Process Engineer Downstream Operations

AM Technical Solutions- Who Are We:

AM Technical Solutions (AM), founded in 1994, is a proven and licensed architecture, engineering, and construction firm bringing innovative solutions to the Biopharma industry to help in the fight to save lives. Our knowledge and expertise in high-tech spaces combined with our culture-first mentality allows our team to deliver the entire scope of work for high-tech construction projects on schedule, on budget, and at the level of quality required by customers. AM Life Science being an integrated part of AM Technical Solutions brings new energy and ideas to an ever-changing industry. Our team is comprised of motivated, intelligent, capable and qualified individuals who design, execute and manage projects and programs that implement risk-based approaches utilizing scientific data and justifications to align with the regulatory and industry standards. AM Life Science takes pride in our accuracy, efficiency, and integrity, which translates into cost and time savings for our Clients.

Job Title:

Process Engineer- Downstream Operations

Current Locations:

Massachusetts

Position Description

Operational support of the biologics manufacturing process for commercial and clinical products. Responsible for technical support of the startup, commissioning and qualification of a manufacturing facility, sustaining operations, troubleshooting, root cause analysis, and process optimization within multi-product, FDA-regulated cGMP facilities.

This position will allow for fluid interaction between multiple departments, including Manufacturing, Facilities, Quality Assurance, Validation, Regulatory to facilitate closure of task items, and completion of projects. May be involved in vendor management, equipment, and facility design, including Conceptual Design, Basis of Design, and Detailed Design, including equipment specification, procurement, construction, and commissioning of process equipment for cGMP production facilities. May be involved in technology transfers, including feasibility studies, facility fit assessment, generation of user requirements, process description, change control ownership, commissioning test plans, training of Site Engineers and Manufacturing personnel, as well as startup, commissioning, validation, and operational support.

Responsibilities

Operational Support

• Troubleshooting of Downstream Manufacturing process equipment, as well as evaluation of process anomalies.
• Understanding of industry-standard Single Use Technology (SUT)
• Serve as a responsible engineer for cleaning (CIP/COP), sanitization/sterilization, process analytics, and bench-scale instruments.
• Implementation and assessment of single-use technology.
• Serve as facilitator for correction and closeout of action items in Quality Systems, such as TrackWise.

Small Project Owner

• Manage small projects to ensure quality, functionality, cost, and schedule.
• Accountable for all aspects of the Change Control process for implemented changes.
• Facilitate timely closure of equipment-related CAPAs.
• Generation of supporting life cycle documentation (URSs, work orders, test protocols, P&IDs, and commissioning test plans.).
• Investigate and define all aspects of the individual project scope.
• Provide Engineering review for Quality Engineering documentation.

Large Project Support

• Work with the project team to generate engineering design requirements.
• Develop and support any feasibility studies or engineering tests required to define project scope.
• Coordinate with vendors to obtain proposals for equipment and support utility changes.
• Develop and execute engineering tests, FATs, SATs.
• Train Manufacturing personnel on new/revised operating procedures.
• Approve commissioning documentation and validation protocols.
• Troubleshoot and remediate deviations/exceptions found during Validation execution.

Qualifications, Skills, And Experience:

• BS or MS degree in Engineering
• 8+ Years relevant Industry experience.
• Ability to effectively communicate with all levels within the organization
• Ability to build collaborative relationships with colleagues and clients
• Demonstrated effectiveness in a dynamic, fast-paced, and ever-changing environment.
• Able to deal with pressure, take on challenging projects, manage competing priorities, and anticipate problems in advance