10 Dec, 2020

Process Engineer

  • Thermo Fisher Scientific
  • Santa Clara, CA, USA
Process Engineer   Biochemicals / Pharmaceuticals

Job Description

Position Summary:

Process Sustaining Engineer provides technical and sustaining engineering support to all aspects of operations. Also, establishes and refines operating specifications, improves manufacturing techniques and production yields, and introduces new processes to improve production efficiencies.

 

Provide equipment engineering support for the chip manufacturing organization. Performs engineering assignments of varying complexity under general management direction to improve and keep manufacturing equipment on-line. Execute and leads advanced equipment repairs. Performs/authors IQ, OQ, and PQ on tools. Make recommendations for monitoring key operational instruments, and equipment process parameters used in chip manufacturing. Participates in equipment procurement and transfers from development to manufacturing. Applies knowledge of engineering, mathematics, software, and/or computer sciences to identify, analyze, and solve complex equipment problems.

 

Drive seamless, rapid, and global implementation of material, BOMs, and process changes by supporting the manufacturing change control process(FM737) through coordination of risk assessment meetings, FMEA, and action plan monitoring. Support, analyze, process, and track change orders to minimize processing time between submission and implementation, optimizing department throughput. Support site quality to maintain supplier files and participate during internal/ISO audits to support supplier quality management system for the site.

 

Technical support for masks, substrates, plastics, molds, and other consumables used by the microsarray business. Coordinate complex projects, quality issues, and technical roadmap support between OEM/supplier and company. Drives cross functional team to deal with any changes in process and/or equipment used to manufacture consumables to minimize impact on microarray business.

 

Primary Duties and Responsibilities:

  • Primary technical interface between Development, Field Service, Application Support and Manufacturing Operations.
  • Facilitates meetings with Manufacturing Operations and provides guidance on design changes, parts obsolescence, and any field service instructions. This will require coordination between various departments, sites, and outside suppliers/contract manufacturers.
  • Review and approve ECO / CO’s and technically assess impact to instrument performance.
  • Coordinate the creation of specifications, part numbers, batch records, JDE data, and logistic processes for new products. Insure that validations and other corporate requirements for new product introduction are satisfied. This would include technical leadership in audits and support any regulatory requirements around product labeling /safety.
  • Performs IQs, OQs, PQs, PPQs, PVs, and cleaning validations
  • Ensure that processes and new products are compatible with operations/manufacturing requirements to support the transfer and implementation of new products & processes
  • Responsible for analysis of key manufacturing and QC/process control metrics
  • Conduct investigations and troubleshooting of process failures
  • Responsible for process control monitoring / trending, process improvement, troubleshooting, investigations
  • Provide summary results of findings and recommendations to MRB
  • Participates in process and operation improvement opportunities
  • Responds to internal and external inquiries
  • Complies with company quality management systems, policies and procedures
  • Provides mentorship, if applicable
  • Additional duties/responsibilities according to business needs

 

 

 

Requirements:

 

 

Education:

  • Bachelor Degree in science or technology
  • Experience with molecular biology and/or chemistry
  • Material science background

 

Yrs of related experience:

  • 12+ years
  • 12+ years of manufacturing engineering or manufacturing experience in a pharmaceutical or medical device industry
  • Competencies: (skills, knowledge, abilities)

 

Interpersonal skills:

  • Results oriented, Data analysis, Familiarity with six sigma and statistics, and lean mfg ISO13485:2003 training
  • Computer literate with excellent oral and written communication skills. Good interpersonal and influential skills.
  • Self motivated and works with limited supervision
  • General equipment knowledge of electrical, mechanical engineering.
  • Program Project Management

 

Licenses/Certificates:

None

 

Travel Requirements:

Minimal

 

Working Conditions:

Office and Manufacturing


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