GMP Equipment Commissioning & Qualification Engineer

SOKOL GxP Services; Utah; On-site; USD 77,000 - 84,000; Full time

Benefits offered by this job

Health insurance

401(k) program

Holiday pay

Employee referral bonus

Possible contract extension

Client may hire contractor

Job summary

SOKOL GxP Services seeks an Equipment Commissioning & Qualification Engineer for a GMP-regulated pharmaceutical site. The role covers commissioning through turnover, coordinating vendors and handling validation documentation.

Requires 5+ years in GMP, 3+ years in equipment qualification, and strong knowledge of cGMP, GxP, and 21 CFR Part 11. Onsite in Summit, NJ with a 6-month W-2 contract and no visa sponsorship.

Qualifications

• Minimum 5 years in a GMP-regulated environment.
• Minimum 3 years in equipment/facilities/utilities qualification.
• Experience developing and executing commissioning/qualification/validation protocols and reports.
• Prepare qualification deliverables: Validation Plans, Requirements/Design Specifications, Traceability Matrices, Summary Reports.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, computerized systems validation, and good documentation practices.
• Knowledge of pharmaceutical manufacturing and lab systems.
• Understanding investigations, deviations, CAPA, and change management in a regulated pharma environment.
• Ability to supervise vendors and manage equipment implementation/qualification activities.
• Ability to manage multiple projects and priorities in a fast-paced environment.
• Strong written/ verbal/ organizational/ analytical/ interpersonal skills.
• Proficiency in Word, Excel, PowerPoint, Outlook, and databases.
• Authorization to work in the United States without visa sponsorship.

Responsibilities

• Develop and execute commissioning, qualification, or validation protocols and associated reports.
• Prepare qualification deliverables such as VPs, requirements/design specs, and summary reports.
• Coordinate external vendors and support equipment implementation from site prep to turnover.
• Support change management, equipment lifecycle activities, and deviation investigations.
• Troubleshoot technical issues and assist investigations in a regulated environment.
• Manage multiple projects and priorities in a fast-paced GMP setting.

Skills

GMP experience

Equipment qualification

Validation protocols

Documentation

Vendor management

Regulatory compliance

cGMP knowledge

Pharma systems knowledge

Investigations/ CAPA

Project prioritization

MS Office & databases

Education

Bachelor's degree in Engineering

Tools

ValGenesis

MS Office (Word/Excel/PowerPoint/Outlook)

Job description

SOKOL GxP Services seeks an Equipment Commissioning & Qualification Engineer for a GMP-regulated pharmaceutical site. The role covers commissioning through turnover, coordinating vendors and handling validation documentation.

Requires 5+ years in GMP, 3+ years in equipment qualification, and strong knowledge of cGMP, GxP, and 21 CFR Part 11. Onsite in Summit, NJ with a 6-month W-2 contract and no visa sponsorship.