Senior Validation Engineer

Piper Companies; Copiague (NY); On-site; USD 85,000 - 95,000; Full time

Job summary

Join a leading pharmaceutical manufacturing company as a Senior Validation Engineer, where your expertise will ensure compliance in a cGMP environment. This role involves managing end-to-end validation processes, supporting qualification tasks, and overseeing validation activities across shifts. You will contribute to critical decision-making on validation strategies while ensuring adherence to FDA regulations. With a competitive salary range and comprehensive benefits, this position offers a dynamic work environment where you can thrive and make a significant impact in the industry. If you are passionate about validation and eager to take on new challenges, this opportunity is perfect for you.

Benefits

Medical insurance

Dental insurance

Vision insurance

401K

Paid Time Off (PTO)

Sick Leave

Holidays

Qualifications

• 5+ years of experience in validation, tech transfer, and leadership in the pharmaceutical industry.
• Knowledge of FDA regulations and guidelines, with strong technical writing skills.

Responsibilities

• Manage hands-on validation for products, processes, and equipment.
• Prepare, review, and organize validation protocols and reports.

Skills

Validation in pharmaceutical industry

Technical writing

Communication skills

Ability to manage multiple tasks

Education

Engineering or Science related 4-year degree

Tools

Office 365

Oracle

QMS

Job description

Piper Companies is seeking a Senior Validation Engineer to join a leading pharmaceutical manufacturing company located in Long Island, NY. The Senior Validation Engineer will ensure compliance by developing and executing testing protocols for equipment, processes, and utilities in a pharmaceutical cGMP environment.

Responsibilities of the Senior Validation Engineer include:

• Manage end to end, hands on, validation for products, processes, equipment and packaging
• Supports all qualification tasks related to manufacturing equipment – IQ/OQ/PQ
• Provide decisions on validation strategies and performance issues
• Prepare, review and organize validation protocols and reports
• Schedule and oversee validation tasks across all shifts
• Support inspections and ensure cGMP compliance

Qualifications for the Senior Validation Engineer include:

• 5+ years of experience in a pharmaceutical industry role, including experience in validation, tech transfer and leadership
• Equipment and Cleaning validation (preferred), with knowledge of FDA regulations and guidelines.
• Proficiency in validation tools and software, including Office 365, Oracle, QMS, statistical/process validation methods (preferred)
• Strong technical writing, verbal and written communication skills
• Ability to manage multiple tasks, work independently, and thrive in a fast-paced environment with changing priorities
• Engineering or Science related 4-year degree required

Compensation for the Senior Validation Engineer includes:

• Salary Range: $85,000 - $95,000 **Depending on experience**
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave if required by law, and Holidays

This job opens for applications on 2/10/2025. Applications for this job will be accepted for at least 30 days from the posting date.