Principal Process Engineer

Mallinckrodt Pharmaceuticals Hobart, New York
engineer technical analysis engineer engineering team pharmaceuticals operating data management capital manufacturing troubleshooting
November 1, 2022
Mallinckrodt Pharmaceuticals
Hobart, New York
OTHER


Job TitlePrincipal Process Engineer

Requisition
JR000012625 Principal Process Engineer (Open)

Location
Hobart, NY (Pharma) - USA036

Additional Locations

Job Description

The Principal Process Engineer provides technical discipline and leadership required to maintain, plan and implement robust and capable processes. Responsible for all engineering, process improvement, and equipment administration functions within the assigned Focus Factory. Identifies and implements improvements and new technologies to processes to increase productivity, improve quality, improve reliability, and reduce costs. Is the leader of equipment and process troubleshooting efforts; coordinating other support groups to return equipment to service. Is the champion or leader of product/process/equipment failure root cause investigations; implementing corrective actions and preparing sound scientific reports. Ensures consistent application of a Continuous Improvement approach to Reliability, including definition and trending of KPI's to drive team actions. Authors and provides technical support for developing processes and equipment documents including URS, DOE and validation documents. Provides change control authority to ensure the validated status of equipment is maintained. Reviews, monitors and trends daily operating data as needed, issues reports and recommendations based on operating data. Technical requirements include a thorough and demonstrable knowledge of cGMP's and applicable Industry standards.

Essential Functions

Composes User Requirements Specifications (URS) for equipment and upgrades. Maintains control of area process changes including change control management and documentation. Provides adequate and documented monitoring of the process through trending, run reports, and tracking KPI's to identify process improvements. Influences proper operating procedures during the manufacture of finished pharmaceuticals (Compliance with CFR's, Aseptic technique, etc.) Act as Subject Matter Expert for regulatory requirements and current industry guidelines relevant to supported processes. Leads process troubleshooting efforts. Assists in the development and maintenance of process equipment, procedures, batch records, and training materials. Identifies and justifies capital needs for processes. Supports departmental change initiatives for continual improvement, specifically around Operational Excellence, 6-Sigma and Lean Manufacturing applications. Primary departmental driver for cost reduction initiatives. Facilitates technical transfers with R&D. Defines requirements and manages scale-up and implementation for new products. SME for the process including application of all applicable regulations. Provides annual capacity analysis. Provides technical expertise to project management teams during project lifecycles. Performs Startup Manager roles and responsibilities as assigned. Executes low to medium complexity capital projects. Purchases equipment Composes associated CER and processing financial information. Capital funding for outside services as it relates to manufacturing (risk assessments, validation services, process engineering assistance). Position is, at times, hands-on requiring trouble shooting of complex automated equipment and processes. Acts as a subject matter expert for equipment operation and equipment efficiencies.

Minimum Requirements

Education:
Four-year degree in Mechanical, Electrical, Chemical, or Industrial Engineering. (Other qualifications may be considered based on experience.)

Experience:
8+ years in manufacturing environments
Minimum Five (5) years experience working as an engineer in a FDA regulated facility.
Minimum three years of experience in the manufacture of finished pharmaceuticals.

Other Skills/Competencies:
Familiarity with accepted engineering and scientific terms, principles and concepts required.
Ability to use and comprehend AutoCAD, electrical schematics, P&ID drawings
Experience with FDA, NFPA and OSHA codes and regulations.
Working knowledge of MS Word, Excel, PowerPoint, MiniTab and MS Project.
Able to work both independently, within a team, and able to organize and lead a team.
Strong organizational skills.
Strong verbal and written communications skills and ability to communicate clearly and efficiently.

Organizational Relationship

Analytical: Uses a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions; uses logic, mathematics, or other problem-solving tools in data analysis or in generating solutions; logically and thoughtfully sorts through ambiguity and alternatives with rigor and discipline that crystallizes ideas for action; goes beyond analyzing factual information to develop a conceptual understanding of the meaning of a range of information; integrates diverse themes and lines of reasoning to create new insights or levels of understanding for the issue at hand; thinks in terms of generalized models rather than concrete details.
Drives Execution: Coaches, mentors, and motivates project team members and influences them to take positive action and accountability for their assigned work. Demonstrates effective skill in planning, supervising, monitoring, and accomplishing projects. Knows how to organize people, activities, and processes to get things done efficiently and effectively. Exhibits passion for driving process and projects, and for achieving success through continuous innovation and execution to plan.
Project Management: Knows how to organize people and activities; can see opportunities for synergy and integration where others can't; coordinates the diverse components of projects by quality project planning, execution and change control to achieve the required balance of time, cost and quality; manages projects according to a standard process by using a systems development lifecycle; effectively directs and integrates all aspects of a project or program, ensuring that work progresses toward achieving goals and objectives.
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.
Business case development: Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.
Technical Learning: Picks up on technical concepts quickly; can learn new skills and knowledge; is good at learning new industry, company, product, or technical knowledge; does well in technical courses and seminars.

Mallinckrodt Pharmaceuticals 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 genetics. In addition to federal law requirements, Mallinckrodt Pharmaceuticals complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. 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.











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