Validation Engineer

ACL Digital; New Albany (OH); On-site; USD 70,000 - 110,000; Full time

Job summary

ACL Digital seeks a Commissioning and Qualification Specialist to lead and execute C&Q activities for GMP analytical and process equipment, utilities, and facilities. You will develop test strategies, review protocols, and coordinate with project teams to ensure compliant, timely delivery.

The role requires strong knowledge of cGMP practices, experience with digital C&Q systems, and excellent communication. You will manage multiple projects, resolve issues, and report progress to stakeholders.

Qualifications

• Experience in pharmaceutical/life sciences C&Q/CQV role in GMP
• Knowledge of cGMP commissioning/qualification/validation practices
• Familiarity with Kneat Gx Platform or other digital C&Q systems
• Experience working with cross-functional stakeholders
• Knowledge of quality assurance principles
• Experience working within project teams and multiple projects in parallel
• Effective communication skills, both verbal and written
• Able to think analytically with the ability to resolve issues
• Able to manage own time efficiently

Responsibilities

• Lead and execute commissioning and qualification activities on GMP analytical and process equipment, utilities, and facilities.
• Develop and review C&Q protocols, plans, and summary reports; coordinate with project teams and SMEs.
• Participate in project meetings to inform stakeholders on progress of C&Q activities.

Skills

GxP C&Q experience

cGMP knowledge

Cross-functional collaboration

Analytical thinking

Time management

Verbal & written communication

Project multitasking

Kneat Gx platform

Tools

Kneat Gx

Job description

Primarily responsible for leading and/or executing commissioning and qualification activities on new or modified GMP analytical and process equipment, utilities, and facilities. Responsibilities include generating/reviewing/executing C&Q protocols, plans, and summary reports. Works with project teams and SMEs to develop testing strategies. Participates in project meetings to inform stakeholders on progress of C&Q activities.

Key Skills and Requirements

• Demonstrable experience in a pharmaceutical, biotech, or life science organization in a C&Q/CQV role.
• Knowledge of cGMP commissioning/qualification/validation practices.
• Familiarity with Kneat Gx Platform or other digital C&Q systems.
• Experience working with cross-functional stakeholders.
• Knowledge of quality assurance principles.
• Experience working within project teams and multiple projects in parallel.
• Effective communication skills, both verbal and written.
• Able to think analytically with the ability to resolve issues.
• Able to manage own time efficiently.

Top 3 Must Have Skill Sets

Experience in commissioning/qualification/validation, experience in a GMP environment, experience with analytical instruments (Benchtop laboratory equipment)