Senior Process Engineer

ALGOBRAINZ LLC; United States; Remote; USD 90,000 - 140,000; Full time

Job summary

ALGOBRAINZ LLC is seeking a Senior Process Engineer to join its pharmaceutical manufacturing team in a remote capacity. The role focuses on supporting, optimizing, and improving processes to ensure safe, efficient, compliant production, collaborating with QA, QC, Engineering, Validation, and R&D to drive continuous improvement.

The ideal candidate has 2+ years of experience in pharmaceutical processing, a solid GMP background, and a degree in Chemical, Pharmaceutical, or Biochemical Engineering.

Qualifications

• 2+ years of experience in pharmaceutical manufacturing.
• Strong knowledge of GMP requirements and process validation.
• Experience with tech transfer, scale-up and process optimization.
• Bachelor’s or Master’s degree in Chemical/Pharmaceutical/Biochemical Engineering or related field.

Responsibilities

• Develop, optimize, and monitor pharmaceutical manufacturing processes for quality and efficiency.
• Participate in process optimization, scale-up, technology transfer, and validation.
• Support investigations, deviations, CAPA, change controls, and root-cause analysis.
• Identify CI initiatives to improve productivity, yield, cycle time, capacity, and cost.
• Prepare and review SOPs, batch records, process descriptions, protocols, and reports.
• Collaborate with QA to ensure GMP and regulatory compliance.
• Support equipment qualification, cleaning validation, process validation, and other validations.
• Monitor CPPs and CQAs; support process control strategies.
• Conduct risk assessments such as FMEA and determine controls.
• Promote safety, quality, compliance, and continuous improvement culture.

Skills

Process optimization

Scale-up

Technology transfer

Process validation

FMEA

GMP compliance

Education

Bachelor’s or Master’s degree in Chemical Engineering/Pharmaceutical Engineering/Biochemical Engineering

Tools

Documentation systems

Job description

Title: Senior Process Engineer – Pharmaceutical Industry

Location: Remote

Experience: 2+ years

Job Summary

We are looking for a motivated and detail-oriented Senior Process Engineer to join our pharmaceutical manufacturing team. The ideal candidate will be responsible for supporting, optimizing, and improving manufacturing processes to ensure safe, efficient, compliant, and consistent production. The role involves working closely with Manufacturing, Quality Assurance, Quality Control, Engineering, Validation, and R&D teams to improve process performance, troubleshoot manufacturing issues, and implement continuous improvement initiatives in accordance with GMP and regulatory requirements.

• Develop, optimize, and monitor pharmaceutical manufacturing processes to achieve consistent product quality and process efficiency.
• Participate in process optimization, scale-up, technology transfer, and process validation activities.
• Support manufacturing investigations, deviations, CAPA, change controls, and root-cause analysis related to process performance.
• Identify and implement Continuous Improvement (CI) initiatives to improve productivity, yield, cycle time, capacity, and cost efficiency.
• Prepare and review process-related documents, including SOPs, batch manufacturing records, process descriptions, protocols, reports, and technical documents.
• Work closely with QA to ensure processes and documentation comply with GMP, SOPs, and applicable regulatory requirements.
• Support equipment qualification, cleaning validation, process validation, and other validation activities as required.
• Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) and support process control strategies.
• Conduct risk assessments such as FMEA and identify appropriate process controls and mitigation measures.
• Promote a strong culture of safety, quality, compliance, and continuous improvement within manufacturing operations.

Requirements

• Strong understanding of pharmaceutical manufacturing processes and GMP requirements.
• Knowledge of process validation, technology transfer, scale-up, and process optimization.
• Bachelor’s or Master’s degree in Chemical Engineering, Pharmaceutical Engineering, Biochemical Engineering, or a related field.