Validation Specialist

GFT is seeking a Validation Specialist  to join our Building and Places Group  This position can be based in Eastern Pennsylvannia 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 project. 

In 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.
• 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.
• 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

What you will bring to our firm: 

• A four-year degree in a technical, manufacturing, or quality related field preferred
• 5+ years experience with the authoring and execution of CQV documentation including validation documentation, technical protocols and/or technical reports preferred
• 5+ years experience working in an FDA-regulated environment and working knowledge of FDA (and of other regulatory bodies) Regulations/Guidance, and Good Manufacturing Practices
• Knowledge of instrumentation and pharmaceutical processes and facilities equipment
• 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 towork 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
$95,000 -$130,000. 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
• Incentive compensation for eligible positions.  
Physical Capabilities Required to Perform Job: Light Lift/Carry – less than 40 pounds, Read PC screens, read fine/normal print size, employee is occasionally required to sit, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, wear job-site required personal protective equipment (PPE) such as lab coats, coveralls, safety shoes, shoe covers, safety glasses, hard hats
Mental Capabilities Required to Perform Job: Communicate utilizing a telephone, Compute/analyze/interpret data, Conduct/maintain interpersonal communication, Establish and meet deadlines, Organize/prioritize work, Understand complex problems/explore alternatives, Ability to work in a fast-paced work environment, Ability to work independently and as a team member

At GFT, a privately held AEC firm, we innovate where transportation, water, power, and buildings converge. We call this the Infrastructure of Life. We measure our success by the strength of our relationships – that's why we're the employer of choice for 5,000+ of the industry's brightest engineers, planners, architects, inspectors, designers, and more.

Our clients choose us for our expertise and prefer us for our nimble approach, creativity, and personal touch. Backed by over a century's experience, together we're building a lasting legacy for future generations: stronger communities, a healthier planet, and better lives.GFT: Ingenuity That Shapes Lives is an Equal Opportunity Employer. All qualified candidates will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veterans' status or other characteristics protected by law.

Unsolicited resumes from third party agencies will be considered the property GFT.

Location: Central NJ or Eastern PACore Business Hours: 8:00 AM – 5:00 PMEmployment Status: Full-Time Salary Range:$95,000 -$130,000Salary dependent upon experience and geographic location

GFT does require the successful completion of a criminal background check for all advertised positions.

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