Description:

•The Senior Process Engineer provides process engineering, project engineering and maintenance support to the Manufacturing Facility

•Develop and establish maintenance/engineering tools/programs to ensure that the facility is kept in a good state of repairs as well as all process equipment are cGMP compliant from a facility, maintenance and engineering perspective

•Direct, evaluate and assist capital engineering and process improvement projects

•Facilitate requisitions or equipment and parts

•Serve as equipment/facility expert and interface with regulatory agencies on audits etc

•Develop schedules and performance requirements using appropriate verification tools and techniques to manage project scope, schedule and cost ensuring that project goals are met on time and within budget

•Facilitate engineering projects using the Stage Gate approach from feasibility to project close-out

•Measure project performance using appropriate systems, tools and techniques, evaluate appropriate sources for project information and dissemination of information as appropriate to relevant employees and outside partners

•Analyze resources and priorities to be applied to assigned projects and perform risk management activities to minimize project risks

•Direct and or assist in the design and execution of all capital projects assigned

•Support project development with load calculations of flow, cooling capacity, heating capacity, pressures, etc

•Provide process engineering support for required equipment upgrades and or modifications and champion these efforts including writing and directing all change control activities/ deviations as required by our Quality Systems, OSHA etc

•Perform design reviews and create design review reports

•Investigate and, where possible, devise /implement plans to eliminate any mechanical or maintenance problem which would affect production and work towards successful resolution

•Help develop efficient PM plans for all key pieces of manufacturing equipment etc

•Provide troubleshooting expertise in all areas of plant operations and maintenance

•Assist in and or champion investigation of deviations that are facilities/maintenance related, Train SMEs in problem solving techniques and ensure the appropriate corrective actions are taken

•Use statistical tools in analyzing data to predict trends, measure process capability, improve operating procedures or preventative maintenance procedures, identify bottle necks, and equipment reliability

•Asist in writing regulatory documents for FDA submission as required

•Continuously monitor the manufacturing operation to look for process optimization /debottlenecking opportunities and make technical engineering recommendations/changes as deemed necessary

•Serve as the technical liaison for all OSHA, regulatory and other audits that relate to the maintenance/facility aspects of the manufacturing facility

•Create capital expenditure requests, purchase requisitions and submit for approval

•Train Process Engineers in Manufacturing processes and utility systems

•Prepare annual evaluation and operational assessment reports of critical systems and equipment for review and final approval

Additional Skills & Qualifications:

-Bachelors degree in Mechanical, Biomedical, or Chemical Engineering

-4+ years in a cGMP manufacturing environment

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.