Validation Engineer

Validation Engineer II

Calculated Hire is working with a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

SUMMARY:

The Validation Engineer II is responsible for establishing validation standards, developing and executing testing protocols, and ensuring compliance with regulatory requirements in a pharmaceutical cGMP manufacturing environment. This role involves validating new and existing equipment, monitoring processes and critical utilities, and coordinating with vendors and service providers for equipment installation and validation. Strong technical writing, collaboration, and time management skills are essential, along with experience in validation and equipment qualification. The role may require occasional travel and work in manufacturing areas under varying physical conditions.

Work Schedule: Monday - Friday 8am-4:30pm

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 Solids or Semisolid Dosage Forms.
• Experience authoring, executing and summarizing validation qualification protocols and reports.
• Experience with Cleaning Validation including swabbing and rinse sampling.
• Knowledge of the principles and application of statistical analysis preferred.
• Ability to analyze, investigate, and propose approaches in process, utility, equipment, and cleaning validation along with ability to write risk assessments.
• Excellent 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 and Optimization.
• Knowledge of the principles and application of cGMP guidelines related to validation activities.
• Regulatory inspection experience with external regulatory authorities preferred.
• Time management skills and ability to handle multiple tasks on time.
• Proactive with the ability to work independently, self-motivated and organized.
• Relies on extensive experience and judgment to plan and accomplish goals.
• Must have prior knowledge of instrumentation used in qualification activities such as tachometer, multimeter, pressure gauge, balance/scales, pH meter, vacuum gauge, etc.
• Must be proficient in Office 365 applications (Word, Excel, Outlook, PowerPoint).
• Leadership skills required with the ability to lead validation projects in coordination with cross-functional team including operations, engineering, and quality.
• Ability to work in a fast paced environment while supporting multiple and changing priorities.
• Strong verbal and written communication skills required.
• Strong conflict resolution skills.
• Strong collaboration and teamwork.
• Willingness for minimal travel.

POSITION RESPONSIBILITIES:

• Responsible for risk analysis, process validation, cleaning validation and equipment qualification required for new products, processes and equipment and any changes to existing products, processes and equipment.
• Establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis.
• Prepare and review all protocols and reports for validation work.
• Author annual Site Validation Master Plan.
• Responsible for cleaning validation / verification activities.
• Represent Validation Department at site change control board meetings.
• 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.
• Evaluate the Critical Utilities, Manufacturing and Packaging Equipment calibration and maintenance monitoring during the execution of these systems Qualification.
• Evaluate existing and/or help create Cleaning, Operation Procedures for the Critical Utilities, Manufacturing and Packaging Equipment.
• 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.
• Provide technical decision-making regarding validation strategies and requirements for projects.
• Provide recommendations for product disposition or other actions related to product issues and equipment performance issues.
• Coordinate all validation activities by constant communication with affected departments and personnel. This includes scheduling and execution of activities as it pertains to validation projects.
• Execute, oversee, and review validation area processes and procedures.
• Control and organize all validation documents.
• 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.
• Assist with 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.
• 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:

• This position is primarily sedentary, working at a desk or in attending meetings.
• Work safely and adhere to all OSHA regulations as well as company safety policies and procedures.
• Work in a manufacturing environment, when necessary.
• Exposure to vitamins, mineral, herbal, and OTC products; No allergies.
• Must be able to wear proper gowning and PPE in manufacturing areas as required to meet GMP and/or OSHA requirements.
• May be exposed to moderate noise levels, in manufacturing areas.
• May be exposed to dust, fumes, and disagreeable odors, in manufacturing areas.
• Occasionally lift and/or move up to 35 pounds.
• Walking including in/around automated equipment.
• Occasionally stand and/or walk short distances for long period of time.
• Weekend or long hours based on testing schedule.