Job Information
Mallinckrodt Pharmaceuticals Principle Process Engineer in St. Louis, Missouri
Job Title
Principle Process Engineer
Requisition
JR000014286 Principle Process Engineer (Open)
Location
Fenton, MO (Pharma) - USA040
Additional Locations
St. Louis, MO
Job Description
SUMMARY OF POSITION:
The Principal Process Engineer serves as main point of contact for manufacturing processes regarding safety, quality, and continuous improvement activities. Responsible for all engineering, process improvement, and equipment administration functions within manufacturing. Is the leader of equipment and process troubleshooting efforts; coordinating other support groups to return equipment to service. Is the leader of product/process/equipment failure root cause investigations and implementing corrective actions. Provides change control authority to ensure the validated status of equipment is maintained. Technical requirements include a thorough and demonstrable knowledge of cGMP's and applicable Industry standards.
ESSENTIAL FUNCTIONS:
Works closely with Research & Development (R&D) organization project managers and formulators for new product transfer into the facility.
Identifies and implements improvements to existing processes using continuous improvement tools.
Responsible for process changes including change control management.
Ensures that processes comply with all cGMP regulations regarding process and cleaning validation.
Subject matter expert for all production processes
Completes investigations and implements effective corrective and preventative actions.
Write and update batch records for new and existing product lines.
Ensures accurate completion of all paperwork and documentation including batch records, equipment, etc.
Design, validate and commission new production equipment and tooling, monitor modifications and upgrades, and troubleshoot existing processes.
Write and execute validation documentation (process, cleaning, and equipment) for new and existing product lines.
Regular participation in production daily operations meeting and lead team problem solving efforts.
Collaborates across sites to identify and implement best in class process and safety improvements.
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.
Provide technical support and problem resolution.
Assist Operations Manager and Project Engineering in development of project scope and cost details for capital projects.
Develops and executes low to medium complexity capital projects.
Identifies new equipment and technologies to support continuous improvement and capacity expansion of core capabilities.
Ensuring that process critical maintenance is completed
Candidate may also have to assist in production efforts when necessary.
Coordinate projects and serve as project manager for assigned projects.
Perform other duties as assigned.
MINIMUM REQUIREMENTS:
Education:
BS degree in Industrial, Manufacturing, Chemical Engineering or related field.
Experience:
Minimum of 8 years of related experience in pharmaceutical industry. Solid dose production experience is preferred.
Preferred Skills/Qualifications:
Strong knowledge of chemistry, physics, and engineering principles.
Experience with manufacturing processes.
Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format
Other Skills:
Knowledge of FSA, NFPA and OSHA regulations
Excellent communication skills, both oral and written
Strong working knowledge of Microsoft Office products including Word and Excel
RELATIONSHIPS WITH OTHERS:
The Principal Process Engineer supports the pharmaceutical manufacturing process and may be assigned a general plant support role. Position interacts with production technicians, quality assurance/control, production managers, project managers and leadership team member, R&D, corporate engineering, and external vendors .
WORKING CONDITIONS: Works an equal amount of time on the production floor in a manufacturing environment and an office type environment. The time spent on the production floor may be extended periods of time within a manufacturing facility
DISCLAIMER:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.
Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.