Validation Engineer

Department: Validation

Job Title: Validation Specialist

Reports To: Validation Supervisor

1. Role Purpose:

Support site commissioning and qualification, equipment qualification, and process and assay validation by ensuring the timely development, execution and coordination of all validation activities pertaining to facility, equipment and process in compliance with Quality System requirements, site procedures and regulatory requirements. This role will develop validation and Quality System documentation (e.g. IQ/OQ/PQ/SOP/Change Controls/Deviations/CAPAs etc.). This role will organize all validation activities ensuring project completion per schedule requirements. Additionally, the Validation and Calibration Specialist will be required perform and support GMP instrument calibration activities and completion of the corresponding documentation.

2. Key Duties & Responsibilities:

• Maintain the Company’s compliance with established KVK Standard Operating Procedures and specifications and Current Good Manufacturing Practices.
• Write, execute and coordinate commissioning, qualification and validation protocol testing.
• Compile relevant commissioning/qualification/validation study data and generate summary reports to document the results of the studies.
• Aid in troubleshooting/impact assessment for atypical conditions during studies/ validations.
• Assist in the maintenance and development of any existing validation programs to ensure continued compliance with regulatory requirements.
• Provide scientific rationale/strategy for studies of new or modified GMP equipment and processes.
• Ensure all aspects of validation and qualification adhere to site and corporate policies and procedures, including safety and training.
• Review all errors, protocol deviations, and comments with the respective user department Management and QA and resolve discrepancies.
• Manage responsibilities and workload to assure accurate and timely data and reports.
• Perform scheduled preventive maintenance, and instrument calibrations.
• Document all instrument calibrations and equipment preventive maintenance.
• Complete any associated work order documentation.
• Review completed validation, PM, and calibration documentation for accuracy and GMP compliance.
• Comply with FDA guidelines, Site and Corporate Policies for Data Integrity.
• Other duties as assigned.

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

• Bachelor’s Degree preferred
• Technical discipline (sciences, engineering) or related field preferred
• Preferred to have 6-8 years of technical experience in validation in a GMP environment, including pharmaceutical manufacturing and project management.

5. Technical competencies/ Certifications/ Licenses:

• Ability to manage and plan multiple projects.
• Knowledge of cGMP’s, GDP’s and regulatory requirements as they related to qualification and validation activities (IQ/OQ/PQ).
• Possess a working knowledge of Microsoft Word, Windows, Excel, Power Point, and Statistical tools such as Minitab/Jmp.
• Must possess excellent analytical skills, good problem-solving technique and data analysis skills using Excel.
• Employee must have excellent communication skills, both written and verbal
• Employee must be collaborative when working with groups.
• Attention to detail is required.

6. Physical demand and Work environment:

a. Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b. Work environment:

N/A