Process Engineer
Company: Quality Agents
Location: Rockville
Posted on: February 10, 2026
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Job Description:
Job Description Job Description Salary: Quality Agents, LLC
offers validation and quality expertise to the pharmaceutical and
biotechnology industries. We are seeking a detail-oriented and
collaborative Process Engineer to support manufacturing and
technical operations in a dynamic biotech environment. This role
plays a key part in optimizing existing processes, implementing new
technologies, and ensuring consistent, compliant production of
clinical and commercial biologics. The ideal candidate brings
hands-on experience in biotech or pharmaceutical process
engineering, with a focus on upstream, downstream or cell therapy
operations. Key Responsibilities Support the design, scale-up,
optimization, and validation of biopharmaceutical manufacturing
processes. Assist in tech transfer activities for new products or
process changes. Develop and revise process documentation including
batch records, SOPs, and protocols. Investigate and troubleshoot
process deviations, equipment issues, and production challenges.
Analyze process data and identify opportunities for improvement in
yield, efficiency, or quality. Collaborate cross-functionally with
QA, QC, Manufacturing, and Engineering teams. Support
commissioning, qualification (IQ/OQ/PQ), and validation activities
for equipment and systems. Ensure all work aligns with GMP and
regulatory requirements. Minimum Requirements: B.S. or M.S. in
Chemical Engineering, Biochemical Engineering, or related field. 3
years of experience in a biotech, pharmaceutical, or GMP-regulated
environment. Familiarity with upstream (cell culture/fermentation)
or downstream (purification) processes. Experience with process
monitoring, root cause analysis, and continuous improvement
initiatives. Working knowledge of industry guidelines (GMP, ICH,
FDA). Strong communication, organization, and problem-solving
skills. Quality Agents offers a full suite of benefits for
full-time employees including: Health, dental and vision insurance
Life, AD&D and Disability Insurance Health savings account for
participants in our health plan 401k retirement plan Paid time off
Paid holidays Quality Agents accepts applications on an on-going
basis in order to build a talent pool of potential candidates.
These applications remain open for consideration, as positions
become available, for one (1) year from the date of application.
After that time, or if your application information changes, please
submit your application again.
Keywords: Quality Agents, Olney , Process Engineer, Science, Research & Development , Rockville, Maryland
