Process Engineer

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.