MECHANICAL TECHNICIANS
Descrizione dell'offerta di lavoro
They are making an investment of more than $2 Billion USD to establish a new large-scale cell culture production site in the United States to accelerate the growth of its biopharmaceutical contract development and manufacturing business.
With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.
Main Responsibilities; Perform mechanical commissioning activities for new or modified systems, ensuring compliance with specifications and regulatory requirements.
Conduct qualification of mechanical systems, including HVAC, plumbing, steam, compressed air, and other critical mechanical utilities.
Verify proper installation and functionality of mechanical equipment and systems according to project and design specifications.
Review and execute qualification protocols, including IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) for mechanical systems.
Develop, review, and execute mechanical testing protocols (such as pressure testing, leak testing, system balancing, etc.).
Prepare and maintain detailed commissioning and qualification documentation, including test records, deviation reports, and final qualification reports.
Ensure all mechanical system activities are documented and compliant with Good Manufacturing Practices (GMP) or other relevant regulatory standards.
Requirements; Minimum of 3–5 years of experience in mechanical commissioning, qualification, or validation within regulated industries (pharmaceutical, biotech, or similar) Perform mechanical commissioning activities for new or modified systems, ensuring compliance with specifications and regulatory requirements.
Conduct qualification of mechanical systems, including HVAC, plumbing, steam, compressed air, and other critical mechanical utilities.
If this role is of interest to you, please apply now! #LI-MC1
Dettagli dell'offerta
- QCS Staffing
- Tutta l'Italia
- Imprecisato - Imprecisato
- Imprecisato
- 20/11/2024
- 18/02/2025
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