View all jobs
Sr Commissioning Specialist
mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.
Position Summary
We are seeking a highly experienced Senior Commissioning Specialist to support the installation and commissioning of a new GMP autoclave and associated facility upgrades within a pharmaceutical manufacturing environment. This role will lead and coordinate commissioning activities for equipment, utilities, HVAC, automation, and facility systems to ensure successful startup, qualification readiness, and operational handover.
Key Responsibilities
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.
Position Summary
We are seeking a highly experienced Senior Commissioning Specialist to support the installation and commissioning of a new GMP autoclave and associated facility upgrades within a pharmaceutical manufacturing environment. This role will lead and coordinate commissioning activities for equipment, utilities, HVAC, automation, and facility systems to ensure successful startup, qualification readiness, and operational handover.
Key Responsibilities
- Plan, coordinate, and execute commissioning activities throughout the project lifecycle.
- Develop and maintain commissioning documentation, schedules, status reports, and turnover packages.
- Support design reviews, system boundary definition, commissioning planning, and startup readiness activities.
- Coordinate field execution with contractors, vendors, and cross-functional teams.
- Perform installation verification, field inspections, quality assessments, and deficiency tracking.
- Support startup activities, functional testing, integrated system testing, and operational readiness assessments.
- Facilitate construction turnover, system acceptance, and handover to Operations and Maintenance.
- Ensure commissioning records and deliverables are completed, approved, and properly maintained.
- Support qualification and validation readiness in compliance with GMP requirements.
- Bachelor's degree in Engineering or related technical field preferred.
- More than 5 years of experience in Facilities and Utilities Commissioning within the pharmaceutical or regulated manufacturing industry.
- Experience supporting commissioning activities in sterile manufacturing or packaging environments.
- Strong knowledge of cGMP regulations and commissioning best practices.
- Experience with:
- Clean Utilities Systems
- HVAC Commissioning
- Building Automation Systems (BAS), preferably Honeywell platforms
- Construction Turnover and System Handover
- Startup and Operational Readiness Programs
- Automation and integrated facility systems
- Digital validation platforms and electronic lifecycle management tools
- Commissioning, startup, and qualification support of process, utility, facility, and automation systems.
- Knowledge of utility systems including clean steam, compressed air, water systems, instrumentation, and electrical infrastructure.
- Experience reviewing technical documentation, test protocols, commissioning plans, and turnover packages.
- Proficiency in Microsoft Office applications.
- Strong technical writing and documentation skills.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.