Pharma Validation Engineer I — Systems & Compliance

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 insurance

Vision insurance

Health Savings Account (HDHP with HSA)

Retirement savings program

Paid time off 176 hours ( PTO )

Sick time

Disability benefits

Life insurance

Wellness program

13 paid holidays

Job summary

Alvogen is seeking a Validation Engineer to author and validate equipment, facilities, and process systems. You will analyze data, prepare protocols, and provide recommendations for improvements.

The role includes backup support for Packaging and Computer System Validation, and participation in audits and change controls. You will co-own Validation Master Plans, write qualification documents, and lead risk assessments.

Qualifications

• Bachelor’s degree in science or engineering is required.
• Minimum 3 years in pharmaceutical experience with equipment validation.
• Strong technical writing and communication skills; proficient with MS Excel and Word.

Responsibilities

• Author and review qualification and validation documents.
• Edit and approve related documentation and APR supporting documents.
• Provide primary coverage for Equipment and Instrumentation Qualification; oversee programs for consistency.
• Provide backup coverage for Packaging Validation and for Computer System Validation.
• Contribute to Validation Master Plans and risk assessments; support annual product reviews.

Skills

Technical writing

MS Excel

MS Word

Education

Bachelor’s Degree in science or Engineering

Job description

Alvogen is seeking a Validation Engineer to author and validate equipment, facilities, and process systems. You will analyze data, prepare protocols, and provide recommendations for improvements.

The role includes backup support for Packaging and Computer System Validation, and participation in audits and change controls. You will co-own Validation Master Plans, write qualification documents, and lead risk assessments.