Manufacturing Engineer/Project Coordinator

4 hours ago

San Diego, California, United States MILLENNIUMSOFT Full time
Job Summary:

The Manufacturing Engineer/Project Coordinator is responsible for managing quality investigation and process improvement projects within the Dye Production Team. This role requires a strong background in project management, quality assurance, and process improvement. The successful candidate will have experience with project management in a life science industry and be able to work effectively in a cross-functional team environment.

Key Responsibilities:

Manage and direct all phases of a project from project proposal and initiation through completion.

Create and maintain project data and documents such as project dashboard, plans/schedule, quality records and communications.

Act as the driving force for all projects (including customer complaints), coordinating the interactions between Production, QC, Sustaining, R&D and QA to ensure on time execution to the project, identify and work through barriers that hinder progress.

Continuously assesses risk in project plans and seeks to minimize that risk, particularly where timelines and/or budget may be impacted (e.g. resources, regulatory requirements, materials, etc).

Obtain and compile necessary data in response to dye performance related customer complaints, out of trend production materials or product failures and CAPA initiation assessments.

May lead or participate in CAPA investigations to manage data and timelines.

Conducts routine meetings with subject matter experts to discuss open issues/action items and improvements to processes.

Coordinates data, prepares slides and facilitates routine project update meetings to management and key stakeholders.

Participates in and may lead change management activities associated with process improvement or CAPA implementation.

Engages leadership and stakeholders to obtain support and buy in for changes.

Partners with management, project leaders, and process owners to align process improvement initiatives with business objectives.

May conduct cost savings analysis or cost impact to process changes.

Coordinate and carry out necessary documentation, training, qualification and validation activities to support new or modified process changes or deviations.

Utilize Six Sigma principles (DMAIC approach, SIPOC, Process Capability, Root Cause Analysis, Normal and Non-Normal data Statistical Analysis, Failure Modes and Effects Analysis, Design of Experiments) to analyze data.

Provide project management and Six Sigma coaching, training and support to team members.

Other responsibilities or projects as assigned by reporting manager.

Requirements:

B.S. Degree in Chemistry, Engineering or Life Science in with 5+ years relevant industry experience.

Demonstrated experience managing cross-functional projects, minimum 3 years.

Experience with quality systems and guidelines such as GLP and GMP processes and ISO standards essential.

Proficiency in MS Office Suite (Word, Excel, Visio and PowerPoint) is required.

Experience with Minitab or statistical software preferred.

Experience with CAPA investigation procedures is preferred.

PMP certificate is preferred.

Experience in designing dashboard, metrics, etc. is highly desirable (Quick Base experience a plus).

Certification in Six Sigma methodologies and Lean principles is highly desirable.

Strong interpersonal communication skills, effective written and oral communications skills.

Ability to relate to a variety of people and establish collaborative relationships.

Comfortable working in a matrix environment.

Strong prioritizing and multi-tasking skills to work within deadlines.

Must possess meticulous organizational skills, great attention to detail, and have a high aptitude for technology and financial systems.

Strong desire to work within a dynamic, fast-paced environment with the expectations of the role consistently expanding or changing.

Be a self-starter, quick learner with the ability to work independently and efficiently.

Company Overview:

MILLENNIUMSOFT is a leading provider of innovative solutions for the life science industry. Our team is dedicated to delivering high-quality products and services that meet the evolving needs of our customers. We are committed to fostering a collaborative and inclusive work environment that encourages innovation, creativity, and growth. If you are a motivated and experienced professional looking for a new challenge, we encourage you to apply for this exciting opportunity.

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