QCS Staffing
Harvest Systems Technical Project Manager
QCS Staffing, Raleigh, North Carolina, United States
Overview
Harvest Systems Technical Project Manager - US, North Carolina - 12 Month Contract. Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of Harvest Systems Technical Project Manager. This project involves the construction of a new build biomanufacturing plant based on the East Coast. Responsibilities
Lead and manage the full harvesting system 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 harvesting 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 / Qualifications
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 harvest systems and 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. Employment details
Seniority level: Mid-Senior level Employment type: Contract Job function: Project Management and Information Technology Note: This description preserves the core responsibilities and qualifications from the original posting while removing extraneous boilerplate and non-relevant details.
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Harvest Systems Technical Project Manager - US, North Carolina - 12 Month Contract. Our client, a globally recognized pioneer in Biotechnology, is recruiting for the position of Harvest Systems Technical Project Manager. This project involves the construction of a new build biomanufacturing plant based on the East Coast. Responsibilities
Lead and manage the full harvesting system 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 harvesting 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 / Qualifications
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 harvest systems and 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. Employment details
Seniority level: Mid-Senior level Employment type: Contract Job function: Project Management and Information Technology Note: This description preserves the core responsibilities and qualifications from the original posting while removing extraneous boilerplate and non-relevant details.
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