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MESO SCALE DIAGNOSTICS, LLC. · 1 month ago

Engineer III, Process

Rockville, MD

Full-time

Onsite

Mid, Senior Level

$101K/yr - $155K/yr

6+ years exp

Meso Scale Diagnostics, LLC. is a company that specializes in biochemical assay plates and related consumables. They are seeking an Engineer III, Process to lead the development, characterization, and validation of manufacturing processes, while providing guidance to technical teams and collaborating with other departments to ensure product performance.

Innovation ManagementManufacturingTest and Measurement

No H1B

Responsibilities

Provide input to the management team to identify, develop, and execute departmental initiatives and strategies

Lead technical team(s) to accomplish project goals and manages/coordinates work of other team members

Enhance existing manufacturing processes and implement new manufacturing processes to ensure high quality production, reduced lot-to-lot variability, expanded product portfolio and enhancements to manufacturing capacity

Design, conduct, supervise and review process experiments on manufacturing and pilot scale equipment to determine the impact of material properties and process variables on product properties

Work with suppliers to improve product quality and lot-to-lot reproducibility of purchased raw materials

Collaborate with other departments to ensure peak product performance

Support the corporate validation effort as required for ISO certification and FDA approval

Write and review SOPs, validation protocols and validation reports

Document and present experimental results in accordance with company procedures

Specific duties may vary depending upon departmental requirements

Qualification

Process development techniquesQuality standards GMPQuality standards ISOStatistical analysisScreen printing techniquesAssay development techniquesMS Office SuiteAnalytical skillsLeadership skillsCommunication skillsTeamwork

Required

Bachelor's in chemical/biochemical engineering or a related field

Six to eight years related experience in manufacturing of instrumentation or related field

Experience in quality standards such as GMP, ISO 9001 and ISO 13485 is required

Expert knowledge of process development techniques (such as process optimization, process control, design of experiments) and statistical analysis

Expert knowledge of screen printing, assembly and coating techniques, fluid dispensing, drying/desiccation techniques, protein stabilization, electrochemiluminescence and image analysis techniques

Familiarity with assay development and QC techniques

Attention to detail with demonstrated commitment to excellence and performance

Strong analytical skills with the demonstrated ability to gather and evaluate complex data and information and develop a recommendation and plan of action

Ability to work independently, as an effective team member, and with all levels of the company

Demonstrated ability to move project tasks forward in an orderly and structured fashion

Excellent oral, written communication and interpersonal skills

Proficiency with the MS Office Suite (including MS Project) and Minitab

Demonstrated ability to multi-task and work productively in a demanding research environment with changing priorities

Solid leadership skills with demonstrated knowledge and understanding of staff management practices and processes. Ability to establish accountabilities and expectations and manage performance to achieve results

Ability to travel locally

Preferred

Supervisor experience is preferred

Benefits

Medical, dental, and vision coverage

Prescription benefits

401(k) plan with company matching

Flexible spending accounts

Company-paid short- and long-term disability insurance

Group life and accidental death and dismemberment insurance

Paid vacation

Paid sick leave

Paid holidays

Paid parental leave

Employee assistance program

Fitness club membership contribution

Pet insurance

Identity theft protection

Home and auto insurance discounts

Optional supplemental life insurance

Company

MESO SCALE DIAGNOSTICS, LLC.

Glassdoor3.2

Founded in 1995, Meso Scale Discovery (MSD) is a global leader in the development, manufacture, and commercialization of innovative assays and instruments for the measurement of molecules in biological samples.

Founded in 1995

Rockville, Maryland, USA

1001-5000 employees