Manufacturing Process Engineer

3 weeks ago

Carlsbad, United States Niktor Full time

Job Title: Manufacturing Process Engineer

Duration: 12 Months

Location: Carlsbad, CA, 92008

Hours: It is 40 hrs/week, 1st shift. Actual start time is a bit flexible within the 1st shift once trained.

Mon-Fri 8am-5pm

Pay Rate: $37.00 - Hourly

Job Description:

Yes, this is onsite in CBD.

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing productivity in their laboratories, we are here to support them.

Location / Division:

5781 Van Allen Way, Carlsbad, CA 92008

Biosciences Division

How will you make an impact?

The Manufacturing Process Engineer is a critical component for maintaining our Quality Management System and driving improvements through projects. This individual will have the ability drive resolutions to day-to-day quality issues and lead projects.

What will you do?

The successful candidate will demonstrate strong organizational and communication skills as well as provide key examples of project management and process improvement experience. The Manufacturing Process Engineer is responsible for leading the day-to-day quality issues within manufacturing and supporting process improvements that may require capital investment. The primary responsibilities are as follows:

Optimize existing products and processes to improve efficiency and product quality within manufacturing and QC workstreams.

Design, develop, and recommend engineering solutions to address capacity, cost, and quality issues.

Define and document specifications by implementing industry standards and best practices to meet product, process and customer requirements and improve overall manufacturing performance.

Drive Practical Process Improvements (PPI) with cross-functional teams by applying lean methodologies (including data analysis and statistical techniques/tools) to improve process efficiency.

Prepare/present reports and data analysis to peers, supervisors, and other internal customers.

Update manufacturing records (e.g. WINs, SOPs, and batch records) to address production issues, improve quality, and implement best practices.

Coordinate validation activities of instruments and equipment used by the manufacturing and QC teams.

Drive safety improvements to promote a safe working environment.

Create and review project proposals and plans with partners and stakeholders.

Manage project cost, documentation and timelines to ensure on-time completion of key deliverables.

Effectively communicate barriers or issues and obtain needed support for a resolution.

Work within our Quality Management System to effectively perform investigations and identify resolutions related to process failures and deviations.

Participate in internal and external audits and respond to audit observations

Identify and implement appropriate corrective and preventative actions.

Collaborate with internal and external vendor for scheduling preventative maintenance and repairs of equipment

Qualifications

Education / Experience:

Bachelor’s degree in sciences and or Engineering (required) (preferred: Mechanical, Electrical, Biomedical, or Industrial Engineering degree)

2+ years of experience in manufacturing environment or similar

1+ years of experience in ISO or cGMP regulated manufacturing environment

Experience with an ERP system and a basic understanding of cost accounting and standard manufacturing financials

Experience with Process Improvement systems and tools (or similar Continuous Improvement and Lean Systems, i.e. Kaizen, Root Cause Counter Measure, etc.)

Demonstrated experience working with cross-functional teams in projects of varying levels

Experience with manufacturing processes and inter-departmental responsibilities

Knowledge / Skills:

Proficient in the use of Microsoft Office Software specifically Excel, Word, and PowerPoint

Familiar with statistical methods (e.g. ANOVA, t-test, normality) and statistical tools/programs (e.g. JMP, Minitab)

Strong collaborative skills and the ability to influence others without formal authority

Excellent oral and written communication skills

Is energized working in a fast-paced environment

Consistent, diligent, and accurate in carrying out responsibilities

Displays positive demeanor toward job and others

Result oriented and data-driven

Understands manufacturing operational flow which includes but not limited to Formulations, Filling and Assembly/Packaging

Has strong project management skills

Proactive approach that anticipates needs and problems while creating solutions

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