Downstream Technical Package Owner

QCS Staffing; North Carolina; On-site; USD 140,000 - 190,000; Full time

Job summary

A leading biotechnology firm is seeking a Downstream Technical Package Owner in North Carolina for a 12-month contract. The role involves managing the full downstream equipment lifecycle for a new biomanufacturing plant and acting as a Subject Matter Expert in downstream processes. Ideal candidates will have a background in Chemical or Biochemical Engineering and extensive experience in drug substance biologics projects.

Qualifications

• Bachelor's degree in Chemical Engineering, Biochemical Engineering, or related discipline.
• Extensive experience in process engineering, CQV, or project management, strong focus on drug substance biologics projects.
• In-depth knowledge of downstream manufacturing 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.

Responsibilities

• Lead and manage the full downstream equipment lifecycle and engineering scope for greenfield drug substance manufacturing lines.
• Work closely with cross-functional teams to ensure timely and effective execution.
• Act as the technical Subject Matter Expert in downstream processes.
• Oversee the design and specifications of process equipment.
• Coordinate Factory Acceptance Tests and Site Acceptance Tests for equipment.
• Provide technical support throughout the project lifecycle.
• Review and recommend improvements to processes and procedures.
• Ensure integration of process systems aligns with quality standards.
• Support commissioning and qualification efforts for process equipment.

Skills

Problem-solving

Communication

Team collaboration

Education

Chemical Engineering

Job description

Overview

Downstream Technical Package Owner - US, North Carolina - 12 Month Contract

Our client, a globally recognized pioneer in Biotechnology, are recruiting for the position of Downstream Technical Package Owner. 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.

Responsibilities

• Lead and manage the full downstream 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 downstream processes.
• 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.
• Requires 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 downstream manufacturing 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.

How to apply

If this role is of interest, please apply now.