Validation Consultant - Technical Safety Services

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?

• Develop Validation plans for small to medium size validation projects and write qualification/validation protocols, execute protocols and author reports.
• Supports the Validation Consulting team in evaluating all tests needed to qualify critical equipment, utilities, methods, and processes.
• Resolve protocol discrepancies and deviations
• Knowledge of risk-based validation approaches that meet current regulatory requirements, internal standards and industry practices
• Responsible for the peer review of validation reports and present the validation approach and study results to peers and managers.
• Present and defend validation studies during regulatory inspections and internal audits.
• Generate deviations, CAPAs, perform investigations and root cause analysis.
• Perform change control assessment
• Perform SOP revision, review and approval.
• Complete all internal and external training.

How will you get rewarded?

Compensation and Benefits

• Salary range of $100,000- $130,000 annually
  (Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with industry data.)
• Medical, vision, and dental insurance
• 401(k) plan with a company matching contribution
• Long-term disability, short-term disability, and life insurance
• Competitive Paid Time Off (PTO) and company paid holidays 

How will you get here?

Education and Experience

• Bachelor's degree in a technical degree with 3 plus years validation experience
• Familiarity with applicable US and worldwide regulatory requirements.
• Ability to read/interpret engineering drawings and design documents.
• Management of small to medium size projects
• Excellent technical writing and verbal communication skills
• Proficiency in Microsoft Office including Word, Excel, PowerPoint, Project and Vision
• Knowledge of Validation Lifecycle Approach

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.