New · posted Nov 11
Alvogen · Pharmaceuticals
Validation Engineer I
- Norwich, NY
- On-site
- Full-time
- Associate & Specialist
The role
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.
What you need
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.
What you'll do
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
Pay and benefits
$75,000 – $83,000 a year
Employer providedGMP 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 and comprehensive benefits package, consisting of medical and prescription drug coverage (two PPO plans and an HDHP with Health Savings Account and employer contribution), dental, vision, flexible spending accounts. Alvogen’s benefits package also includes a retirement savings program, long-term care coverage, paid time off (176 hours to start) inclusive of sick time, disability benefits, life insurance, a wellness program, and 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. To apply, select the apply button and submit your application.
Medical and prescription drug coverage
Dental and vision
Retirement savings program
Paid time off (176 hours to start)
13 paid holidays
Annual discretionary bonus
Where you'll work
Norwich, NYOn-siteOpen in Maps (opens in a new tab)
More jobs in Norwich, NYEqual opportunity, accessibility and legal noticesAlvogen's statements, word for word
“An Equal Opportunity Employer, including disability/vets.”
Job intelligence
The context around this role
Live data · November 11, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Validation & CQV roles at this level.
This roleEmployer provided
Associate & Specialist roles in New York8 roles publishing pay
Associate & Specialist roles in the US20 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $75,000 | — | $83,000 |
| New York (middle half) | $63,750 | $77,000 | $81,875 |
| All US (middle half) | $69,375 | $78,500 | $91,500 |
This role: Alvogen's own published range. Comparisons: the base pay employers published on open Validation & CQV roles at the same level on Regulatory Jobs, November 11, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Validation & CQV
The general path across 97 open Validation & CQV roles on Regulatory Jobs, with the titles they carry most. Not Alvogen's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 19 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Validation and qualification13
- Documentation and SOPs10
- Data and digital systems4
- Lab testing and methods3
- Quality systems and risk3
- Collaboration and leadership3
- GMP and compliance1
- Clinical trial conduct1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Validation & CQV work in pharmaceuticals, each linked to the agency or standards body that publishes it.
- FDAFDA process validation guidance(official source, opens in a new tab)Process Validation: General Principles and Practices
- FDA21 CFR Parts 210 and 211(official source, opens in a new tab)FDA current good manufacturing practice for finished pharmaceuticals
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- ISPEISPE GAMP 5(official source, opens in a new tab)A risk-based approach to compliant GxP computerized systems
- ASTMASTM E2500(official source, opens in a new tab)Specification, design and verification of pharmaceutical manufacturing systems and equipment
- ICHICH Q9(R1)(official source, opens in a new tab)Quality risk management
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- ISOISO 19011(official source, opens in a new tab)Guidelines for auditing management systems
- EUEU GMP (EudraLex Volume 4)(official source, opens in a new tab)The EU's good manufacturing practice rules, including Annex 1 sterile and Annex 15 validation
- FDAFDA data integrity guidance(official source, opens in a new tab)Data Integrity and Compliance With Drug CGMP: Questions and Answers
- FDAFDA aseptic processing guidance(official source, opens in a new tab)Sterile Drug Products Produced by Aseptic Processing: Current Good Manufacturing Practice
- ISOISO 14644-1(official source, opens in a new tab)Cleanroom air cleanliness classification by particle concentration
- ICHICH Q2(R2) and Q14(official source, opens in a new tab)Validation and development of analytical procedures
- FDAFDA analytical procedures guidance(official source, opens in a new tab)Analytical Procedures and Methods Validation for Drugs and Biologics
- ICHICH Q8(R2)(official source, opens in a new tab)Pharmaceutical development and quality by design
- ICHICH Q10(official source, opens in a new tab)The pharmaceutical quality system across the product lifecycle
Company hiring pulse
Alvogen on Regulatory Jobs
- 2
- Open roles
- 2
- Distinct roles
- 1
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Validation Engineer I at Alvogen
Open until filled. $75K–$83K a year, employer provided.