Position : Manufacturing Engineer/Project Coordinator
Location : San Diego, CA
Duration : 12 Months contract
Total Hours/week : 40.00
Work hours: Standard 8-hr shift; 8-5 pm (including lunch)
3 Must haves on the resume:
- Six sigma experience
- cross-functional project management
- 5+ industry experience (including ISO, GMP, or GLP)
- The Manufacturing Engineer/Project Coordinator is responsible for managing quality investigation and process improvement projects within the Dye Production Team.
- Must be comfortable working with subject matter experts in cross-functional teams under defined deadlines.
- The successful candidate will have experience with project management in a life science industry.
- Client Biosciences, a segment of Company, is one of the world’s leading businesses focused on bringing innovative tools to life science researchers and clinicians.
- Product lines include flow cytometers, cell imaging systems, monoclonal antibodies, research reagents, diagnostic assays, and tools to help grow tissue and cells.
- Client Biosciences is an Equal Opportunity/Affirmative Action Employer.
- Sirigen, Inc. is a subsidiary of client Biosciences and produces polymeric reagents for use in Flow Cytometry and Cell Imaging systems.
Duties & Responsibilities:
- Manages and directs all phases of a project from project proposal and initiation through completion.
- Creates and maintains project data and documents such as project dashboard, plans/schedule, quality records and communications.
- Acts 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).
- Obtains and compiles 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.
- Promotes a safe work environment. Provide recommendations on maintaining the safety of the work environment.
- Participates in Environmental Health and Safety programs.
- Addresses corrective actions whenever a hazard is identified. Notifies supervisor of all observed hazardous conditions or unsafe work
Education & Experience:
- Successful candidate will possess a 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.