Process Engineer II

DSJ Global; Houston (TX); On-site; USD 90,000 - 106,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking a highly motivated Process Engineer II to enhance production processes. The ideal candidate will have a strong background in cGMP environments and expertise in chemical or biochemical engineering. Responsibilities include optimizing manufacturing processes and ensuring compliance with regulatory standards.

Qualifications

• Minimum of 5 years of experience in pharmaceutical manufacturing.
• Strong knowledge of aseptic filling equipment and processes.
• Experience with filtration, chromatography, lyophilization, or aseptic processing.

Responsibilities

• Design, implement, and optimize processes for drug manufacturing.
• Monitor and analyze process performance metrics.
• Ensure compliance with FDA, EMA, and ICH guidelines.

Skills

Problem-solving

Communication

Teamwork

Education

Bachelor's degree in Chemical, Mechanical, or Biomedical Engineering

Tools

JMP

Minitab

Job description

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Base pay range

$90,000.00/yr - $106,000.00/yr

Direct message the job poster from DSJ Global

We are seeking a highly motivated Process Engineer II to support the design, implementation, optimization, and scale-up of pharmaceutical manufacturing processes. This role is critical in ensuring that production processes meet quality, safety, and regulatory requirements while achieving operational efficiency. The ideal candidate will have experience in cGMP environments and a solid background in chemical or biochemical process engineering.

Key Responsibilities:

Design, implement, and optimize processes for drug substance and/or drug product manufacturing.

• Provides technical expertise in aseptic filling and lyophilization by troubleshooting process issues, optimizing performance, and developing robust lyophilization cycles.

Support tech transfer of new products from R&D to manufacturing.

Lead or assist in process scale-up, validation, and troubleshooting efforts.

Author and review documentation such as batch records, protocols (IQ/OQ/PQ), and technical reports.

Monitor and analyze process performance metrics to identify trends, deviations, and opportunities for improvement.

Collaborate with cross-functional teams including Quality, Manufacturing, R&D, and Regulatory Affairs.

Ensure compliance with FDA, EMA, ICH guidelines, and company policies.

Support investigations (e.g., deviations, CAPAs) and contribute to root cause analysis.

Evaluate and implement new technologies or equipment to improve process robustness and efficiency.

Qualifications:

Bachelor's degree in Chemical, Mechanical, or Biomedical Engineering, Pharmaceutical Sciences, or a related field

Minimum of 5 years of experience in pharmaceutical manufacturing, with strong knowledge of aseptic filling equipment and processes, including vial washers, depyrogenation tunnels, filling machines, and lyophilizers

Strong understanding of cGMP regulations and pharmaceutical process validation

Experience with unit operations such as filtration, chromatography, lyophilization, or aseptic processing

Proficiency in process modeling and statistical analysis tools (e.g., JMP, Minitab)

Excellent problem-solving, communication, and teamwork skills

Ability to work in a fast-paced, dynamic environment with minimal supervision

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Industries

  Pharmaceutical Manufacturing

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