Manufacturing Process Engineer, Senior - 1 Year Contract

				Overview:

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.

Responsibilities:

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.

Qualifications:

*  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
			

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