Validation Engineer

Job Description for Validation Engineer

Role Summary

The purpose of the Validation Engineer is to ensure that products, equipment, and systems meet all applicable safety, quality, and regulatory requirements. They do this by developing and implementing validation plans, conducting tests, analyzing data, and documenting results.

Essential Duties & Responsibilities:

• Assists with developing qualification protocols, and associated reports while adhering to a change management process.
• Supports the execution of equipment/systems qualifications and validation protocols.
• Supports vendor's qualification functions.
• Assists with developing written procedures for operation and preventive maintenance of equipment and systems.
• Assists with developing validation/qualification deliverables such as Requirements Specifications, Risk Assessments, Traceability Matrices, and validation Summary Reports.
• Supports internal groups in the procurement, operation, calibration, and preventive maintenance of equipment/systems to meet business needs in accordance with required schedules or dates.
• Completes all calibration, qualification, and validation documentation with accuracy, completeness, and compliance.
• Regularly reviews, prioritizes, and promptly responds to MFG and QA equipment qualification/system validation and support requests.
• Maintains a positive relationship with all team members while promoting a positive team environment.

Position Requirements:

• BS degree (minimum) in engineering or biological sciences.
• 2+ years of experience in validation, and quality assurance in Pharmaceutical field
• 1+ years of direct experience in the Equipment validation/qualification, utility and facility qualifications
• Hands on experience working with GAMP 5 systems and 21 CFR Part 11 compliance.
• Demonstrated ability to interpret and apply pharmaceutical industry regulatory compliance requirements with an emphasis on US and EU/MHRA data integrity guidance.
• Ability to work as part of a cross-functional team in a dynamic, fast-paced environment.
• Ability to effectively communicate with team members, contractors and vendors.

Employment Classification

• Full-time

Location

• Hauppauge or Central Islip, NY locations

Physical Requirements

• This position requires the ability to do heavy lifting / bending frequently.
• Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.
• Ability to perform repairs to parts or equipment that may require cutting, brazing, TIG/MIG or stick welding.
• Requires the ability to work indoors and outdoors.
• Must be physically capable of climbing ladders, working with hardware, working in a lying position, working with arms extended overhead for extended periods of time.
• Ability to wear appropriate PPE is required.
• Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Company

• In the last 85 + years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on the expanse of our strong legacy. We articulated our 2022 winning aspiration to double the number of patients we serve and hence, double the impact we create as a global pharmaceutical company. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. We at Cipla are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. We are looking for talented individuals to grow their careers while growing our business.

EEO Statement

• Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.