Process Engineer

ESSENTIAL FUNCTIONS:

• Provide technical support for manufacturing operations by tracking, monitoring and troubleshooting processes and equipment for maximum productivity.
• Collaborate with supervisors to drive improvement in production quality and yields.
• Utilize Lean and Six Sigma Methodology to identify and implement cost reduction initiatives and improve process yields.
• Identifies and implements improvements to existing processes using continuous improvement tools.
• Serve as primary site point of contact for the Manufacturing Controls Network which includes Active Directory, HMIs, PLCs and controls contractor management.
• Administrator for Lab X and other in-process instrumentation
• 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.
• Assists with completion of Product Complaint Investigations and responds to customer requests and inquiries
• Maintain batch records, standard operating procedures, process and operating reports, process flow diagrams and other documentation for manufacturing.
• Participate on Departmental or Cross Functional Teams.
• Validate and start-up new processes and new equipment. This includes development and execution of documentation where required.
• Participate and assist in the development of new process technology, equipment, and projects
• Train production personnel on equipment and processes and 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 Project Engineering in development of project scope and cost details for capital budget preparation and execution of small capital projects
• Conduct process audits with management with the respect to Safety, Environmental, Quality, Production, and Cost.
• Occasional coverage of the production floor as fill-in for the production supervisor.
• Manage the Collective Bargaining Agreement (CBA) where applicable.
• Take on special assignments of a technical or engineering nature as required.
• Perform other duties as assigned.

MINIMUM REQUIREMENT

Education: B.S in Engineering, Chemical Engineering or related field.

Experience: Minimum of 1-3 years of experience in process engineering or related field. Directly related experience in pharmaceutical industry is preferred.

Skills/Qualifications:

• Strong knowledge of pharmaceutical manufacturing, plant support systems and engineering principles
• Experience with a wide variety of unit operations and both batch and continuous processes
• Experience and training in Six Sigma, Lean Manufacturing or similar programs is preferred
• Experience in driving efficiency improvements and cost savings in a manufacturing or similar environment is preferred
• Ability to effectively communicate with all levels of the organization, from operations to senior management, both oral and written format
• Ability to apply logical thinking to define problems, collect data, establish facts and draw valid conclusions

Other Skills:

• Knowledge of cGMP and PSM regulations.
• Excellent communication skills, both oral and written
• Strong working knowledge of Microsoft Office products including Word and Excel
• Ability to work independently and provide a high level of initiative and creativity to general duties.
• Attention to detail and good organizational skills
• Basic supervisory skills

Competencies:

• Drive for Results
• Problem Solving
• Timely Decision Making
• Written Communications
• Process Management
• Time Management
• Attention to detail

ORGANIZATIONAL RELATIONSHIP/SCOPE:

Process Engineer reports to the Manufacturing OpEx Leader and supports the pharmaceutical manufacturing process. Position interacts with the quality department, production operators, production supervisors, plant manger, project managers and Leadership team members, R&D and Corporate Engineering. Supervising and direction of reports may be required.

WORKING CONDITIONS:

Plant operates as a 24/7 pharmaceutical manufacturing environment with multiple shifts. Approximately 30% of time will be spent in the office, 70% of time on the floor.

May be required to exert a negligible amount of force continuously and up to 50 pounds of force occasionally to lift, carry, push, pull, or move objects. The job involves sitting, walking, and standing, reaching, talking and hearing. Use of PPE required. Attention to detail required with the visual ability to recognize abnormalities in product.

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. Employees may be required to follow other job-related instructions and to perform other job-related duties as requested, subject to all applicable state and federal laws.

Certain job functions described herein may be subject to possible modification in accordance with applicable state and federal laws. "Commonly associated" is not intended to mean always or only. There are different experiences that suggest other ways or circumstances where reasonable changes or accommodations are appropriate. All activities, demands, conditions and requirements are linked to Essential Job Functions unless marked with an asterisk, which denotes linkage only to marginal function(s)