/systems facilities and utilities with minimal supervision.
• Author validation plans, risk assessments, requirement and specification documents, traceability matrices, summary reports, and other supporting documentation for new and existing manufacturing equipment, processes, and products
• Develop Standard Operating Procedures (SOPs) for mechanical equipment, automated equipment/systems, manufacturing processes, and facilities and utilities with minimal supervision
• Specialized and demonstrated knowledge in the area of one or more of the following pharmaceutical manufacturing processes is required – computer system validation, automated equipment/systems qualification and validation, facilities and utilities commissioning and qualification, or primary and secondary packaging systems (strongly preferred)
• Develop, oversee, and/or execute Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and Installation/Operational Qualification (IOQ) protocols for automated manufacturing and packaging equipment/systems, building automation systems, or other suppliers/vendors at the customers’ or vendors’ sites

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What you will bring to our firm:

• A four-year degree in a technical, manufacturing, or quality related field preferred
• Experience working in the pharmaceutical, biotech, or medical device industries is a plus
• Knowledge of instrumentation and pharmaceutical processes and facilities equipment is a put
• Strong preference given to candidates with packaging validation experience
• Ability to handle multiple tasks, projects, or assignments simultaneously
• Demonstrated proficiency with Microsoft applications (Word, Excel, PowerPoint).
• Excellent verbal and written communication skills, as well as attention to detail, required
• Must be able to work independently and to coordinate with team members in other offices
• You will have the ability to travel to client locations in Eastern PA and Central NJ as projects assignments require; approximately 50% of your time
• Ability to travel domestically for one to two weeks per trip for equipment FAT; approximately 10% of your time
• Ability to travel internationally for one to two weeks per trip for equipment FAT; approximately 5% of your time
• Ability to work flexible and overtime hours including evenings and weekends to meet business needs (occasionally)
• Ability to work with multiple teams and clients, at multiple locations, and occasionally from a home office

Compensation: The salary range for this role $60,000 -$80,000. Salary is dependent upon experience and geographic location.

Featured Benefits:

• Hybrid (in-person and remote) work environment.

• Comprehensive benefits package including wellness programs, parental leave, and pet insurance, in addition to medical, dental, vision, disability, and life insurance.

• Tax-deferred 401(k) savings plan.

• Competitive paid-time-off (PTO) accrual.

• Tuition reimbursement for continued education.

• Commitment to professional development, access to internal and external training programs, and support of active participation in professional organizations

• Incent…