Validation Support Specialist

Responsibilities:

The Validation Support Specialist is responsible for performing qualification and/or validation activities to support the cGMP biopharmaceutical/ pharmaceutical manufacturing at NJ Bio. This role is responsible for writing and executing protocols for process equipment and facility systems, as well as process and cleaning validations. The Validation Support Specialist conducts qualification/validation activities for projects within timelines and complies with the requirements of NJ Bio’s EHS requirements, OSHA requirements, applicable cGMPs and other regulations. The Validation Support Specialist will assist in review of all documents which support the qualifications. The incumbent works cross-functionally with internal departments and external resources on validation/ qualification related issues. The Validation Support Specialist supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. 

• Assists with the development of Validation Master Plans
• Prepares installation, operational and performance qualification protocols for new or modified processes, systems, or equipment in support of the GMP manufacturing process.
• Works independently to execute, or cordinate execution of, validation protocol activities with affected departments, personnel and/or third-party vendors.
• Develop and execute protocols for Process and Cleaning validations.
• Assists with computer validation to meet FDA 21CFR part 11 compliance.
• Performs risk assessments, root cause investigations; write deviations, change controls, and CAPAs, and/or assist with the writing based on sound engineering principles.
• Performs reviews of URS, SOP and documents supporting the qualification activities
• Assist with authoring SOPs and Work Instructions as applicable.
• Maintain communication with cross-functional teams including Manufacturing, Facilities, Quality Assurance, and Project Management to achieve all project deliverables.
• Maintain databases for tracking validation activities.
• Perform other tasks and assignments as needed and specified by management.

Requirements:

Required Knowledge, Skills and Abilities:

• Able to do participate in cleanroom gowning and PPE, as required by site procedures.
• Is passionate about continuous improvement.
• Able to understand and verify piping & instrument diagram, engineering layout, drawing and other engineering documents.
• Knowledge of Good Documentation Practices, Pharma GxPs, cGMPs, Engineering Qualification Procedures, tools for Risk Assessment, FMEA, others are a must.
• Proficiency with Microsoft Office
• Excellent verbal communication, technical writing and presentation skills as well as interpersonal skills.
• Ability to work independently and collaboratively, as required, in a team environment consisting of internal and external team members.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
• Ability to work outside of normal business hours, including occasional nights, weekends or holidays, as needed to fulfill the business need.

Education and Experience Requirements:

• Bachelor’s degree in engineering, pharmaceutical manufacturing, chemistry, biotechnology, or related scientific discipline required.
• A combination of equipment qualification, process validation, cleaning or computer validation may be acceptable
• Stays abreast of Industry guidelines, US and international regulations for validation of GMP facilities.

Physical Demands:

N/A

Working Conditions:

Office based position

NJ Bio, Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.