At GPCi we value our team first. Our teammates are the key ingredient that makes us unique. They embody core values that strengthen our culture and guide our overall success. Our specialists must be knowledgeable and willing to go the extra mile in the service of the client, your success is our success. We are looking for career minded, team players who want to grow along with us and create an excellent client and teammate experience!

At GPCi, we see every day as a chance to create a positive impact. We lead through our values centered on service, integrity, community and family. From our support of Local Charities, to our Ministry Action Team, our values keep us dedicated to using our resources for good: good for our team, clients, industry and human kind.

SUMMARY OF POSITION

The Automated Systems Validation Specialist position involves technical writing, project planning, client interaction and project management. The position requires a working knowledge of FDA pharmaceutical manufacturing regulations and current Good Manufacturing Procedures (cGMP) as well as excellent technical writing skills, proficiency in word processing and spreadsheet programs.

An Automated Systems Validation Specialist is assigned a project and is expected to work with the client to establish a validation approach, generate the required life cycle documents, including URS, FRS and SDS documentation, to meet cGMP requirements, to be in compliance with FDA guidelines and client operating procedures. The documents often include installation and operational qualification protocols. These protocols may require the Automated Systems Validation Specialist to generate test plans and scripts and then assist with test execution and data collection. The Automated Systems Validation Specialist will then generate validation summary reports for the protocols and change control documents. This position often requires the development of requirement and design specifications for various pieces of pharmaceutical manufacturing equipment. Knowledge of industrial controllers and operator interfaces is required to generate these specifications.

The Automated Systems Validation Specialist is responsible for providing technical support to the manufacturing and logistics buildings at the client site for protocol and testing script development associated with software review, testing, trouble-shooting, and assessing/testing modifications and improvements to automated systems and data management/storage systems.

What you'll do:

• Tests automated systems, recipes, control systems, and Human Machine Interface (HMIs).
• Perform testing in a simulated environment (development/pre-production) or production environment.
• Basic understanding of converting sequences of operations into detailed design specifications (DDS).
• Advanced understanding of Good Automated Manufacturing Practice (GAMP) and GAMP categories.
• Understanding of validation principles, including familiarity with automated system principles such as I/O functionality, alarm activation and response, process sequential control, audit trail and data integrity, etc.
• Familiarity with one or more of the following:
  • PLC systems, particularly Siemens and Rockwell Automation
  • Distributed control systems, particularly Emerson DeltaV
  • Building management systems, particularly Siemens and or Metasys
  • IT infrastructure
• Proficiency in investigation, problem solving, risk assessment and mitigation.
• Subject matter expert for validation planning.
• Leads validation assessments for proposed changes.
• Advanced understanding of validation/documentation hierarchy.

What you’ll bring:

• B.S. in Engineering, Computer Science, or other technical field
• Proficient In Microsoft Word and Excel
• Excellent technical writing skills
• Minimum of 6 months experience in Automated Systems
• Minimum of 6 months of Pharmaceutical/Bioscience experience

What you’ll get:

We believe in a team mentality, and that happy teammates are successful ones. That’s why we give our team the tools and the autonomy to learn, grow, have fun and be themselves.

We invest in our team, with internal programs, training, and initiatives to develop your skills and help you reach your goals. We promote from within. We provide you with the tools, skills, and resources to develop, both professionally and personally. You choose where you want to go; we help you get there.

We strive to make the world a better place and empower others to do the same. We are missiondriven and we leverage the power of our team to make a positive impact in the communities in which we live and work.

We celebrate successes and reward our teammates for the hard work they do every day. We offer benefits to keep you healthy and happy, such as:

• Paid Time Off (PTO)
• Vacation
• Health Care
• Retirement IRA plan
• Short term disability