Validation Engineer

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. The candidate will also be responsible for generating and executing the site validation master plan.

This position has no direct reports.

RESPONSIBILITIES:

Performs validation studies on manufacturing equipment, including equipment set up and qualification, manufacturing process validation, as well as cleaning validation, and ensuring 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

- Evaluating 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

- Generate data and reports for the validation periodic monitoring and re-qualification programs

- 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.

- Represents the engineering process during customer, certification and regulatory audits (internal and external)

- Assist in investigating deviations related to facilities, utilities, and equipment.

- Participates in multi-functional department teams for facilities, utilities, and equipment to meet established project timelines; says 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.

- Other duties as assigned by management.

QUALIFICATIONS:

Required

- 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.

Preferred

- Must have the ability to work both independently and as a greater team. Must be able to coordinate work with customers, supervisors, and information partners frequently in different states and/or countries.

- Must be able to work in a fast-paced environment. Must be able to manage multiple projects while minding priorities. Must be able to make informed, strategic decisions, even when under pressure or when working with resource limitations.

- Must always have a mindset to protect the interests and health of our consumers, our company, and our customers.

- Must work well cross-functionally, with partners from commercial, sales,…