Process Engineer II

Pay range: 35-45/hr
*depending on experience

Process Engineering is responsible for analyzing and assessing supplier and in-house processes to determine process capability. Identify and drive process improvements. Support supplier assessment and selection process.

Employee will work with the implementation of new product development and process implementations. The documentation/qualification activities include but not limited to: feasibility studies, validation protocols, standard operating procedures changes, training material, drawings, raw material specifications updates etc. This resource will manage the site timeline for the project and will participate in the project management activities. This contractor will engage with suppliers and manage all external responsibilities.

Design and develop processes and equipment to improve productivity. Provide process control measures through validation plans, data analysis, and statistical process control techniques. Documentation and communication skills to manage projects, vendors, test plans, and present cost justifiable action plans and reports. Organizational skills to manage/prioritize task assignments, amongst unplanned troubleshooting tasks.
Maintain a clean and safe work environment for self and others. Display a sense of urgency, sound judgment, and pride in workmanship. Display self-motivation and the ability to work independently and as part of team. Utilize upward communication to keep supervisor informed of task status, job-related problems and other information related to work activity.

ESSENTIAL FUNCTIONS:
- Understanding of FDA regulations surrounding the manufacture of medical devices, GMPs, and process validations.
- Experience with change documentation package.

-Statistical analysis and feasibility studies for new process
- Ability to write clear and concise Test Protocols and Procedures
- Good written and verbal skills
-Self driven individual and result-oriented person

- Experience with manufacturing environment and automated machines. Pharmaceutical experience is considered a plus.
- Knowledge of modern computer programs to include project management software. Strong Computer skills & MS office suite (Excel, Word, Project etc.)
- Ability to express ideas both in written and oral communications.
- Ability to coordinate with different people who have different priorities and agendas to accomplish the task at hand.
- Ability to deal with contractors in order to assist them with the equipment process commissioning.
- Excellent interpersonal and reasoning skills.
- Knowledge of design engineering tools such as AutoCAD, standard machine shop processes, and specialty shop capabilities.
- Follow all certified standards, GMP, OSHA, plant policies and procedures
- Sets the standard for timeliness, work ethic, and personal integrity
- Positive attitude, result-oriented person.
- Ability to manage multiple task in a high paced environment and willing to adapt and address scope changes.

Education

Education required/ preferred: B.S. Mechanical or Electrical Engineering

• Experience:
  Minimum 2 years of experience preferably in a medical manufacturing industry. Understanding of FDA regulations surrounding the manufacture of medical devices and GMPs.
• Strong technical expertise on manufacturing equipment and process
• Project management experience
  Manufacturing equipment validation, Documentation updates &
  • Preferred: Experience with printing systems and labeling management systems
    

Preferred Skills/Qualifications:
Experience using Microsoft Office Software, Agile, Minitab or equivalent QMS/statistical analysis software