Biochemical Manufacturing Engineer I - Process Design

Meso Scale Diagnostics LLC; Rockville (MD); On-site; USD 68,000 - 101,000; Full time

Benefits offered by this job

Medical

Dental

Vision coverage

401(k) plan with company matching

Flexible spending accounts

Disability insurance

Life insurance

Paid vacation

Paid sick leave

Paid holidays

Parental leave

Employee assistance program

Job summary

Meso Scale Diagnostics LLC in Rockville, MD designs, develops, and validates biochemical manufacturing processes, applying FPLC and HPLC techniques to improve product quality and yield within the Manufacturing department. The role focuses on designing equipment configurations, updating SOPs, and collaborating on validation and tech transfer documents for processes using FPLC, HPLC, and related instruments.

You will also train production staff, maintain equipment, and ensure safety and cGMP

Qualifications

• Bachelor's degree in Engineering, Biotechnology, Chemistry, Biology or related field.
• One year of hands‑on experience with FPLC or HPLC is required.

Responsibilities

• Design and test new ways to leverage biochemical principles for manufacturing process improvement initiatives that deliver better quality and/or quantity of products.
• Design equipment and software configuration to suit the product range and the process technologies.
• Assist with the implementation of updated standard operating procedures.
• Collaborate on equipment and software validation documents, and coordinate validation efforts.
• Collaborate on draft documents for technical transfer of new processes utilizing FPLC, HPLC, and/or other specialized instruments operated by the Biochemical Manufacturing team.
• Troubleshoot equipment including but not limited to FPLC and HPLC;
• Document troubleshooting steps and preventative measures to better streamline production processes.
• Collaborate with other specialists to ensure the efficient running of production facilities.
• Assist with technical training of manufacturing team members for new and updated processes.
• Ensure that potential safety issues related to environment and equipment are considered at all stages.
• Maintain preventative maintenance schedules for specialized lab equipment.
• Purify protein solutions via FPLC to prepare conjugation or coating solutions.
• Utilize HPLC to perform size exclusion chromatography analysis on customer samples in order to report percentages of monomer, aggregation, and free-tag.

Skills

FPLC

HPLC

Akta systems

Analytical concepts

cGMP knowledge

MS Office

Education

Bachelor's degree in Engineering

Tools

FPLC systems

HPLC systems

Akta software

Job description

Meso Scale Diagnostics LLC in Rockville, MD designs, develops, and validates biochemical manufacturing processes, applying FPLC and HPLC techniques to improve product quality and yield within the Manufacturing department. The role focuses on designing equipment configurations, updating SOPs, and collaborating on validation and tech transfer documents for processes using FPLC, HPLC, and related instruments.

You will also train production staff, maintain equipment, and ensure safety and cGMP