Clean Utilities Technical Project Manager

Quanta Consultancy Services Ltd; North Carolina; On-site; USD 90,000 - 130,000; Full time

Job summary

A leading biotechnology firm in North Carolina seeks a Clean Utilities Technical Project Manager for a new biomanufacturing plant project. This role involves managing the lifecycle of clean utilities equipment, ensuring compliance with quality standards and regulatory requirements. Candidates should have a solid background in process engineering, with specific experience in drug substance biologics projects. This is an excellent opportunity to contribute to impactful health solutions.

Qualifications

• 5-8 years of experience in process engineering, CQV, or project management.
• In-depth knowledge of clean utilities processes.
• Familiarity with GMP regulations and safety standards.

Responsibilities

• Lead clean utilities equipment lifecycle for biomanufacturing plant.
• Serve as technical SME in clean utilities processes and equipment.
• Coordinate Factory and Site Acceptance Tests for equipment.

Skills

Problem-solving

Communication

Team collaboration

Education

Bachelor’s degree in Chemical Engineering

Bachelor’s degree in Biochemical Engineering

Job description

Clean Utilities Technical Project Manager - US, North Carolina - 12 Month Contract

Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Clean Utilities Technical Project Manager. A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to stride for solutions. This is your chance to join them on their global mission to better the lives of those effected by disease and illness. The project at hand is for the construction of a new build biomanufacturing plant based located on the East Coast.

Essential duties and responsibilities for this role include, but are not limited to, the following:

• Lead and manage the full clean utilities 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 clean utilities 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 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 5-8 years of experience and a solid background may also be considered.
• In-depth knowledge of clean utilitiesprocesses.
• 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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