Equipment Engineer

Creative Solutions Services, LLC; Summit (NJ); On-site; USD 110,000 - 150,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an Equipment Engineer specializing in ECQ to support commissioning, qualification, and validation of pharmaceutical equipment within a GMP environment. The role ensures equipment remains commissioned and qualified and collaborates with internal teams and external providers on implementation projects.

The position emphasizes developing protocols, supervising qualification work, and maintaining documentation in line with regulatory standards.

Qualifications

• BS in Engineering or Science or equivalent experience.
• Minimum 5 years in a GMP environment.
• Minimum 3 years in equipment, facilities, or utilities qualification.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, CSV, and Good Documentation Practices.
• Understanding of investigations, deviations, and CAPA in pharma.

Responsibilities

• Maintain commissioned/qualified equipment, facilities, and utilities in compliance.
• Develop commissioning/qualification protocols and reports.
• Supervise vendors performing qualification activities.
• Support development of equipment operational procedures.
• Execute equipment qualification and validation protocols.
• Prepare Validation Plans, Requirements Specifications, Design Specs, Traceability Matrices, and Summary Reports.
• Assist Change Management processes.
• Support equipment implementation projects from scheduling to turnover.
• Oversee operation, calibration, and preventive maintenance.
• Complete qualification and validation documentation accurately and in compliance.

Skills

GMP experience

Documentation practices

Written and verbal communication

Multitasking

Project management

Education

BS in Engineering or Science

Equivalent relevant experience

Tools

ValGenesis

Database systems

Microsoft Office Suite

Job description

Job Summary:

• The Equipment Engineer (Equipment Commissioning & Qualification - ECQ) supports the successful implementation, commissioning, qualification, and maintenance of equipment, instruments, facilities, and utilities in a GMP-regulated pharmaceutical environment.
• The role is responsible for ensuring equipment remains in a commissioned, qualified, and validated state while supporting equipment implementation projects, qualification activities, compliance, and collaboration with internal teams and external service providers.

Roles & Responsibilities:

• Maintain commissioned/qualified equipment, facilities, and utilities in compliance with policies, guidelines, and procedures.
• Develop commissioning/qualification protocols and associated reports while adhering to change management processes.
• Supervise vendors performing qualification activities.
• Support the development of equipment operational procedures.
• Support equipment validation activities and execute equipment qualification and validation protocols.
• Develop validation and qualification deliverables, including Validation Plans, Requirements Specifications, Design Specifications, Traceability Matrices, and Summary Reports.
• Support the Change Management process.
• Support equipment implementation projects, including scheduling, site preparation, installation, qualification, and turnover to business.
• Support operation, calibration, and preventive maintenance of equipment to meet business requirements.
• Complete qualification and validation documentation accurately and in compliance with client standards.
• Review, prioritize, and respond to customer equipment qualification and support requests.
• Provide technical support and guidance on equipment qualification issues.
• Interface with customers to ensure expectations are met.
• Provide technical support for equipment, utilities, facilities, and computerized systems qualification and validation issues.
• Maintain positive working relationships with team members and site customers.
• Ensure equipment, facilities, and programs remain compliant with regulatory requirements.
• Participate in deviation investigations as a Subject Matter Expert (SME), when required.

Education & Experience:

• BS in Engineering or Science related discipline preferred; equivalent relevant experience may be considered.
• Minimum of 5 years of experience performing or supporting activities in a GMP environment.
• Minimum of 3 years of experience in equipment, facilities, or utilities qualification.
• Knowledge of cGMP, GxP, GAMP, SDLC, 21 CFR Part 11, Computer System Validation (CSV) requirements, and Good Documentation Practices.
• Knowledge of pharmaceutical manufacturing and laboratory systems.
• Understanding of investigations, deviations, and CAPA management in a regulated pharmaceutical environment.
• Strong written, verbal, interpersonal, organizational, and multitasking skills.
• Detail-oriented with a strong commitment to quality, safety, and compliance.
• Ability to manage multiple projects and prioritize tasks effectively.
• Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and database systems.
• Experience with Electronic Data Management Systems such as ValGenesis is preferred.