Validation Engineer II

Position Summary:

The Validation Engineer II is responsible for process knowledge of the validation section assigned to:

• Equipment
• Automated process control systems/Computerized systems
• Process & Cleaning
• Terminal sterilization
• Facilities & Utilities

The primary functions of the Validation Engineer II include the following:

• Possess process knowledge to write validation documents.
• Knowledge of validation theory and content of validation deliverables/activities
  • For Automated Systems: PLC, Controls, Robotics, Barcode Readers, Vision Systems, etc.
  • For Process and Cleaning: Technical Transfers of products
  • For Terminal Sterilization: Autoclaves, Sterilizers, Ovens
• Execution of validation documents to support company goals
• Development of validation procedures
• Supervises reporting technicians
• Acting as delegate for Sr. Validation Engineer in their absence

Essential Duties & Responsibilities:

• Develop Validation Plans, ensuring strategies are in alignment with validation policies, procedures and external regulatory requirements and guidance. As appropriate develop and maintain an annual plan to include periodic reviews, re-qualifications and continued process verifications to be completed during each calendar year. Reporting on progress as required.
• Write and execute validation documents (IQ, OQ, IOQ, PQ, PV, PR, CPV, etc.) compliant with plant policies and procedures. Proactively identifying risks/issues and completing risk assessments as necessary.
• Initiate and author validation assessments and validation gap analysis as required.
• Plan and lead revalidation of existing plant equipment (including sterilization equipment), facilities, utilities, processes, control systems, software, cleaning, etc.
• Review and approve validation documentation. (Mentoring Validation Technicians as applicable)
• Ensure validation packages contain all relevant information, rationales, references, and data to support the change or routine activities and that all reports and protocols are reviewed and approved as appropriate.
• Accountable for planning, tracking and reporting for assigned validation projects or activities.
• Own investigations in the event of failures or adverse trends; identify root cause, determine and complete corrective/preventative actions. Expected to seek subject matter experts (SME) and bring validation expertise, strong analytical and systematic problem-solving skills.
• Supervise and mentor validation technician(s) and supervise validation consultant(s) to provide project and technical direction, as needed.
• Work with supervision as needed and as provided by Sr. Validation Engineer or Manager
• Act as Change Control Owner for projects as required.
• Assess change controls; perform impact assessment based on knowledge of process and validation principles and policies.
• Provides technical training in validation to plant personnel
• Write or assist with the writing of Standard Operating Procedures and Validation Master Plans
• Review and provide feedback to plant and corporate policy writers on new and revised validation guidelines, specifications and policies
• Interact with Quality, Engineering, Manufacturing, Packaging, IT, and business area users as needed to understand processes, equipment functionality and use of automated control systems/computerized systems
• Communicate and manage timelines for validation projects to project manager or site management
• Additional travel may be required for Facility Acceptance Testing (FAT) of new equipment or technical transfer of new processes.
• Perform other related duties as assigned or required.

Knowledge, Skills & Qualifications:

• Must have basic knowledge and understanding of cGMPs, FDA and pharmaceutical industry guidelines. Knowledge in one of the following disciplines is required:
  • Validation
  • Manufacturing
  • Facilities/Utilities
  • Laboratory
  • Solution processes
  • Terminal sterilization
  • Automated controls systems/software
• Must have good organizational, presentation, meeting facilitation and technical writing skills.
• Working knowledge of statistics is preferred.
• Requires a high level of resourcefulness, an ability to get things done by removing obstacles, perceiving, and resolving problems, making difficult decisions with less than complete information provided, and finding ways to accomplish goals through innovative planning.
• Must maintain a thorough working knowledge of the ICU Medical Specification Systems. A high level of attention to details and the ability to proofread and audit validation documents is required.
• Must be able to work weekends and holidays as required to meet deadlines.

Education and Experience:

• Bachelor’s Degree required: Engineering or Science (Engineering Preferred)
• Candidates with other technical bachelor’s degrees will be considered if they have two (2) or more years of direct validation experience.
• A minimum of two (2) years’ experience is required. Direct validation experience preferred.
• Experience interacting with regulatory and third-party representatives preferred.
• Prior supervisory experience is desirable but not required.

Minimum Qualifications:

• Must be at least 18 years of age.

Travel Requirements:

• Typically requires travel less than 5% of the time.

Physical Requirements and Work Environment:

• Time split between office and manufacturing environment. Some physical demands when working on the manufacturing floor executing validation runs.
• Occasional lifting. Must be able to lift up to 25 lbs unassisted.