Senior Process Engineer
Title : Senior Process Engineer
Location : Santa Clara, CA
Duration : 6+ months of contract with possible extension
About Client :
A prominent force in the realm of pharmaceuticals and diagnostics, this global innovator stands at the forefront of scientific advancement dedicated to enhancing human well-being.
With a unique synergy between pharmaceuticals and diagnostics, it has pioneered personalized healthcare, tailoring treatments to individual patients with precision.
Renowned for its groundbreaking contributions, this entity boasts the largest portfolio in biotechnology, encompassing transformative medications spanning oncology, immunology, infectious diseases, ophthalmology, and disorders of the central nervous system.
Additionally, it leads the world in in vitro diagnostics and tissue-based cancer diagnostics, while also spearheading advancements in diabetes management.
Description : Participates in and leads validations and projects within the manufacturing areas. This engineer is responsible for successful project completion including necessary reports and approvals.
Identifies and assists with implementing improvements around current manufacturing processes with guidance from manager and senior engineers.
Responsibilities also include equipment and process validations as well as process characterization and root cause investigations.
Responsibilities :
- Assess existing processes and equipment and identify and implement improvements.
- Implement new or transferred manufacturing processes in a timely manner.
- Lead and / or participate in equipment and process validations.
- Assist in troubleshooting of process and / or equipment issues.
- Strong written and verbal communication skills.
- With guidance, able to prepare and present technical information and project summaries to peers and management.
- Monitors work to ensure quality and to continuously promote Quality First Time.
- Automation & Factory Support specifics :
- Assist in designing and implementing new equipment and tools to improve manufacturing efficiencies, reduce ergonomic stress, and improve quality.
- Update, create and sustain Standard Work documents.
- Create and update drawings using Pro / Engineer or SolidWorks.
- Work as part of a project team in the development and / or implementation of new equipment and tools.
- Technical support for daily production issues related to manufacturing equipment.
Quality Support specifics :
- Assist in addressing, owning, and resolving quality-related issues for the manufacturing departments (ex CAPAs, and Audits)
- Consistently uses company concepts, policies, and procedures, familiar with and follows standard practices.
- Executes experiments; participates in experimental design.
- Utilizes DOE where appropriate.
- Analyzes data, evaluates results, forms conclusions and provides / implements process or document improvements.
- May perform other duties as required or assigned.
Education / Experience :
Bachelor's Degree BS degree or equivalent in a directly related discipline
Years of Experience Experience Details
6+ years related experience preferred with the required bachelor’s degree.
MS degree in directly related discipline 4+ years of related experience required.
PhD in directly related discipline and 2+ years’ experience required.
Knowledge, Skills and Abilities :
Must have the ability to manage priorities based on the needs of the manufacturing area with some guidance from the reporting manager and senior management.
Knowledge of biomedical / biotechnology manufacturing.
Demonstrates potential for technical proficiency, engineering creativity, collaboration with others, and independent thought.
Strong understanding of engineering principles and concepts.
Strong computing skills utilizing Microsoft Office tools such as Excel, Word, and PowerPoint.
Strong teamwork skills.
Demonstrated troubleshooting and problem-solving skills including the use of designed experiments.
Ability to meet project deadlines.
Ability to multitask and prioritize with some guidance from management.
Automation & Factory Support specifics :
Experience with automated manufacturing equipment and automation technologies.
Experience with CAD programs such as Pro / Engineer and / or SolidWorks.
Experience in a regulated environment. Knowledge of FDA Quality System Regulations (QSRs) is a plus.
Experience with Lean Systems.
Quality Support specifics :
Experience in reagent or instrument manufacturing for a Medical Device or Pharmaceutical company.
Experience in a regulated environment. Knowledge of FDA Quality System Regulations (QSRs).
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