Process Engineer

Job Title

Improves safety, quality, and productivity of a fast-paced solid dose pharmaceutical operation. Consistently seeks for and evaluates methods to improve overall customer satisfaction through improved manufacturing efficiencies. Serve as the main point of contact for manufacturing and/or packaging processes in their area regarding safety, quality, and continuous improvement activities.

Essential Functions

Department rep for FAT and SAT Documentation Completed (Engineering owns) Works in parallel with Project Engineering, ensuring user requirements are appropriately identified and integrated. Coordinates the documentation of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).

Accurate, Up-to-Date SOPs Leads the 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. Manages 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). Works 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 Conducts reviews and approvals of equipment, product, and process validation documents and cleaning validation documents. Monitors, tracks, and trends production and changeover cycle times (OEE), equipment downtime, and identifies and implements improvements to processes using continuous improvement methods. Performs annual review and updates to Bill of Material (BOM) routers as needed based on changes to process cycle times. Manages and tracks equipment inventory, removal and return to service processes. Ensures that processes comply with all cGMP regulations regarding process and cleaning validation. Completes exception investigations, identifies and implements effective corrective and preventative actions to prevent recurrence. Regular participation in daily production operations meetings and team problem solving efforts. Works 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. Candidate may also have to assist in production efforts when necessary.

Minimum Requirements

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 Strong working knowledge of Microsoft Office products including Word and Excel

Other Skills/Competencies Drive for Results Problem Solving Timely Decision Making Written Communications Process Management Time Management Incorporates Mallinckrodt Core Values in daily routine: Patient-Centric Collaborative Innovative Integrity

Working Conditions:

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.

The expected base pay range for this position is $80,000 - $100,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills and experience. This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.

Relocation Assistance will be considered for the ideal candidate.

This position is not eligible for visa sponsorship. Applicants must be authorized to work in the United States without current or future sponsorship needs.

EEO Statement: We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.