Validation Engineer

About the role

We are looking to hire a Validation Engineer immediately. The Validation Engineer is responsible for managing, inspecting, testing, and modifying the instrumentation, equipment, mechanics, and procedures used to manufacture products in accordance with all company Standard Operating Procedures and manufacturing instructions, and to ensure all systems and processes are running correctly and efficiently to produce high quality products.

Responsibilities

• Performs validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensures systems remain in a qualified, operational state of compliance associated with cGMP manufacturing work environment.
• Generates, reviews, and executes the master validation plan, validation protocols (IQ, OQ, PQ) on equipment, utilities, and computerized systems ensuring compliance with cGMP.
• Prepares all implementation of change request using the “Change Management Request” (CMR) process initiated internally or from customers by collecting all relevant documentation, initiating a change request, route for approvals, implement the plan and close the request accordingly.
• Apply concepts of Continuous Monitoring through Statistical Process Control (SPC) to ensure the processes that have been transferred into production are monitored and controlled appropriately to maintain the equipment in a validated state.
• Prepares protocols, reports, and other necessary documentation for validation to determine whether systems and processes meet required criteria and specifications; identifies root causes of production or equipment problems.
• Evaluates current equipment and procedures used in production to certify operations are within regulations.
• Investigates and conducts troubleshooting and root cause analysis of validation related incidents and deviations.
• Resolve CAPA's, non-conformances, protocol incidents, and change controls related to validation protocols.
• Establish validation standards, develop testing protocols, prepare equipment, document test results and analyze results to ultimately determine if a new process or new equipment meets policies and standards.
• Communicate with outside vendors to identify new equipment or perform equipment troubleshooting if problems arise.
• Maintains validation documentation through the validation lifecycle including protocols, deviations and corrective actions.
• Perform risk assessments, failure mode effects analysis (FMEA), and statistical data analysis to support validation activities.
• Represent the engineering process during customer, certification and regulatory audits (internal and external).
• Absorb and participate in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines; stay current with regulatory trends and validation best practices to enhance validation strategies.
• Write new and revise current Standard Operating Procedures (SOPs) and Work Instructions as needed.

Qualifications

• BS in Engineering (Chemical preferred), life sciences or related field.
• 3+ years of validation work experience in a pharmaceutical and/or medical device industry.
• Certified Quality Engineer/Validation professional a plus.
• Experience with validation of cleaning, software, automated systems, packaging and laboratory equipment desired.
• Experience authoring and executing Validation protocols such as Installation and equipment operation.
• Strong understanding of FDA regulations, cGMP, ISO 13485, ICH guidelines and risk management principles.
• Proficiency in validation software, statistical analysis tools, and data integrity principles is a plus.
• Strong problem-solving skills with the ability to analyze technical issues and propose solutions.
• Excellent interpersonal, communication and documentation skills.
• Ability to work independently and in cross-functional teams in a fast-paced environment.