Process Engineer

Description:

Top three "Must Haves":

1. Works with Clients and industry experts/consultants to create design specifications, process flows, general arrangement drawings, component specifications, and process control strategies.
2. Provide technical expertise related to the process, equipment, and business systems that drive strategic improvements within inspection and packaging.
3. Development and continuous improvement on packaging solutions and/or processes by maintaining vendor relationships, evaluating current systems and processes, implementing new or custom process solutions, and providing floor support and guidance to cross-functional teams and manufacturing personnel.

The Engineering department is responsible for supporting CGMP operations through process engineering, facilities and utilities engineering, calibration, process improvement and automation, packaging, capital projects, while maintaining compliance with regulatory standards.

Process Engineering: This role is responsible for overseeing and optimizing manufacturing processes related to the production, inspection and packaging of sterile biologic drug products.

Designing, implementing, and improving manufacturing processes.

The Process Engineer will support ongoing activities by assisting in troubleshooting mechanical problems, process problems and identifying improvements in operations to minimize interruptions maximize utilization and supporting new and ongoing projects.

This position will further assist in the management and planning of project budgets and schedules and provide contractor oversight.

Automation Engineering: is responsible for effectively designing, integrating, maintaining and supporting various Distributed Control Systems, Programmable Automation Controllers (PLCs), Human Machine Interfaces (HMIs), and Supervisory Control and Data Acquisition (SCADA) systems.

Includes developing and improving automation software applications and strategies based on the latest GAMP guidelines, developing automation controls and application programs and graphical user interfaces in accordance with design requirements, troubleshooting, improving and implementing automated control systems, compiling/maintaining automation requirements and design specifications, and interfacing with manufacturing and other end users of the system and implement necessary changes to improve system s overall efficiency.

Facility Engineering: is responsible for improving processes and systems associated with the facility, in a way that ensures the safety of the employees and public, ensures compliance (quality, safety, and statutory), and improves physical asset readiness and lifetime through projects and continuous improvement of maintenance and calibration plans.

Facility Engineering puts programs, designs, processes, and systems in place for the facility and associated systems/utilities to expand, extend, or enhance their design/commissioned/validated state.

Reliability Engineering: focuses on developing and implementing reliability plans to maintain manufacturing and non-manufacturing assets in compliance with cGMP s, EHS&S and intended product requirements while maximizing equipment OEE and minimizing risk of unplanned failures at benchmark best practice cost effectiveness.

Develops improvements and engineering controls of non-manufacturing assets to reduce costs, increase efficiency, or to incorporate safety and/or environmentally sustainable measures.

1. Specific Duties, Activities, and Responsibilities:

General Engineering Skills:

• Effectively document work performed following required documentation practices
• Be available and respond to site as part of the on-call rotation
• Escort and supervise contractors through facility for routine inspections or repairs, ensuring they complete activities per procedure or agreements
• Draft SOPs for building operation, systems, maintenance, and calibration
• Provide engineering guidance and execution on facilities and equipment projects
• Support Maximo/Trackwise (CM/CMR/CC) workflow
• Use hand tools, power tools, and delicate testing equipment in performance of duties
• Complete non-routine repair work orders for regulated and unregulated systems
• Identify and implement improvements for established systems and maintenance schedules
• File and maintain controlled documents
• May act as a technical resource within own work group/project team
• Collaborate significantly with cross functional groups including Validation, Quality Control, Manufacturing, Process Development, and Facilities
• Assist in responding to customer/regulatory audit observations and corrective actions
• Review and approve changes to assess impact on validated systems
• Perform troubleshooting as it relates to assigned job duties
• Provide technical assistance and training for manufacturing or maintenance personnel
• Interact with other departments to schedule activities around the production schedules of the cGMP Manufacturing and Process Development departments.
• Apply technical and functional knowledge to conduct experiments/research in assigned area
• Work independently to solve problems of moderate scope

Process Engineering Skills:

• SME (Subject Matter Expert) on more than one validated system
• Optimize manufacturing processes to produce sterile manufacturing, including upstream and downstream processes while focusing on isolation technologies.
• Design and implement process improvements to enhance product quality, yield, and efficiency.
• Collaborate with cross-functional teams, including manufacturing and quality assurance to support product commercial manufacturing activities.
• Lead investigations into process deviations, identify root causes, and implement corrective and preventive actions.
• Participate in technology transfer activities to ensure smooth transfer of processes from development (PPQ) to manufacturing
• Support selection and installation of manufacturing equipment
• Participating in commissioning and qualification activities, including IQ/OQ/PQ
• Create and maintain all aspects of equipment design files
• Perform process risk assessments
• Maintain project compliance in accordance with the site quality management system
• Guide the specification and selection of manufacturing/utility equipment to support site facility/ process needs
• Develop standard processes to evaluate future capital projects
• Apply and enhance existing validation programs for the validation of new and existing production and laboratory systems, including major capital projects and continuous improvement of systems

Position Requirements:

Education/Experience:

• Bachelor's degree in Chemical/Mechanical/Electrical Engineering or appropriate scientific discipline with XX years of relevant experience, preferred
• Associate s Degree with XX years of relevant experience
• PE / Registered Engineer in training, preferred
• OSHA 10 or equivalent a plus, preferred
• OSHA/IOSH/NeBOSH Certification or equivalent, preferred (Facility Automation Only)
• XX years of Project Engineering related experience preferred
• XX years within the pharmaceutical or biotechnology industry with a focus on sterile biologics manufacturing, inspection and/or packaging
• Highly skilled and/or certified in multiple trades
• Must be able to read and understand English-written job instructions and safety requirements