Manufacturing Process Engineer, Senior - 1 Year Contract

Remote Work: No

This position is responsible for providing facilities and manufacturing support (continuous/quality process/ improvement and troubleshooting) in a regulated GMP environment, new site/new process/ new equipment commissioning and validation, and technology improvement. To ensure successfully transferring and  bring up new Vietnam site.

This  employee will be responsible to support manufacturing activities and transferring activities from China to Vietnam, meeting Line Transfer Release Requirements and Mass Production Release Requirements.

• Validate Manufacturing Line layout setup, make sure it meets the continuous flow.
• Process optimization, make the manufacturing data are meet or better than China's data( Metric data: Yield /Std hour/ Operator quantity /UPH/ Space/ Travel distance/Work in process.
• Front End/Back End Process Validation for Multiple Qual Builds
• Perform first article inspection for each pilot build in collaboration with Quality SDE including root cause analysis and failures and corrective and preventive actions.
• Check packing process to meet specification( included package and labeling )
• Support Training to Operators based on the Manufacturing Instructions
• Validate Fixtures and Tooling implementation for Front End/Back End. Escalate any fixture damage and fixture gap of impacting capacity.
• Communicate build status related to Mfg. processes.
• Provide Support with Lean-Six Sigma and Industry 4.0 activities.
• Resolve any manufacturing issue or problem, ensuring production sustainable and no build schedule impacted.
• Manage engineering change and implementation.

• Minimum Education:
o BS degree in Engineering

• Minimum Work Experience (years):
o At least four (4) years of systems integration experience working with, designing, building and troubleshooting electromechanical systems, PLC’s, data acquisition systems, electronic signals, process automation, etc.

• Key Skills and Competencies:
o Regulated (GMP) environments including Medical Devices, Personal Care, or Pharmaceutical manufacturing.
o Systems integration.
o Equipment/process qualification/validation.
o Preparing and training technicians/operators
o Printing and web handling.
o Working knowledge of LEAN and/or Six Sigma (E.g., Design of Experiments & Root-Cause Analysis).
o Creating cost models and performing feasibility analysis.
o Understanding of computers, networks and information systems.
o Working with cross-functional teams including Product Development, Analytical, Safety, Regulatory, Technology Assurance (or equivalent), and Quality Assurance (where applicable), in a technical role.

Position Specific Information:
• Travel Requirements - 50% of the time
• Personal Protective Equipment (PPE) Required (safety glasses, steel-toed boots, gloves, etc.): Steel-toed boots, safety glasses, others supplied by company.

U.S. Only – Frequency Definitions for Physical Activities, Environmental Conditions and Physical Demands:
Never – 0%
Occasionally - 0-20 times per shift or up to 33% of the time
Frequently - 20-100 times per shift or 33-66% of the time
Constantly - Over 100 times per shift or 66-100% of the time

Physical Activities (U.S. only):
Select the frequency for each item on the below list (never, occasionally, frequently, constantly).
• Ascending or descending ladders, stairs, scaffolding, ramps, poles and the like. (Occasionally)
• Working from heights such as roofs, ladders, or powered lifts. (Occasionally)
• Moving self in different positions to accomplish tasks in various environments including awkward or tight and confined spaces. (Occasionally)
• Remaining in a stationary position, often standing or sitting for prolonged periods. (Occasionally)
• Stooping, kneeling, bending, crouching, reaching, pushing/pulling. (Occasionally)
• Moving about to accomplish tasks or moving from one worksite to another. (Constantly)
• Adjusting or moving objects up to 20 pounds in all directions. (Occasionally)
• Communicating with others to exchange information. (Constantly)
• Repeating motions that may include the wrists, hands and/or fingers. (Never)
• Operating machinery and/or power tools. (Occasionally)
• Operating motor vehicles, industrial vehicles, or heavy equipment. (Never)
• Assessing the accuracy, neatness and thoroughness of the work assigned. (Occasionally)

Environmental Conditions (U.S. only):
Select the frequency for each item on the below list (never, occasionally, frequently, constantly).
• Exposure to extreme temperatures (high or low). (Occasionally)
• Outdoor elements such as precipitation and wind. (Occasionally)
• Noisy environments. (Occasionally)
• Other hazardous conditions such as vibration, uneven ground surfaces, or dust & fumes. (Occasionally)
• Small and/or enclosed spaces. (Never)
• No adverse environmental conditions expected. (Never)

Physical Demands (U.S. only): (Light work that includes moving objects up to 20 pounds.) Must be able to see color. (No)

Rewards Only Section:
FLSA Exemption (U.S. only):
For Exempt classifications only, what exemption was used when grading the job
1) Administrative
2) Computer
3) Professional
4) Executive
5) Outside Sales
6) Highly compensated