Mallinckrodt Pharmaceuticals Process Engineer in Hobart, New York
Job TitleProcess Engineer
JR000011278 Process Engineer (Open)
Hobart, NY (Pharma) - USA036
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 main point of contact for manufacturing and/or packaging processes in their area in regards to safety, quality, and continuous improvement activities.
Department rep for FAT and SAT Documentation Completed (Engineering owns)
Coordinates the documentation of FAT (Factory Acceptance Testing) and SAT (Site Acceptance Testing).
Accurate, Up-to-Date SOP's
Leads the SOP review process by actively managing procedural updates and driving cross-functional collaboration to meet due dates. Manages tracking system to ensure effective communication on status of SOP updates. Prepares reports for management on compliance.
Ensures rework costs are correctly identified and obtains approvals from client on how rework will be performed. Ensures rework is correctly completed. Provide technical support and problem resolution.
New Product Launch Facilitated in Department
Assist in the successful and on time completion of documentation and implementation of new process and product transfers in assigned department.
Production Processes Managed
Ensures the official documents receive appropriate sign-offs. Identifies and implements improvements to existing processes using continuous improvement tools. Ensures that processes comply with all cGMP regulations in regards to process and cleaning validation. Completes exception investigations and implements effective corrective and preventative actions to prevent recurrence. Regular participation in production daily operations meeting and team problem solving efforts. Work with plant safety to maintain process specific safety 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. Work with Focus Factory Manager, Engineering Services Lead and Project Engineering to develop project scope and cost details for capital budget preparation. Candidate may also have to assist in production efforts when necessary
BS degree in Industrial, Manufacturing, Chemical Engineering or Packaging Engineering/Technology or related field preferred. Solid knowledge of chemistry, physics and engineering principles.
Minimum of 1-3 years of experience of related experience solid dose production experience. Experience with manufacturing or packaging processes.
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
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 work flow; 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.
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.