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Junior Validation Specialist in Camp Hill, PA , at Gannett Fleming

Date Posted: 9/10/2018

Job Snapshot

What You Will Do

Company Overview

At Gannett Fleming, we believe in improving the lives of the people we serve. We believe in innovation and social responsibility. We believe in the diversity of our team and the creative solutions they provide. We believe in embracing change and emerging technologies while maintaining an unmatched standard of quality. We believe in creating an environment where employees can thrive at home and at work. We believe in engaging our employees, building lasting relationships with our clients, and, in turn, making a difference in the world.

Excellence Delivered As Promised. It’s more than a slogan. It’s our standard. It’s the expectation we place upon ourselves as individuals and as a company. It represents our commitment to our valued clients, industry partners, and employees. It’s our earnest pledge to do what we say. It’s the core of who we are as a firm and the foundation upon which all of our relationships and projects are built.

What You Will Do

We are looking for a Junior Validation Specialist to support Life Sciences Group projects and our growing business in Gannett Fleming.  This position will be based out of one of the following offices: Lancaster (PA) or Camp Hill (PA).  It is an excellent time to come join our team.

Responsibilities:

  • 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 documents, traceability matrices, summary reports, and other supporting documentation for new and existing manufacturing equipment, processes, and products.
  • Develop Standard Operating Procedures (SOPs)and Work Instructions (WIs) for mechanical equipment, automated equipment/systems, 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) and Site Acceptance Testing (SAT) documentation for automated manufacturing and packaging equipment/systems, building automation systems, or other suppliers/vendors at the customers' or vendors' sites.
  • The primary work location for this position will be at Gannett Fleming’s client location in Allentown, PA.

Qualifications

Minimum Qualifications

  • A four-year degree in a technical, manufacturing, or quality related field preferred
  • Excellent verbal and written communication skills required
  • Knowledge of instrumentation and pharmaceutical processes and facilities equipment
  • Preference given to candidates possessing two or more years experience working in the pharmaceutical, biotech, or medical device industries
  • Experience with the authoring and execution of CQV documentation including validation documentation, technical protocols and/or technical reports preferred.
  • Strong preference given to candidates with packaging validation experience
  • Excellent attention to detail
  • Ability to handle multiple tasks, projects or assignments.
  • Experience working in an FDA-regulated environment and working knowledge of FDA (and of other regulatory bodies) Regulations/Guidance, and Good Manufacturing Practices
  • Demonstrated proficiency with Microsoft applications (Word, Excel, PowerPoint).
  • 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 as projects assignments require approximately 90% 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 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.

Preferred Qualifications

Life at Gannett Fleming

For more than 100 years, we’ve been a leader in global infrastructure solutions with a focus on planning, design, technology, and construction management services for a diverse array of markets and disciplines. Across more than 60 offices, 2,000+ highly qualified professionals are united in an unyielding commitment to deliver excellence to every client and every project, every day.

Gannett Fleming is an Equal Opportunity Affirmative Action Employer, including veterans and disability status. Gannett Fleming Inc. will not sponsor an employment visa (e.g., H-1B visa), including any visa renewal during employment, for any candidate for this position. No relocation assistance will be provided for this position. Local residents will be given preference.

NO AGENCIES PLEASE: Unsolicited resumes from third party agencies will not be accepted.

Location: Camp Hill, PA
Working Hours: 8 AM – 5 PM
Employment Status: Full-Time
Internal Requisition ID: 5127