Sr. Process Engineer

This position is responsible for planning, monitoring, improving, and controlling all production activities. While also conceiving, planning, developing, budgeting, and executing projects for optimizing production capacity, capability, and quality, while also ensuring optimal levels of energy conservation and environmental improvements. This position is also responsible for executing operational excellence initiatives across the site including DMAIC, standard work, 5S, etc.

JOB DUTIES:

• Plan, monitor, improve, and control Production output for each line to ensure that plant goals are achieved.
• Responsible for helping update all paperwork for the Production area, from daily output to lot specific batch sheets (when needed) as well as all Quality related items – SOP, ETS, QAR’s, etc….
• Responsible for working closely with the Quality department on all Validation, Qualifications, and testing of products.
• Monitor production trends by statistical analysis and react to problems, trends and opportunities within the production process.
• Coordinate with Production, Quality, and Maintenance Departments to develop strategies to increase production, such as: improvement of potencies, reduction of costs, and process control.
• Responsible for start-up validation and testing of units to pass production regulation requirements.
• Responsible for working with the Quality and Validation Departments for all product Validations. Also Responsible for making sure Production follows Protocols during Validations.

• Work with Regulatory Compliance group to create an effective Validation Plan
• Provide troubleshooting and production support expertise for instrumentation, control technology, and/or production equipment.
• Document Maintenance procedures on equipment

• Develop, submit, manage, and implement capital orders for new or replacement equipment.
• Oversee contractors working on capital projects, ensuring that OSHA standards are met.
• Interface with Project and Refining Engineers, Production, Maintenance and Plant laboratories to coordinate capital project work.
• Write operating instructions for production process changes.
• Write up standard work procedures for critical job tasks.
• Ensure that new equipment is installed according to standards and protocols.
• Verify control schemes, interlocks, and safety devices designed by contractors.
• Maintain Programmable Logic Controllers in a valid state as required by the FDA.

• Size controlling and monitoring instrumentation when new equipment is installed.

• Provide training to Production Operators in the proper operation of new equipment.
• Collaborate with individuals at other facilities to coordinate process developments.
• Provide technical assistance and piloting for process startups, process modifications, and process problem trouble shooting.
• Work with Information Services Department to provide process data on the computer network for analysis by Engineering, Production and Laboratory personnel.

• Identify necessary training for maintenance of electrical and control equipment.
• Identify and develop Automation opportunities for site and develop capital plan to achieve.
• Identify and develop plan for Electronic Batch Records for the Salisbury facility.
• Identify and Coordinate Process Improvement activities across the Salisbury facility.
• Learn and understand the Budgeting process for the Salisbury Facility.
• Responsible for all Validation and Qualification activities – writing, executing, and Final Summary.
• Responsible for getting all P&ID, Electrical, and mechanical drawings up to date.
• Work with Technical group to develop Quality centric process improvements.
• Other duties may be identified and assigned as necessary.

EDUCATION AND EXPERIENCE:

• Bachelor’s degree in Engineering required, Mechanical Engineering preferred
• Demonstrated ability to build and motivate a high performing team through developing and empowering team members.

QUALIFICATIONS:

• Ability to independently plan and execute projects.
• Ability to manage multiple tasks.
• Strong oral and written communication skills.
• Advanced mathematical, analytical and problem-solving skills.
• PC literate with the proficiency in Microsoft Office applications (excel, word, power point, and project software)
• Strong Project Management skills.

• Excellent attention to detail.
• Promotes teamwork and cooperation.
• Green Belt in Six Sigma.
• Experience working in a dusty environment with explosion hazards.
• Experience in an FDA regulated facility.
• Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. 
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. 
• Ability to write documents such as Standard Operating Procedures, PM’s, routine reports, and correspondences. 
• Ability to speak effectively before groups of contractors, designers, consultants, employees of organization, and/or senior members of leadership team.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of the job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; use hands to finger, handle, or feel; and reach with hands and arms. The employee is occasionally required to sit; climb or balance, stoop, kneel, crouch, or crawl. The employee may occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include peripheral vision and depth perception.

Full time

Regular

Colleague

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