Validation Engineer I

Alvogen • Norwich, NY

4h • $75,000 - $83,000

About The Position

The Validation Engineer I authors and provides input to critical validation systems and conducts validation assessments of equipment, facilities, and process systems. The role compiles and analyzes data, prepares protocols and reports, and recommends changes or improvements. It serves as a primary resource for periodic equipment reviews and provides backup support for Packaging Validation, Computer System Validation, Equipment and Instrumentation Qualification, and Facility and Utility Qualification.

The position provides primary coverage for Equipment and Instrumentation Qualification and Facility and Utility Qualification, including writing, reviewing, and approving commissioning and qualification documentation and providing program oversight and guidance to maintain consistency and standards. It manages periodic reviews of validated systems, equipment, and utilities; supports audits and regulatory inspections; facilitates or supports validation training; contributes to site and functional Validation Master Plans; provides backup Computer System Validation support; and supports Annual Product Reviews related to Validation and Change Control.

The role authors, edits, and approves qualification and validation documents, APR supporting documents, periodic review documentation, and related Change Controls. It reports directly to the Sr. Director Operations & Pharmaceutical Technology. The anticipated base salary range is $75,000 to $83,000, and the position is eligible for an annual discretionary bonus and a comprehensive benefits package.

Requirements

• Bachelor’s degree in a science or engineering field of study.
• At least 3 years of related pharmaceutical experience.
• Technical writing and communication skills.
• Ability to understand and interpret technical documentation.
• Proficiency with a currently supported version of MS Excel and Word.
• Ability to handle multiple priorities.

Nice To Haves

• Pharmaceutical Manufacturing Equipment Engineering and Validation experience.

Responsibilities

• Provide primary coverage for Equipment and Instrumentation Qualification, including writing, reviewing, and approving commissioning and qualification documentation.
• Provide oversight and guidance for the Equipment and Instrumentation Qualification program to maintain consistency and standards.
• Provide primary coverage for Facility and Utility Qualification, including writing, reviewing, and approving commissioning and qualification documentation.
• Provide oversight and guidance for the Facility and Utility Qualification program to maintain consistency and standards.
• Manage periodic reviews of validated systems, equipment, and utilities, including maintaining the system and organizing the assessment process.
• Represent and support the department during audits or regulatory inspections, answering questions related to the applicable systems and programs.
• Facilitate or support validation training for the applicable systems.
• Provide backup coverage for Packaging Validation.
• Co-own and provide input to Validation Master Plans for the site, Computer System Validation, Equipment, Laboratory Instrumentation, Facility, and Utility Qualifications.
• Provide backup Computer System Validation coverage, including conducting electronic records and electronic signature assessments, leading and assessing risk assessments, evaluating supplier assessments, and writing, reviewing, and approving associated documentation.
• Provide Annual Product Review support related to Validation and Change Control as needed.
• Author qualification and validation documents, edit and approve associated documentation, author APR supporting documents, author periodic review documentation for validated systems, and author related Change Controls for systems and processes.

Benefits

• Annual discretionary bonus eligibility.
• Medical and prescription drug coverage, including two PPO plans and an HDHP with Health Savings Account and employer contribution.
• Dental coverage.
• Vision coverage.
• Flexible spending accounts.
• Retirement savings program.
• Long-term care coverage.
• Paid time off, 176 hours to start, inclusive of sick time.
• Disability benefits.
• Life insurance.
• Wellness program.
• 13 company-recognized paid holidays per year.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level