Validation Specialist

Validation Specialist

Gill's Process Control Inc. - Rocky Mount, NC

At Gill's 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 Gill's, 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 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.

A 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 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 validation specialist to generate test plans and scripts and then assist with test execution and data collection. The 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.  

DUTIES & RESPONSIBILITIES

• Writing validation plans, test plans, protocols (IQ/OQ/PQ), test scripts, and reports
• Execute validation strategies and acceptance criteria based on established site, industry and regulatory standards
• Development or revision of requirement and design specifications
• Establishing traceability from specifications to test scripts
• Processing change control requests documents
• In-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents
• Experience with Automated Systems (PLC, HMI)
• Experience with pharmaceutical manufacturing systems and equipment such as: Sterilizers, Isolator technology, Fillers, HVAC systems, and Utility systems
• Investigating unexpected events and classifying incidents and documenting their impact
• Performing risk assessments for requested changes to validated systems
• Summarize validation results in well organized, accurate and complete manor
• Gather information needed to design the protocols by interacting with clients
• Route validation documents for initial and final approval, this will require the ability to walk and carry binders of documents at times (client dependent)
• Plan, schedule, execute protocols and test scripts and communicate project status. 
• Develop a working knowledge of the project budget, and works to stay within allotted budget for all project aspects
• Provides weekly update to the client or manager of project statuses.
• Schedule and lead project meetings using excellent communication skills
• Review client Standard Operating Procedures (SOP), cGMP and FDA regulations

SECONDARY RESPONSIBILITIES (including but not limited to):

• Communicate with clients to develop relationships
• Network with clients and industry associates to develop job opportunities
• Complete timesheets, to be submitted daily
• Meet with manager to communicate project status

REQUIREMENTS

• 4 – year college degree preferred
• Proficient In Microsoft Word and Excel
• 3 or more years or more experience in pharmaceutical manufacturing environment
• In-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents
• Experience with Automated Systems (PLC, HMI)
• Experience with pharmaceutical manufacturing systems and equipment such as: Sterilizers, Isolator technology, Fillers, HVAC systems, and Utility systems
• Must be proficient in the ability to write validation protocols and reports
• Skilled in technical writing and document control
• Must have a project management mentality and excellent communication skills
• Must have strong organizational skills to maintain data and documentation
• Ability to work independently without direction but also able to work within a team
• Proficient with MS Word and Excel
• Must have valid driver’s license and reliable transportation
• Must be willing to commute within central to eastern NC – this is not a remote position

BUSINESS COMPETENCIES

• Solid decision making skills
• Solid problem solving skills
• Self-management
• Time management
• Clear communication to all levels of the team and the client
• Capable of managing, communicating and leading change as it happens

ESSENTIAL FUNCTIONS OF THE JOB

• Must be able to work in and maintain composure in a fast-paced, loud environment for long periods of time
• Must be able to speak, read, write and understand the primary language(s) used in the workplace
• Must possess basic math skills (add, subtract, multiply, divide, calculate percentages)
• Must be able to work on a computer for long periods of time
• Must be able to work in a standing position for long periods of time (up to 9 hours)
• Must be able to bend, stoop, squat and lift on a regular and continuing basis
• Must wear company provided safety equipment (ex. Safety vest, hard hat, goggles, safety shoes) when required
• Meticulously and strictly adhere to all safety policies – lifting, ladder use, carrying, ergonomics
• Must maintain a neat, clean and well-groomed appearance per Gill's standards
• Must be able to work on holidays and/or weekends
• Must be able to meet attendance requirement

MEASURES OF SUCCESS

• Adherence to Gill's core values
• Client satisfaction
• Meeting project/goal deadlines
• Meeting or beating project budget that is your responsibility