Emerging Qualification & Decommissioning Specialist

Trinity Consultants Engineering & EHS Workforce Solutions; Chicago (IL); On-site; USD 60,000 - 90,000; Full time

Job summary

Trinity Consultants Engineering & EHS Workforce Solutions seeks a Junior Qualification & Decommissioning Specialist to support pharma manufacturing projects involving equipment qualification, system decommissioning, and documentation management.

The role targets candidates with 2–4 years in regulated GMP environments, skilled in technical writing, documentation, and cross-functional project coordination. Strong collaboration with engineering, validation, QA, and facilities is essential.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, Biotechnology, Pharmaceutical Sciences, or a related technical discipline.
• 2 to 4 years of experience in pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience supporting qualification, validation, commissioning, or decommissioning activities.
• Familiarity with cGMP regulations and validation lifecycle requirements.
• Strong technical writing and documentation management skills.
• Ability to work effectively both independently and within cross-functional teams.
• Strong organizational, analytical, and problem-solving abilities.
• Excellent verbal and written communication skills.

Responsibilities

• Support qualification and decommissioning activities for pharmaceutical manufacturing equipment, utilities, and facility systems.
• Assess assets scheduled for decommissioning and determine the appropriate change control pathway in accordance with site and global procedures.
• Author decommissioning protocols, reports, engineering change documentation, and related validation deliverables.
• Execute approved decommissioning protocols and document project activities.
• Support issue investigation, deviation management, and resolution activities.
• Ensure documentation is completed accurately, thoroughly, and in accordance with GMP requirements.
• Participate in project turnover and closure activities.

Skills

Technical writing

Documentation management

Project coordination

Communication

Education

Bachelor's degree in Engineering or related technical discipline

Tools

Kneat

TrackWise

Veeva Vault

OneVault

Job description

Trinity Consultants Engineering & EHS Workforce Solutions seeks a Junior Qualification & Decommissioning Specialist to support pharma manufacturing projects involving equipment qualification, system decommissioning, and documentation management.

The role targets candidates with 2–4 years in regulated GMP environments, skilled in technical writing, documentation, and cross-functional project coordination. Strong collaboration with engineering, validation, QA, and facilities is essential.