Manufacturing Engineer (Biologics / Large Molecule)

ZipRecruiter; Winterville (NC); Hybrid; USD 80,000 - 120,000; Full time

Job summary

Une entreprise dynamique recrute pour un poste d'ingénieur de fabrication (Biologics / Large Molecule) pour un projet de construction d'une nouvelle installation. Ce rôle crucial implique la gestion du design à la construction tout en garantissant la conformité aux normes GMP. Si vous êtes un ingénieur expérimenté cherchant à jouer un rôle clé dans une équipe dédiée à l'innovation, nous voulons vous rencontrer.

Qualifications

• Minimum de 5 ans d'expérience en ingénierie de processus dans des installations GMP de molécules larges.
• Expérience en supervision des fournisseurs d'équipement et des entreprises d'architecture et d'ingénierie.
• Expertise technique avec des équipements de fabrication d'anticorps monoclonaux à grande échelle.

Responsibilities

• Gérer l'interaction avec les fournisseurs d'équipement et les gestionnaires de construction pour assurer la livraison des projets.
• Responsable de la portée, du coût et de la livraison à temps des équipements de processus.
• Participer aux revues de modèles 3D pour confirmer l'opérabilité et la maintenabilité des équipements.

Skills

Process Engineering

GMP Knowledge

Project Management

Technical Expertise in Biologics

Collaboration

Problem Solving

Education

Bachelor's Degree in Chemical or Mechanical Engineering

Job description

POSITION: Manufacturing Engineer (Biologics / Large Molecule)

POSTING: 69668 / JNJNJP00069668

LOCATION: Client Site, Wilson NC* (Greenfield Site in Wilson NC, Travel to Conshohocken PA Engineering Office is reimbursed.)

Mason-Grey is hiring a Manufacturing Engineer (Level II to Level III) for an exciting multi-year greenfield biologic plant engineering project. If you have experience in engineering and designing bioprocess equipment (reactors, piping systems, skids, automation), we want to connect! Be on the cutting edge of Life Science processes and join our team and play a pivotal role in the design and development of a new plant. This is a long term contract opportunity supporting the engineering, design and development of the new process plant.

* 3 days in office, 2 days remote transitioning to onsite in late 2025 or early 2026.

Principal Process Engineer

The primary location for this role is Wilson, NC. Design is taking place in Conshohocken, PA. The design phase requires a hybrid work location of remote and onsite in Wilson, as well as routine travel to Conshohocken. Once the design phase is completed, this role will support the construction and operational start-up of the site. For this, you will be required to be on site full-time in Wilson, NC.

Position summary:

This role reports to a System Owner – Area Lead within the System Owner team. The System Owners will be assigned several pieces of equipment and areas within the production building scope. The main role for the System Owner (Engineering SME) is to act as project manager and technical subject matter expert for their systems for the duration of the project from design to construction, until commissioning and qualification is completed.

This is intended to be a general job description and should not be construed as all-inclusive.

Key Responsibilities:

• Extensive interaction with A&E firm, equipment vendors, automation vendors and construction manager to develop, organize and execute project plans.
• Accountable for scope, cost and on-time delivery of process equipment from design to start-up.
• Collaborating closely with system user, project engineering, construction management, PMO, C&Q and automation to ensure the user requirements are met through all phases of the project.
• Addresses any conflicts in design, construction or at the field and elevate any issues that require management input.
• Responsible for verifying that the requirements of the URS are incorporated into the design.
• Participates in 3D model reviews to confirm operability and maintainability of equipment.
• Manages FAT & SAT including review and approval of protocols, planning vendor visits, and overseeing execution and resolution of punch-list items.
• Ensures that all EHS-by-design (EBD) requirements are incorporated in the equipment bidding (front-end definition), purchase packages and design documents.
• Attends the system walk downs during construction and organizes the owner side of the walk down.
• Approves the System Commissioning Test Plans (CTP) pre and post execution.
• Reviews (technical accuracy and acceptability of complete system) Engineering Turnover Package to ensure they are in accordance with Engineer / Manufacturer / User Specifications and Drawings.
• Assists in the turnover of the documentation for their system to the owner document control system.
• The incumbent should demonstrate the following: sense of urgency, detail and goal oriented, teamwork, customer-focus, thorough understanding of GMPs and regulatory requirements.

Education:

• Minimum of a Bachelor's or equivalent University Degree required in chemical or mechanical engineering

Experience and Skills:

• A minimum of five (5) years of process/plant engineering experience in GMP MFG large molecule biologics facilities.
• Experience overseeing process equipment vendors and A&E firms project delivery is required.
• Experience and technical expertise with large scale monoclonal antibody manufacturing equipment is required. Technical expertise in centrifuges, depth filtration, single-use solution prep and storage, and closed filling systems is essential.
• Experience in green or brown field GMP manufacturing facility start-up including process systems, automation, utilities, facilities, C&Q, and operations is required.
• Strong technical background in Process and Manufacturing engineering.
• The ability to lead and/or support multiple projects simultaneously.
• Engineers new and modifies existing processes to ensure right first-time process start up.
• Experience with review and approval of different engineering documents and drawings.
• Ability to travel and lead Factory Acceptance Tests of process equipment.

Other:

• This position may require domestic or international travel based on project business needs.
• Routine travel to Conshohocken, PA required through the end of the detailed design phase.
• Travel to equipment vendor locations required through the end of equipment delivery.
• Full-time onsite work in Wilson, NC required during construction and start-up phase.

All candidates shall be legally authorized to work in the US and are subject to background screening, drug testing and verification of legal status in the United States using eVerify.

Company Description: The Mason-Grey Corporation provides engineering solutions and services to process industry clients in energy, metals, plastics, biotech, pharmaceutical, and other key process markets. Today Mason-Grey executes projects and provides services to the Fortune 500 and mid-tier companies from coast to coast. Mason-Grey employees live and work in support of our mission from Massachusetts to California. Mason-Grey is headquartered in Atlanta, Georgia.