Validation Engineer

SUMMARY:

Responsible for ensuring that all products, processes, and systems meet regulatory and quality standards through rigorous testing and analysis. Collaborate with cross-functional teams to design, develop, and execute validation protocols, and generate validation reports to ensure compliance with regulatory requirements.

Work Schedule: Monday - Friday 8am-5pm, OT required per project needs

JOB QUALIFICATIONS:

• B.S. (or equivalent 4-year degree) in Engineering or Science Related Field
• Minimum of 5 years validation experience supporting pharmaceutical cGMP manufacturing and/or technical support operations
• Experience with Liquid, Solids, Medical Devices and Semisolid Dosage Forms
• Experience authoring, executing and summarizing validation qualification protocols
• Experience with Cleaning Validation including swabbing and reinstate sampling
• Regulatory inspection experience with external regulatory authorities
• Knowledge of the principles and application of statistical analysis preferred
• Technical writing and attention to detail required
• Trained and experienced on Validation (Product Life Cycle), Start-Up, Equipment Evaluation, Selection and Commissioning
• Extensive knowledge on Technical Investigations and Product/Process Development/Optimization.
• Experience in administrative techniques, Vendor Qualifications
• Knowledge of the principles and application of cGMP guidelines related to validation activities
• Time management and ability to handle multiple tasks on time
• Relies on extensive experience and judgment to plan and accomplish goals
• Computer literate • Strong conflict resolution skills
• Strong communication skills - verbal and written
• Strong collaboration and teamwork
• Willingness in traveling

POSITION RESPONSIBILITIES:

• Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis
• Validate new and re-validate as appropriate existing equipment used in OTC/Rx manufacturing, packaging, compose reports and make adjustments to equipment or processes that require improvement
• Evaluate, implement and monitor processes, operating systems, critical utilities, manufacturing and packaging equipment in accordance with appropriate regulatory agency validation requirement and current industry practices
• Create/edit/maintain necessary documentation that pertain to the Evaluation of the Process Qualification PPQ/Manufacturing & Packaging Equipment Qualification and the Status of the Critical Utilities (HVAC, USP DI Water Compress Air System) as well as any other utilities that affect directly the Critical Products Attributes
• Evaluation of the Critical Utilities, Manufacturing and Packaging Equipment calibration and maintenance monitoring during the execution of these systems Qualification
• Evaluation of existing and/or creation of Cleaning, Operation Procedures for the critical utilities, manufacturing and packaging equipment.
• Assess the availability of raw materials and their impact in a specific manufacturing process not only from the process influence but also from the safety and environmental influence of the facility related to this material
• Support the conversion during the “Scale Up” of any Manufacturing Process that has been developed at a small-scale process into commercially viable large-scale commercial operations
• Coordinate and responsible of all New Molecules transfers from R&D bench/pilot size to the manufacturing.
• Monitor and improve the efficiency, output and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel
• Coordinate projects directly with vendors and service providers to ensure that all validation and installation requirements are being satisfied during the execution of protocols
• Work closely with other specialists (including scientists) for quality control of raw materials.
• Measure instrument or software performance to determine if tools are performing as described for temperature mapping, and calibration activities
• Provide validation support for Computerized Systems including Automation and Laboratory Equipment and qualification / validation activities of Primary / Secondary manufacturing operations
• All other duties, as assigned

PHYSICAL REQUIREMENTS:

• Assume responsibility for safety/environmental issues during an ongoing performance qualification of a manufacturing process
• Must be able to lift and carry light loads as necessary in conducting testing
• Weekend or long hours based on testing schedule
• May involve standing for long periods of time
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements