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Sr. Engineer - Process and Product Engineering

Hayward, CA 94541

Posted: 03/22/2023 Employment Type: Contract Job Category: Engineering Job Number: 551910 Is job remote?: No Country: United States

Job Description

Essential Duties and Responsibilities
  • Design/configure, validate, and implement computer systems for use by Hayward personnel. Contribute to global projects and rollouts when necessary.
  • Maintain a master list of all computer system assets for the site with appropriate level of detail (including GAMP category, risk levels, etc.).
  • Train to become Data Integrity lead for the site.
  • Write, review, analyze and revise Standard Operating Procedures (SOPs), as needed to meet

Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Lead and assist in Quality System records, including non-conformance (NCR) investigations, corrective and preventive actions (CAPAs), and Change Control.
  • May lead a small-scale program or several small projects with moderately complex features under manager supervision.
  • Assists in the financial planning and analysis to justify project approval under manager supervision.
  • Plans, schedules and leads cross-functional team in detailed phases of the engineering work on a project. Ex. Equipment validation, system validation, process transfer etc.
  • Perform data and statistical analysis.
  • Utilize engineering tools to solve problems (e.g. FMEA, Finite Element Analysis, process modeling, SPC, TPM, DMAIC, etc.)
  • Study, investigate, and recommend techniques to improve existing processes and products including equipment, material, or design. Education/Experience
  • Bachelor's degree in Engineering required.
  • Minimum 5 years related experience.
  • Must have experience, or training, and demonstrate proficiency in engineering disciplines (e.g. computer aided design, total quality management (6Sigma), statistical methods, materials science, design of experiments, software development, engineering materials) and metrology.
  • Validation experience is preferred

  • Successful track record of managing activities and cross-functional teams within the business unit.
  • Recognized as a technical expert by peers and other personnel within the business unit.
  • Ability to influence and direct management on courses of action with minimal assistance using both written and verbal methods.
  • Must be able to provide solutions that reflect understanding of business objectives and cost implications.
  • Knowledge of cGMPs, FDA guidelines, Quality Operations, Quality Systems, Procurement practices, and Equipment/Process validation.
  • Must be self-motivated, have good interpersonal skills, capable of analyzing and solving complex problems through innovative thought and experience.
  • Has demonstrated basic leadership skills.
  • Ability to set strategic direction for an organization and represent the engineering function on the sites senior leadership team.
  • Working knowledge of lean manufacturing techniques and lean ergonomics is desired.
  • Regular attendance is necessary to perform the essential functions of the job.
  • Proficient in relevant products or process development processes.
  • Display a basic understanding of theories/practices utilized by other disciplines outside primary area of expertise.
  • Must possess knowledge of related disciplines.
  • Light work, frequent lifting up to 25 lbs; frequent standing/walking
target pay: 40-48
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