Commissioning Qualification Technical Lead (Pharmaceutical Industry)

ertus is a global capital program management and advisory firm that combines deep human expertise with advanced digital tools to deliver smarter, faster, and more sustainable outcomes. Headquartered in Miami, Florida, and supported by a team of more than 1,000 professionals worldwide, we help clients plan, execute, and optimize large-scale capital programs.

Our integrated services span digital, advisory, and delivery, empowering organizations to navigate complexity, manage risk, and achieve strategic goals in sectors including aviation, transportation, transit, water, healthcare, energy, education, government, commercial, life sciences, and technology.

At Consertus, we celebrate individual strengths, foster strong relationships, and promote flexibility in how and where we work. Join us to grow your career, develop your skills, and make a lasting impact as we transform how the world is built.

Discover how Consertus is driving transformative change for our clients, our people, and the communities we serve at www.consertus.com

About this Role:

We are seeking a highly skilled and experienced Commissioning Qualification Technical Lead to oversee and coordinate the validation activities within pharmaceutical manufacturing facilities. This pivotal role involves leading the commissioning and qualification processes of complex systems and equipment, ensuring compliance with regulatory standards such as GMP (Good Manufacturing Practice) and industry best practices. The ideal candidate will possess a strong technical background, including expertise in quantum engineering, to facilitate seamless integration and validation of advanced pharmaceutical technologies. You will play a critical role in ensuring that manufacturing systems meet all quality, safety, and operational requirements before full-scale production.

Key Responsibilities:

• Collaborate with the Construction Project Manager to coordinate all stages of construction
• Serve as liaison between contractors, clients, and internal teams to ensure seamless project communication
• Track project milestones and provide detailed progress reports
• Perform regular site visits to evaluate project status, safety, and compliance
• Uphold strict adherence to deadlines and quality standards for all deliverables

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical, Industrial), Biotechnology, or related technical field.

• 5+ years of experience in commissioning, qualification, or validation within pharmaceutical, biotech, or medical device industries.

• Strong knowledge of cGMP, GEP, GAMP 5, and regulatory expectations for equipment and facility qualification.

• Hands‑on experience with utilities (HVAC, WFI, clean steam, compressed air), process equipment, and/or automation systems.

• Demonstrated ability to lead cross‑functional teams and manage multiple CQ workstreams.

• Strong technical writing, documentation, and problem‑solving skills.

• Proficiency with CQ project tools, quality systems, and change control processes.

Preferred Qualifications

• Experience with aseptic/sterile manufacturing systems or biologics equipment.

• Familiarity with automation platforms (DeltaV, PLCs, SCADA) and data integrity requirements.

• Experience supporting FAT/SAT execution at vendor sites.

• CQV or validation‑related certifications.

• Bilingual (English/Spanish) communication skills.

Core Competencies

• Technical Leadership — Guides CQ strategy and ensures technical accuracy across all deliverables.

• Compliance Mindset — Maintains rigorous documentation and audit readiness.

• Cross‑Functional Collaboration — Works effectively with engineering, QA, operations, and vendors.

• Analytical Thinking — Interprets data, identifies risks, and drives resolution.

• Execution Discipline — Manages timelines, priorities, and project milestones with precision.

Why Join Us:

• Paid time off, including vacation, sick leave and holidays
• Medical, Dental and Vision Insurance
• Retirement Savings Plan with company match and day-one eligibility
• Company-paid disability insurance
• Access to Consertus Academy for continuous learning and development

Equal Employment Opportunity Statement:

Consertus is proud to be an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We welcome applicants from all backgrounds and identities, and we do not discriminate based on race, color, religion, sex, sexual orientation, gender identity or expression, national origin, disability, age, veteran status, or any other protected status.

Job Type: Full-time

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Work Location: In person