Validation Engineer I

Norwich Pharmaceuticals; City of Norwich (NY); Presencial; USD 75.000 - 83.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual discretionary bonus

Medical and prescription drug coverage

Dental and vision

Health Savings Account with employer

Paid time off 176 hours

13 paid holidays

Descripción de la vacante

Norwich Pharmaceuticals is seeking a Validation Engineer to lead and support critical validation activities across Equipment, Facilities, and Process systems. You will author, review, and approve qualification documents, participate in risk assessments, and ensure compliance with GMP requirements.

You will prepare protocols and reports, provide training, support audits, and contribute to Master Validation Plans and Periodic Review processes.

Formación

• Bachelor's Degree in science or Engineering field.
• Minimum of 3 years related pharmaceutical experience, preferably in manufacturing Equipment Engineering and Validation.
• Strong technical writing and communication skills with ability to interpret technical documentation.
• Proficiency with a currently supported version of MS Excel and Word; ability to handle multiple priorities.

Responsabilidades

• Provide primary coverage for Equipment and Instrumentation Qualification - write, review, and approve commissioning/qualification documentation.
• Provide primary coverage for Facility and Utility Qualification - write, review, and approve commissioning/qualification documentation.
• Manage periodic review of validated systems, equipment, and utilities; organize assessment process.
• Represent/Support the department in audits or regulatory inspections; field questions on systems and programs.
• Facilitate and/or support validation training on the above systems.
• Provide backup coverage for Packaging Validation.
• Co-own and input to Validation Master Plans for Site, Computer System Validation, Equipment, Laboratory Instrumentation, Facility, and Utility Qualifications.
• Provide backup coverage on Computer System Validation (CSV) including Electronic Records and Electronic Signatures; lead risk assessments and supplier assessments; write/review/approve related documentation.
• Provide APR support specific to Validation and Change Control.

Conocimientos

Technical writing

Communication skills

MS Excel proficiency

MS Word proficiency

Multitasking

Educación

Bachelor's Degree in science or Engineering

Herramientas

MS Excel

MS Word

Descripción del empleo

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 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.

"An Equal Opportunity Employer, including disability/vets."