Senior Engineer, DS Plant Engineering

Leads and manages the identification and implementation of new complex manufacturing equipment or modifications to optimize existing processes and ensure achievement of regulatory and safety requirements including driving project requests and providing scope for project initiation.
Manages and drives the equipment implementation process and tracks projects status, schedule and identify risks.
Oversees the execution, proactively identifies risks, and collaborates with area owners to resolve issues in the pre-production readiness program with regards to wet run checklists, equipment checklist, tracking the use of assets.
Reviews qualification protocol, provides technical expertise, and manages qualification testing to ensure qualification activities meet URS and operational conditions.
Leads the equipment readiness within manufacturing including managing the execution testing of the equipment with the appropriate procedures to confirm it will perform as expected in the GMP runs as part of the New Product Introduction process. In addition, it includes being present/participating in the initial set up and operation of the equipment in a GMP setting.
Responsible for the resolution of issues during testing and initial GMP run.
Proactively identifies and leads complex technical troubleshooting of mechanical and automation issues.
Implements new or adjusted solutions to increase the reliability and availability of equipment in the assigned department.
Generates process improvement projects deriving from troubleshooting, manages projects list and prioritize projects execution.
Drives continuous equipment improvements by optimizing existing equipment with respect to mechanical and automation operability.
Collaborates with reliability engineering and manufacturing to reconcile RPN ranking and operational needs to prioritize reliability projects.
Responsible for identifying solutions to reliability issues, requesting and leading reliability projects as output of reliability program.
Defines equipment-related training programs.
Takes lead on the training program for the department.
Identifies new technical training programs to increase expertise within manufacturing.
Designs and manages execution at scale process studies, i.e. mixing studies, media hold studies, to support process improvements and equipment validation.
Provides technical assessment of results for studies reports.
Determines appropriate CAPA actions based upon deviation investigation.
Owns and executes CAPAs with regards to process equipment operations and on-going validation.
Provides technical input and review for CAPEX projects as user engineers.
Leads manufacturing-driven CAPEX projects including project request submission, project scheduling, budget allocations, procurement, qualification and closing out of change controls.

Engineer, DS Plant Engineering Requirements:

• Requires a Bachelors degree from an accredited institution, preferably in a life science or engineering related field, with six (6) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility, plus a minimum of two (2) years of experience as a manufacturing engineer in a GMP environment or clean room assembly environment.
• In lieu of a Bachelor's degree, will consider an Associate's degree from an accredited institution, preferably in a science or engineering related field, with a minimum of eight (8) years of experience in a GMP environment or clean room assembly environment, plus a minimum of two (2) years of experience as a manufacturing engineer in a GMP environment or clean room assembly.
• Experience in biotech, pharmaceutical manufacturing or device manufacturing is a requirement.
• Experience with equipment qualification or re-qualification.
• Experience with equipment related RCA within Deviations and CAPAs.
• Experienced in Technical Equipment Operations within manufacturing and has an understanding of industry trends and technical troubleshooting experience.
• Awareness in validation activities (Mixing and cleaning) and equipment qualification.
• Experience in Managing and implementing Capital Expenditure programs.
• Must be able to demonstrate basic understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation.
• Understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred.
• Must have strong communication skills to communicate and oversee equipment modifications in conjunction with our maintenance staff.
• Some experience leading meetings, and mastery of some techniques to keep meetings effective and team on task.
• Projects are cross functional and the project scope is limited. Should be able to independently influence peers to achieve a common goal.
• Be able to multi-task and be organized.
• Awareness of proceduralizing safe, cost-effective, and efficient establishment of operational equipment consistent with cGMP regulations.
• Has an understanding or manufacturing equipment performance and availability and can identify areas of improvement and can collaborate in developing protocols to achieve identified improvements.
• Basic understanding of mammalian based biopharmaceutical manufacturing processes, knowledge of regulatory aspects of cGMP.

Senior Engineer, DS Plant Engineering Requirements

Senior Engineer, DS Plant Engineering

• Bachelor's degree required, preferably in a Life science or engineering related field with eight (8) years of cGMP pharmaceutical manufacturing experience in positions of progressive responsibility. Five (5) years' experience as a manufacturing engineer in a GMP environment or clean room assembly environment.

OR

• Associate's degree, preferably in a science or engineering related field with a minimum of ten (10) years' experience as a manufacturing engineer in a GMP environment or clean room assembly environment.
• Ability to demonstrate in-depth understanding of technical equipment, Quality Systems and the interface between equipment and the associated automation.
• Ability to troubleshoot mechanical/automation issues, identify the root cause, plan corrective actions, and implement solutions by cooperating with manufacturing, quality, compliance, and automation.
• Expert understanding of facility technology, system troubleshooting using root cause analysis tools, CAPA's and change controls highly preferred.
• Ability to lead RCAs with cross functional team and identify appropriate CAPA for resolution of root cause.
• Must have strong communication skills to communicate and manage equipment modifications in conjunction with our maintenance staff, automation, validation, compliance, and quality.
• Ability to influence Sr. Management to achieve a common goal and overcome obstacles.
• Strongly desire strong leadership skills and the ability to influence in a team environment and collaborate with peers.
• Must have experience leading technical projects in a biotechnology/pharmaceutical environment including ownership of change controls, functional specifications, P&IDs, and other controlled documents.

Eligibility Requirements:

• Must be legally authorized to work in the United States without restriction.
• Must be willing to take a drug test and post-offer physical (if required).
• Must be 18 years of age or older.