Engineer 2

Position Details:

Our client, a world-leading Pharmaceutical Company in Santa Clara, CA is currently looking for a Equipment Quality Engineer to join their expanding team.

Job Title: Equipment Quality Engineer / Medical Devices

Duration: 6 months contract, extendable up to 24 months

Location: Santa Clara, CA

Note:

The client has the right-to-hire you as a permanent employee at any time during or after the end of the contract.

You may participate in the company group medical insurance plan

Job Description:

The Equipment Calibration and PM Engineer will support the equipment maintenance and calibration programs at the Redwood City, Santa Clara, and San Jose site.

He or she will ensure compliance of these programs, provide investigation and nonconformance support and drive continuous improvement efforts. The position acts as a technical advisor on all equipment issues.

Additional responsibilities may include performing process improvement projects. This position reports to the Equipment calibration and PM Manager.

Duties and Responsibilities

Works directly with customers, engineering, manufacturing and other groups to develop appropriate equipment

specifications for calibration and preventative maintenance (PM), such as parameters, intervals, tolerances, acceptance

criteria, and operating limits for new and existing equipment and systems.

Review all equipment specifications and records information for completeness and appropriateness.

Provides communication, direction, mentoring, training, and guidance for employees.

Review and approval of Calibration, PM, documents and reports.

Manages service providers to ensure scheduling in accordance with Cal and PM due dates; coordinates the testing,

monitoring, and inspecting processes of equipment calibration and PM

Collect, report, and maintain calibration and preventive maintenance performance data into Computerized Maintenance

Management System (CMMS).

Collaborates with multi-functional groups to resolve calibration/maintenance issues, support non-conformance

investigations, improve equipment reliability, review procedures, and minimize equipment downtime.

Participates in product, project, and process development teams to provide quality support and mentorship.

Supports all audits.

Other related duties may be assigned

Qualifications

Bachelor's Degree in Engineering or technical certifications in a related field is required.

Required Skills and Experience:

Minimum 2 years of proven performance ability working as an Equipment Engineer or Sr. Equipment Technician in a

high-volume manufacturing environment

Experience in review & approval of specification of Calibration, Maintenance, and qualification documentation

Able to analyze data, compile reports, and recommend corrective action

Basic knowledge in the areas of Design Controls Processes, Equipment Validation, Manufacturing practices/principles,

and statistical techniques

Outstanding organization, communication, presentation, and interpersonal skills working within the organization

Able to work independently, efficiently, and collaboratively with all levels of employees and management

Flexibility to support changing assignments and priorities in an independent and reliable manner while maintaining a

positive and collaborative demeanor

Ability to travel and work at local sites (e.g. Redwood City, Santa Clara, and San Jose)

Preferred Skills and Experience:

Experience working in the medical device field

Certified ISO 9001/13485

Experience with computerized management systems, such as SAP and CERDAAC or equivalent

Solid understanding of 21 CFR 820, cGMP, GXP and good documentation practices

Efficiency with Microsoft Office Products such as Word and Excel or equivalent software application