Manufacturing Process Engineer
The Manufacturing Process Engineer will work closely with Production Managers, R&D, Facilities & Engineering and Validation to determine and implement the most cost-effective equipment and processes in a cGMP compliant powder and tablet production environment resulting in increased quality, productivity, regulatory compliance, efficiency and effective management of human capital. Responsible for supporting capital projects associated with the selection and installation of manufacturing and packaging equipment and facility related cGMP critical systems.
Essential Duties and Responsibilities include the following:
- Review equipment and processes challenging the current conditions for improvements.
- Show by example. Exhibit flexibility. Willing to work off-shift and weekends as required.
- Interact with peers and employees to increase their knowledge on key topics such as metrics (including SPC, OEE), SMED, productivity, process flow and value stream mapping, etc.
- Create, maintain and improve manufacturing assembly line, workflow processes, and detailed work instructions.
- Design, document, procure, qualify, implement, and improve fixtures, tools and provide production support with a focus on efficiency, increasing production yield, minimizing waste and quality incidents.
- Provide engineering leadership in the design, development, and qualification of products and processes. This may include feasibility studies, designing & implementing evaluations (DOE's) and Equipment Qualifications.
- Author technical documents including Standard Operating Procedures (SOPs).
- Design and/or qualify tooling and new equipment in conjunction with team to improve manufacturing processes.
- Document and perform equipment calibration, Preventive Maintenance, repairs, validation and other equipment lifecycle processes to support production and product release.
- Analyze results of process capability studies and make recommendations.
- Work closely with cross-functional groups (i.e. Manufacturing and Packaging, R&D, Facilities & Engineering, Validation, Technical Affairs and Quality) to achieve company and departmental objectives.
- Makes recommendations to management on equipment performance and design improvements.
- Assist in product development projects to design, develop, improve and qualify new processes and/or components.
- Lead cross functional team in the design and installation of capital projects focused on new and upgraded projects including manufacturing and packaging equipment and facilities. Activities include defining the scope of the project, creating specifications and requirements, creating project documentation, obtaining competitive bids, assessing bids, purchasing equipment, overseeing installation and leading training and release of equipment to manufacturing.
- Coordinates, supervises and facilitates projects with outside vendors.
- Manages timeline and budget requirements in support of equipment and facility capital projects.
- Investigate existing manufacturing methods and processes.
- Develop concept designs in concert with the R&D, Technical Affairs and Validation Departments.
- Develop experiments in cooperation with Validation and Technical Affairs in support of method development and new equipment.
- Support the creation of validation protocols, FAT's, investigation reports and SOP development.
- Maintain project milestone dates and identify time and cost drivers.
- Develop cost estimates for projects. Determine potential savings and calculate ROI.
- Use leadership skills to develop a high functioning team accountable for results.
- Use Project Management Tools and Principles to ensure completion of projects according to established goals.
- Analyzes new processes and equipment with the intent of achieving continuous improvement of present methods. Facilitates, educates and partners with production management and colleagues to lead a culture of continuous improvement efforts.
- Develop and support methods to collect suggestions and feedback for continuous improvement from all areas of the company.
- Implement 5S and process improvement methodologies including audit measures to track sustainability.
- Track labor efficiency in cooperation with the manufacturing managers. Identify opportunities for improvement including labor productivity, set-up and changeover times, cycle time, etc.
- Study and rearrange material flow and operations sequence.
- May be required to perform other duties as assigned or as needed.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education and/or Experience:
- BS in Mechanical, Electrical, Electromechanical or Biomedical Engineering from a 4-year college or university or equivalent 5+ years manufacturing engineering experience in a manufacturing environment required.
- Experience in Pharmaceuticals is a plus.
Knowledge, Skills and Abilities
- Demonstrates oral and written skills.
- Effectively uses tools to facilitate group activities.
- Champions change through effective mentoring of teams and individuals.
- Manages the interactions between people to achieve desired outcomes.
- Ability to design, document and control layouts for facilities, lines and work stations.
- Understand and apply computer applications and systems.
- Proficient in the use and understanding of lean concepts and tools.
- Leads the implementation of lean projects.
- Mentor and coach lean agents.
- Demonstrated experience in implementing technical strategy for a complete pharma line projects and coordinate with applicable cross-functional leader.
- Possess strong mechanical troubleshooting skills.
- Must understand process controls.
- Preparing User Requirements, Testing Procedures, Standard Operating Procedures, and related documents.
- Detail oriented and strong written and verbal communication skills.
- Ability to work independently, within prescribed guidelines, or as a team member.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this 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 use hands to finger, handle, feel, reach with hands and arms. The employee is frequently required to stand, walk, talk and hear. The employee must regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision and peripheral vision.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Manufacturing Process Engineer