Senior Process Engineer

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.

Ortho is known in the industry as a leader in customer service and support. Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do. It’s who we are. If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

As the company continues to grow we are seeking a Senior Process Engineer to work in our Rochester, NY manufacturing facility. The Senior Process Engineer will be responsible for supporting new and existing equipment located at the Rochester Site. This position will work within a team-based environment and is responsible for both manufacturing and facilities equipment and will manage capital and expense projects. Act as liaison to Manufacturing in order to support new equipment development, installations, and startup. The individual will also provide the manufacturing team direct support in routine problem solving of a moderate to complex nature and identifying and correcting issues. Minimization of maintenance costs while protecting and prolonging the productive life of assets is a goal of this position as well as implementation and optimization of engineering, maintenance, calibration, and operations processes. 

The individual will be focused on building operations capability for a new consumable manufacturing, including working with R&D teams on Design for Manufacturability, as well as equipment and process design.  The engineer will ensure new and/or modified equipment is properly documented (from equipment requirement through validation and operational SOPs) and all processes are clear for operation.  Ensures appropriate procedures are in place prior to completion of any project.

This is a first shift position. Travel required between 25-50% during the development of the product and equipment.  Product Development will be in Rochester, the final manufacturing site will be at the Raritan NJ site.

This position will be based in Rochester, NY.

The Responsibilities

• Design and selection of new production and facility systems, modifications and upgrades to existing equipment as needed.

• Preparation of capital estimates, generation of capital funding, control of project budgets, timely execution of new installations, equipment commissioning/validation, project scheduling and coordination.

• Provide input on product design for manufacturability.

• Completion of documentation to show and ensure compliance with both internal and external regulations and protocols.

• Creation of processes and working to maintain optimization of the production line.

• Alongside Manufacturing personnel, participate in troubleshooting issues, in the event of a problem.

• Provide Manufacturing data collection, provide interpretation and report out of findings.

• Presentation of data and reporting to senior colleagues and management.

• As part of a collective project group, support installation of new equipment in Manufacturing.

• Perform risk assessments, both process and equipment based, to determine root cause of existing issues.

• Continued evaluation of equipment and Manufacturing processes to confirm quality, efficiency and reliability.

• Identifies and facilitates training of new processes.

• Simplifies existing complex technologies to properly train operator and allow them a greater understanding of the equipment and processes.

• cGMP responsibilities will include owning and managing quality events related to process and facility equipment problems and corrective/preventive actions as well as adhering to the associated regulatory and change management actions related to projects.

• Development and periodic review of standard operating procedures and preventive maintenance job plans.

• The individual will plan, fund, and coordinate/lead projects as assigned to meet all performance requirements including cost, quality, maintenance, safety and environmental criteria.

The Individual

• Bachelor’s degree is required, with a masters degree preferred in technical or engineering discipline.

• Certificate in related field (CRM, PMP, etc. a plus) with 2 to 5 years’ experience working in Manufacturing Engineering environment with Maintenance personnel and troubleshooting experience with advanced industrial equipment.

• Must have very strong communication and organizational skills.  Knowledge and experience with Computerized Maintenance Management System (CMMS) a plus.

• Knowledge of FDA and other regulatory guidance is required.

• Must be able to adapt or modify methods to meet varying situations.

• Must be able to act as indicated by approved policies and accepted standard practices.

• The candidate must be creative in taking action in the absence of instructions and develop new and/or improved work methods.

• Must be able to instruct and advise others in work details, direct and assign work to group of permanently assigned employees.

• Demonstrated written and verbal communications skills in formulating and communicating technical objectives into capital projects as well as interpreting and communicating technical content to management and auditing agencies. 

• Candidates who possess a Six Sigma Methodology Certification are preferred for this role. 

• Must be proficient with Microsoft MS Office Suite PC (Word, Excel and PowerPoint).

EOE/AA Disability/Veteran