Commissioning Engineer
ALLIANCE BIOTECH SOLUTIONS LLC
Description:
The Automation Commissioning Engineer is responsible for leading the commissioning, startup, troubleshooting, and turnover of GMP automation systems supporting pharmaceutical manufacturing operations. This role serves as the technical lead for automation commissioning activities, working closely with system integrators, engineering, validation, quality, IT/OT, and equipment vendors to ensure automation systems are safely commissioned, fully functional, and ready for qualification and manufacturing. The successful candidate will drive execution of the commissioning plan, resolve field issues, and support the transition from construction through operational readiness.
Requirements:Lead commissioning and startup activities for Process Control Systems (PCS), Environmental Monitoring Systems (EMS), and Manufacturing Execution Systems (MES).
Execute loop checks, I/O verification, functional testing, alarm testing, interlock verification, and integrated system testing.
Coordinate daily commissioning activities with automation integrators, vendors, construction, validation, quality, manufacturing, and IT/OT teams.
Troubleshoot automation hardware, software, communications, and system integration issues during startup and commissioning.
Verify installation and operation of PLCs, DCS, SCADA/HMI systems, field instrumentation, control panels, and network infrastructure.
Develop and maintain commissioning documentation, turnover packages, punch lists, commissioning reports, and issue logs.
Support FAT, SAT, system turnover, and the successful transition into qualification and manufacturing operations.
Experience/Skills
5+ years of automation, commissioning, CQV, or controls engineering experience in pharmaceutical, biotechnology, or life sciences manufacturing.
Experience commissioning GMP manufacturing equipment and automation systems.
Strong knowledge of PLCs, DCS, SCADA, HMI, and industrial automation platforms.
Experience performing loop checks, I/O verification, functional testing, and startup activities.
Ability to read and interpret P&IDs, electrical drawings, control narratives, instrument datasheets, and network diagrams.
Familiarity with cGMP, FDA regulations, ISPE guidance, and GAMP 5 principles.
Benefits & Compensation
Industry competitive wage as a full-time employee
20 days Flexible Paid Time Off
Medical, Dental and Vision Insurance with low employee cost
Employer paid long term and short-term disability
401k plan with employer contributions
About Alliance Biotech Solutions
Alliance Biotech Solutions (ABS) is a premier consulting firm specializing in biopharmaceutical engineering and validation services. As industry leaders in Commissioning, Qualification, and Validation (CQV), we provide crucial services to the biotech and pharmaceutical sectors while maintaining our philosophy that employees are our #1 priority. Our success is built on the foundation of empowering our team members' growth and development, recognizing that our employees are the cornerstone of our clients' success.
Alliance Biotech Solutions is an Equal Employment Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, ancestry, citizenship status, military status, protected veteran status, religion, creed, physical or mental disability, medical condition, marital status, sex, sexual orientation, gender, gender identity or expression, age, genetic information, or any other basis protected by law, ordinance, or regulation.
Alliance Biotech Solutions does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Alliance Biotech Solutions, and Alliance Biotech Solutions will not be obligated to pay a placement fee.
All persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire.
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