Validation Engineer I

Alvogen; City of Norwich (NY); On-site; USD 75,000 - 83,000; Full time

Benefits offered by this job

Medical and prescription drug coverage

Dental

Vision

Retirement savings program

Paid time off

Job summary

Alvogen is seeking a Validation Engineer in New York to author and review qualification documents, develop protocols, and oversee periodic reviews of validated systems. The role includes supporting audits, providing training input, and backing up packaging validation.

The ideal candidate has a science/engineering degree and at least 3 years in pharmaceutical validation, with strong MS Excel/Word skills and the ability to manage multiple priorities.

Qualifications

• Bachelor's Degree in science or Engineering.
• Minimum 3 years related Pharmaceutical experience.
• Strong technical writing and communication skills.
• Proficiency with MS Excel and Word.

Responsibilities

• Author and review qualification documentation.
• Develop validation protocols and reports.
• Maintain periodic review of validated systems.
• Support audits/regulatory inspections.
• Provide backup coverage for packaging validation.
• Co-own validation master plans.

Skills

Technical writing

Communication

Prioritization

Education

Bachelor's degree in science or engineering

Tools

Excel

Word

Job description

Summary Of Position

Author and provide input to critical Validation systems and conduct validation assessments of equipment, Facilities, and process systems. Compile and analyze data, prepare protocols, reports, and make recommendations for changes/or improvements. A primary resource for Periodic Equipment review systems. In addition, provide secondary/Backup support for Packaging Validation, Computer System Validation, Equipment and Instrumentation qualification, Facility, and Utility qualification.

ORGANIZATION STRUCTURE

The Validation Engineer reports directly to the Sr. Director Operations & Pharmaceutical Technology.

Responsibilities

Primary responsibilities of this role include the following:

System/Process

• Provide primary coverage on Equipment and Instrumentation Qualification- write, review, approve commissioning/qualification documentation. Provide Oversite and guidance on the program to maintain consistency and standards.
• Provide primary coverage on Facility and Utility Qualification- write, review, approve commissioning/qualification documentation. Provide Oversite and guidance on the program to maintain consistency and standards.
• Manage the periodic review of validated systems, equipment, and Utilities. Maintaining the system and organizing the assessment process.
• Represent/Support the Department in audits or regulatory inspections fielding questions related to the above systems and programs.
• Facilitate and/or support validation training on the above systems.
• Provide Backup Coverage for Packaging Validation.
• Co-Own and provide input to the Validation Master Plans for the Site, Computer System Validation, Equipment, Laboratory Instrumentation, Facility, and Utility Qualifications.
• Provide backup coverage on Computer System Validation performing Electronic records and Electronic Signature assessments, lead and assess risk assessments, evaluate supplier assessments, write, review, approve associated documentation.
• Provide Annual Product Review (APR) Support specific to Validation and Change Control as needed.

Documentation

• Author Qualification and Validation Documents
• Edit and approve associated documentation
• Author APR supporting documents
• Author Periodic Review of validated systems documentation
• Author related Change Controls for systems and processes

Qualifications

Bachelor's Degree in science or Engineering Field of study

A minimum requirement of 3 years related Pharmaceutical experience- preference for Pharmaceutical Manufacturing Equipment Engineering and Validation experience.

This role requires technical writing and communication skills, the ability to understand and interpret technical documentation and a proficiency with a currently supported version of MS Excel and Word. The ability to handle multiple priorities is necessary for success.

GMP DECISION-MAKING AUTHORITY

• Inputs/Edits Validation and Qualification documentation- serves as resource in the development and approval of documentation.
• The technical approver for protocols and executed qualifications.
• Subject Matter Expert approver for related Change Controls.

The anticipated base salary range for this position is $75,000 to $83,000.

This position is eligible for Alvogen's annual discretionary bonus.

• Medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution)
• Dental
• Vision
• 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

We anticipate this position will be posted on 11/10/2026 and remain open for at least 30 days.

An Equal Opportunity Employer, including disability/vets.