Quanta Consultancy Services Ltd
Cold Room Package Owner
Quanta Consultancy Services Ltd, Raleigh, North Carolina, United States
Overview
Cold Room Package Owner - US, North Carolina - 12 Month Contract
Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of a Cold Room Package Owner. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness. The project at hand involves the construction of a new biomanufacturing plant on the East Coast.
Responsibilities Essential duties and responsibilities for this role include, but are not limited to, the following:
Lead and manage the full cold room equipment lifecycle and engineering scope for greenfield drug substance manufacturing lines.
Work closely with cross-functional teams, including design, equipment, and construction, to ensure timely and effective execution.
Act as the technical Subject Matter Expert (SME) in cold room processes and equipment.
Oversee the design and specifications of process equipment, ensuring they meet project requirements.
Coordinate Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for equipment.
Provide technical support and expertise throughout the project lifecycle, from design to start-up and handover.
Review and recommend improvements to processes and procedures to ensure optimal efficiency and compliance with industry standards.
Ensure the integration of process systems and equipment aligns with the client's quality standards and regulatory requirements.
Support commissioning and qualification efforts for process equipment.
Desirable Experience
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related discipline.
Extensive experience in process engineering, CQV, or project management, with a strong focus on drug substance biologics projects. Candidates with strong experience and a solid background may also be considered.
In-depth knowledge of cold room processes.
Proven experience in the design, specification, SATs, and FATs for process equipment.
Strong technical expertise in drug substance equipment.
Familiarity with GMP regulations, safety standards, and industry best practices.
Excellent problem-solving, communication, and team collaboration skills.
If this role is of interest, please apply now.
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Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of a Cold Room Package Owner. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions. This is your chance to join them on their global mission to better the lives of those affected by disease and illness. The project at hand involves the construction of a new biomanufacturing plant on the East Coast.
Responsibilities Essential duties and responsibilities for this role include, but are not limited to, the following:
Lead and manage the full cold room equipment lifecycle and engineering scope for greenfield drug substance manufacturing lines.
Work closely with cross-functional teams, including design, equipment, and construction, to ensure timely and effective execution.
Act as the technical Subject Matter Expert (SME) in cold room processes and equipment.
Oversee the design and specifications of process equipment, ensuring they meet project requirements.
Coordinate Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) for equipment.
Provide technical support and expertise throughout the project lifecycle, from design to start-up and handover.
Review and recommend improvements to processes and procedures to ensure optimal efficiency and compliance with industry standards.
Ensure the integration of process systems and equipment aligns with the client's quality standards and regulatory requirements.
Support commissioning and qualification efforts for process equipment.
Desirable Experience
Bachelor’s degree in Chemical Engineering, Biochemical Engineering, or related discipline.
Extensive experience in process engineering, CQV, or project management, with a strong focus on drug substance biologics projects. Candidates with strong experience and a solid background may also be considered.
In-depth knowledge of cold room processes.
Proven experience in the design, specification, SATs, and FATs for process equipment.
Strong technical expertise in drug substance equipment.
Familiarity with GMP regulations, safety standards, and industry best practices.
Excellent problem-solving, communication, and team collaboration skills.
If this role is of interest, please apply now.
#LI-DA1
#J-18808-Ljbffr