Process / Project Engineer Specialist - Drug Substance Facility Scale Up

The Spear Group Full-Time Positions with Corporate Benefits

Title:

Process / Project Engineer Specialist – Drug Substance Facility and Scale Up

Chemical Engineer, Mechanical Engineer, Biomedical, Biomolecular processing Engineer, or related Biopharma Engineering Degree

Location: Carteret, NJ

Position Summary:

The Spear Group has multiple openings for qualified biopharma process and project engineer specialists to support our top-tier biopharma client with bioprocessing capital projects: 1) drug substance manufacturing process development and 2) bioprocessing facility scale up.

Responsibilities can involve exposure to a wide range of biopharma manufacturing operations and capital project areas: Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation.

These engineering specialist positions will be part of a high performing team, accountable for implementation of projects that assist a growing portfolio of small molecule related work. The Process Engineer or Project Engineer Specialist brings forward strong subject matter expertise to lead studies and evaluations, determine suitability, establish direction, conduct risk assessments, define safeguards, assess operability, interface with vendors, construction, commissioning as well as operational readiness.

This position can have responsibilities related to the planning, design, and implementation of engineering solutions on a process / project team within a large capital project. Core work can involve equip/scope generation, process & facility design, equipment selection, vendor interaction/management, factory acceptance testing, technology transfer support, construction support, equipment qualification, facility start-up and knowledge transfer.

Candidates with significant experience involving (Drug Substance, Drug Product, Plant and Clean utilities), product equipment operation, vendor management, process safety and industry guidance are preferred. Candidate should have demonstrated ability to be part of a cross functional team through drug substance facility and process development project during design and execution, while championing innovative solutions that meet the objectives of the business. The candidate should have a strong understanding of the drug substance line of business, understand lean design and delivery, implement standard work and be able to drive technical areas and small capital projects (process & facility) from an end-to-end perspective.

Key Responsibilities:

• Provide process and project engineering support as needed for bioprocessing related activities and capital projects driving innovation and efficiency in execution of project deliverables - small molecule drug substance facilities and manufacturing processes.
• Guide or assist project design and development efforts.
• Participate in engineering design & planning review sessions.
• Work with team in the evaluation and evolution of alternative solutions and the development of project scope.
• Ensure that deliverables conform to the organizations standards and practices and are technically sound.
• Provide technical guidance during project implementation, assure viability of technology in proposed configuration.
• Liaise with other technical functions to ensure successful technology transfers of new and existing products.
• Work with contractors, suppliers, and other team members in the execution of the work.

Required & Preferred Experience and Education:

• BS Degree in Engineering – Chemical, Mechanical, Bioprocessing, Biomedical, Biologics, Biotechnology.
• 1-15 years of experience in a pharmaceutical engineering role, such as Process/Equipment Engineering Design, Technical Operations, Single Use Technology, or Sterile Operations/Facilities.

• Minimum two (2) years of experience with bioprocessing capital equipment life cycle approach including specification, selection, testing & commissioning, troubleshooting, or qualification.
• Strong project and time management skills to facilitate on-time delivery and quality work
• Experience representing Engineering project interests on Project Teams for drug substance and drug product Small Molecule projects for laboratories, pilot plants, or production facilities for both new construction and/or renovations.
• Ability to work independently and meet timelines in a fast-paced team environment.
• Strong self-motivation; proactive, high-energy, "can do" work ethic; ability to handle potentially stressful situations with a positive attitude.
• Ability to foster collaboration and consensus building among colleagues in a world class biopharma workplace.
• Process leadership experience in pilot plants, or manufacturing capital projects

• Process design experience on large capital projects that follow a stage-gate process
• Strong understanding of containment philosophies for potent compounds
• Experience with Process Safety Management, Industrial Hygiene/Potent Compounds and Ergonomic Risk Assessment for capital projects

Compensation based of relevant experience

EQUAL OPPORTUNITY EMPLOYER

The Spear Group, Inc. is an Equal Opportunity Employers. All personnel actions are affected without regard to race, color, sex, age, religion, national origin, disability, veteran status, or other protected status pursuant to law. As a responsible organization, we resolutely support the concept and practice of Equal Employment Opportunity. We uphold federal, state, and local civil rights laws and work to ensure that all of our personnel actions and policies are in compliance. Additionally, we recognize and value the importance and diversity of our work force and support its various cultures. The Companies are dedicated to fostering an environment that respects the dignity, rights and contributions of our employees.