Who are we?

Technical Safety Services (TSS) is a leading laboratory service provider with locations across the United States. Our customers include leading life sciences and healthcare companies and renowned research institutions. We are rapidly growing and looking for additional passionate and talented employees to join our team and partner with TSS’ customers who are doing dramatic work focused on improving the human condition.

TSS ensures the equipment our customers use to keep their employees and products safe is in full working order. We are the leading provider in the country of testing and certification services for cleanrooms, fume hoods, biological safety cabinets, and other controlled environment equipment. Working at our customers facilities, TSS employees are key enablers – helping ensure safety, accuracy, and compliance in some of the leading laboratories in the United States.

How will you make an impact?

The Validation Engineer is part of the Validation Operations team TSS. The Validation Engineer will review and/or execute primary validation activities for equipment, utilities, computer systems and manufacturing processes at TSS customer locations. Support for all projects will be provided by senior management of TSS. The most critical metric for a validation engineer is customer satisfaction.

 What will you do?

• Analyzes validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
• Develops validation master plans, commissioning documents, validation protocols (IQ, OQ, PQ), process flow diagrams, test cases, or standard operating procedures. Executes protocols at various client locations.
• Identifies deviations from established equipment, product or process standards and provide recommendations for resolving deviations.
• Prepares, maintains, or reviews validation and compliance documentation, such as engineering change notices, schematics, or protocols.
• Studies product characteristics or customer requirements and confer with management to determine validation objectives and standards.
• Assists in training equipment operators or other staff on validation protocols and standard operating procedures.
• Conducts validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols or external standards.
• Coordinates the implementation or scheduling of validation testing with affected departments and personnel.
• Designs validation study features, such as sampling, testing, or analytical methodologies.
• Prepares validation or performance qualification protocols for new or modified manufacturing processes, systems, or equipment for pharmaceutical, electronics, or other types of production.
• Adheres to all customer/company and GMP procedures, along with safety regulations within the workplace.

How will you get here?

Education and Experience

• Requires a Bachelor’s degree in a Technical Field; Engineering or Science discipline preferred.
• Experience working in life science industry required.
• Requires 5 plus years in the validation and/or quality arena.
• Requires a minimum of 4 years customer service experience in the pharma/bio, medical device or healthcare field.
• Minimum of 2 years experience working in GMP environments.
• A combination of education, training and related experience may meet requirements

Knowledge, Skills and Abilities

• Strong interpersonal skills to drive collaboration, commitment and productivity when working with cross-functional teams and customers.
• Excellent verbal and written communication skills, including the use of open and constructive feedback.
• Experience in interpreting graphs, charts, engineering diagrams (P&ID), blueprints, specifications, equipment manuals and guides and other instructions to solve problems.
• Experience writing test plans, project plans, procedures, and project schedules.
• Experience writing User Requirements, Functional Requirements, Design Specifications, commissioning documents, FAT’s, SAT’s, IQ’s, OQ’s, PQ’s.
• Experience executing FAT’s, SAT’s, receipt verification, IQ, OQ, PQ.
• Experience using scientific rules and methods to solve problem.
• Knowledge of cGMP Equipment, Process and Product Validation requirements and techniques.

While performing the duties of this job, the employee must regularly lift and/or move up to 50 pounds and occasionally lift and/or move more than 100 pounds. The employee is regularly required to sit and talk or hear. The employee is frequently required to reach with hands and arms. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

TSS is a passionate equal opportunity employer and celebrates diversity. Interested in a role but not sure it’s the right fit for you? Call us and let’s talk.