Validation Engineer

Job Description

Responsible for providing technical support to the Hydrox organization in terms of equipment/system/process qualification, validation, requalification and change management. Will participate in process and equipment improvement teams charged with enhancing the compliance and performance of plant systems, while managing the regulatory requirements for change control. The ability to write protocols and reports clearly, concisely and accurately; accurately record data and a basic understanding of statistical analysis is also required to perform these duties. Manages the company calibration/metrology program. Weekends and Off-shift hours are periodically required.

Duties & Responsibilities

· Develop and maintains validation master plans, process flow diagrams, test cases, and Standard Operating Procedures (SOPs).

· Develops and improves validation programs as needed to remain current with cGMPs and industry standards.

· Represents Quality in teams assembled to specify, procure, install, qualify, validate, troubleshoot and maintain production systems, equipment and processes.

· Develops and maintains calibration schedules for all necessary equipment in product manufacturing.

· Direct validation activities, such as protocol creation, scheduling, testing, assessment, reporting and archiving.

· Design validation study features such as sampling, testing, or analytical methodologies.

· Prepare validation or performance qualification protocols for new or modified manufacturing processes, systems, utilities, equipment, cleaning processes, computer, and new products for pharmaceutical production.

· Coordinate the implementation or scheduling of validation testing with affected departments and personnel.

· Conduct validation or qualification tests of new or existing processes, equipment, or software in accordance with internal protocols and external standards.

· Programs and operates department analytical instruments (such as temperature/humidity data loggers) to perform controlled temperature/humidity qualifications (examples warehouses, sterilizers, incubators, etc.).

· Analyze validation test data to determine whether systems or processes have met validation acceptance criteria or to identify root causes of production problems.

· Prepare detailed reports or design statements based on results of validation and qualification tests or reviews of procedures and protocols.

· Conduct audits of validation or performance qualification processes to ensure compliance with internal and regulatory requirements.

· Conducts and/or participates in deviation investigations to identify root causes and define corrective and/or preventive actions (CAPA).

· Create, populate, and maintain databases for tracking validation activities and qualified/validated systems.

· Identify deviations from established product or process standards and provide recommendations for resolving deviations through technical change control and/or requalification.

· Resolve testing problems by modifying testing methods or revising test objectives and standards.

· Study product characteristics or customer requirements and confer with management to determine validation objectives and standards.

· Assist in training equipment operators and other staff on validation protocols and standard operating procedures.

· Maintain validation test equipment and manage the company calibration program, activities, scheduling and documentation.

· Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or novel technologies.

· Other duties as assigned.

Knowledge, Skills and Abilities

· Generation of protocols, reports, deviations and other technical documents.

· PC literate with standard MS-Office application (Word, Excel, PowerPoint, Project, Access) competency.

· Understanding of statistical analysis tools and methods. ASQ-CQE certification preferred.

· Knowledge and understanding of cGMPs and industry guidance. Preferred 3-5 years of related experience in a cGMP facility. Pharmaceutical manufacturing experience preferred.

· Knowledge of calibration metrology processes.

· Knowledge of cGMP Equipment Qualification requirements and techniques.

· Knowledge of cGMP Cleaning Validation requirements and techniques.

· Knowledge of cGMP Process and Product Validation requirements and techniques.

Qualifications

· 4-year degree in a Science or Engineering field of study; or equivalent experience.

· Previous experience in CAPA, root-cause analysis, risk assessment, investigation tools and techniques.

· Previous work experience in an FDA regulated facility.

Working Condition

Work is performed in both an office environment and an FDA-regulated manufacturing facility, requiring frequent interaction with production, laboratory, warehouse, and maintenance personnel. Regular exposure to manufacturing equipment, packaging lines, utilities, and production processes is expected. The position may require entering production areas with varying temperatures, noise levels, and occasional exposure to chemical odors. Appropriate personal protective equipment (PPE) must be worn as required.

The Validation Engineer is expected to spend extended periods sitting, standing, walking, and using a computer and other office equipment. The role requires the ability to inspect equipment, access confined or elevated areas using stairs or ladders when necessary, and occasionally bend, reach, kneel, or crouch while performing validation activities. The ability to occasionally lift and carry up to 25 pounds is required. Occasional work outside of normal business hours may be necessary to support validation activities, equipment qualifications, or production schedules.

This job description lists the major duties and requirements of the job and is not all-inclusive. Incumbent may be expected to perform job-related duties other than those contained in this document and may be required to have specific job-related knowledge and skills.

Job Type: Full-time

Pay: $85,000.00 - $100,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Experience:

• Validation: 4 years (Required)
• Pharmaceutical Industry: 2 years (Required)

Work Location: In person

Salary : $85,000 - $100,000