Validation Engineer I: Equipment & Facility Systems

Norwich Pharmaceuticals; City of Norwich (NY); Sur place; USD 75 000 - 83 000; Plein temps

Avantages offerts par ce poste

Annual discretionary bonus

Medical and prescription drug coverage

Dental and vision

Health Savings Account with employer

Paid time off 176 hours

13 paid holidays

Résumé du poste

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.

Qualifications

• 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.

Responsabilités

• 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.

Connaissances

Technical writing

Communication skills

MS Excel proficiency

MS Word proficiency

Multitasking

Formation

Bachelor's Degree in science or Engineering

Outils

MS Excel

MS Word

Description du poste

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.