Process Engineer

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

Department rep for FAT and SAT Documentation Completed (Engineering owns)

Work in parallel with Project Engineering, ensuring user requirements are appropriately identified and integrated. Coordinate the documentation of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).

Accurate, Up-to-Date SOP's

Lead SOP biennial review process by actively managing procedural updates and driving cross-functional collaboration to accurately reflect the current state process requirements and meet due dates. Manage tracking system to ensure effective communication on status of SOP updates.

Operations Business Fundamentals

Ensure costs are correctly identified, communicated, costed to appropriate cost centers, and approvals are obtained from appropriate area owners and/or clients (as needed). Work with Focus Factory Manager, Sr. and/or Principal Process Engineer, and Project Engineering to develop project scope and cost details for capital budget preparation. Provide technical support and problem resolution in support of routine daily production, Safety, Quality Compliance, and schedule adherence.

New Product Launch Facilitated in Department

Assist in the successful creation and on time completion of documentation and implementation of new processes and product transfers in the assigned department.

Production Processes Managed

Conduct reviews and approvals of equipment, product, and process validation documents and cleaning validation documents. Monitor, track, and trend production and changeover cycle times (OEE), equipment downtime, and identify and implement improvements to processes using continuous improvement methods. Perform annual reviews and updates to Bill of Material (BOM) routers as needed based on changes to process cycle times. Manage and track equipment inventory, remove and return to service processes. Ensure that processes comply with all cGMP regulations regarding process and cleaning validation. Complete exception investigations, identifies and implements effective corrective and preventative actions to prevent recurrence. Participate in daily production operations meetings and team problem solving efforts. Work with plant safety to maintain and improve process specific safety requirements and information. Assist in developing training programs and/or SOPs to enhance skills sets and reduce defects. Support Customer or Regulatory agency audits as the subject matter expert for assigned processes. Assist in production efforts when necessary.

Education

• BS degree in Industrial, Manufacturing, Chemical Engineering or Packaging Engineering/Technology or related field preferred. Solid knowledge of chemistry, physics and engineering principles.

Experience:

• Minimum of 1-3 years of related solid dose production experience. Experience with manufacturing or packaging processes.

Preferred Skills/Qualifications:

• Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format
• Knowledge of FDA and DEA regulations
• Knowledge of Quality Systems
• Knowledge of cGMPs for Finished Dosage Products
• Understanding of basic statistical principles, basic knowledge of validation principles, techniques, and regulatory experience
• Ability to quickly identify, communicate and/or resolve issues

Other Skills/Competencies:

• Strong working knowledge of Microsoft Office products including Word and Excel

Drive for Results Sets and maintains high performance standards for self and others that support the organization's strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.

Problem Solving Uses rigorous logic and methods to solve difficult problems with effective solutions; probes all fruitful sources for answers; can see hidden problems; is excellent at honest analysis; looks beyond the obvious and doesn't stop at the first answers.

Timely Decision Making Makes decisions in a timely manner, sometimes with incomplete information and under tight deadlines and pressure; able to make a quick decision.

Written Communications Is able to write clearly and succinctly in a variety of communication settings and styles; can get messages across that have the desired effect.

Process Management Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient workflow; knows what to measure and how to measure it; can see opportunities for synergy and integration where others can't; can simplify complex processes; gets more out of fewer resources.

Time Management Uses his/her time effectively and efficiently; values time; concentrates his/her efforts on the more important priorities; gets more done in less time than others; can attend to a broader range of activities.

Incorporates Mallinckrodt Core Values in daily routine:

• Patient-Centric: Our decisions and actions are guided by our commitment to improve lives.
• Collaborative: We are inclusive and work together towards our common goals.
• Innovative: We are agile, always seeking new ways to continuously improve our performance.
• Integrity: We do what we say we are going to do.

Works an equal amount of time on the production floor in a manufacturing facility and an office type environment. The time spent on the production floor may be extended periods of time within a manufacturing facility.

Salary Range: 62,503.00 - 100,005.00