Junior 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

We are seeking a Junior Qualification & Decommissioning Specialist to support pharmaceutical manufacturing facility projects involving equipment qualification, system decommissioning, and documentation management activities. This position is ideal for candidates with 2 to 4 years of experience in regulated GMP environments who possess strong technical writing, documentation, and project coordination skills.

The successful candidate will support the assessment, planning, documentation, execution, and closeout of decommissioning activities for manufacturing equipment, utilities, and facility systems. This role requires the ability to work independently, collaborate with cross-functional teams, and deliver quality project documentation within aggressive project timelines.

Key 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.

Documentation Management

• Manage the preparation, routing, review, approval, and archival of project documentation using electronic document management systems.
• Maintain documentation within systems such as:
• Kneat
• TrackWise
• Other approved quality management systems
• Ensure documentation complies with internal procedures and regulatory requirements.

Project Coordination

• Coordinate activities with Engineering, Validation, Manufacturing, Quality Assurance, Facilities, and Subject Matter Experts.
• Attend project meetings, validation review boards, planning sessions, and other project-related meetings as required.
• Communicate project status, risks, concerns, and schedule impacts to project leadership.
• Support the successful achievement of project milestones and deliverables.

Reporting

• Prepare and submit weekly activity reports including:
• Planned versus completed activities
• Risks and roadblocks
• Recommended actions
• Billable hours and resource utilization

Required 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.

Preferred Qualifications

• Experience in equipment decommissioning within pharmaceutical or biotechnology facilities.
• Experience with electronic validation and quality systems such as Kneat, Veeva Vault, TrackWise, OneVault, or similar systems.
• Familiarity with:
• Change control processes
• Deviations and CAPA systems
• Facility and utility validation
• Good Documentation Practices (GDP)
• Pharmaceutical and biotechnology manufacturing facilities
• GMP-regulated production environments
• Office and manufacturing floor support activities
• Up to 40 hours per week based on project needs
• Potential for occasional travel depending on project location and assignments

About Trinity Consultants

Trinity Consultants is a leading provider of environmental, health, safety, engineering, quality, and life sciences consulting services. Our professionals partner with clients in highly regulated industries to deliver compliance solutions, technical expertise, operational excellence, and project execution support. We are committed to helping our clients successfully navigate complex regulatory and operational challenges while advancing safety, quality, and business performance.

Trinity Consultants is an Equal Opportunity Employer committed to fostering an inclusive and diverse workplace.