Process Development Laboratory Engineer

Unicon Pharma Inc; San Mateo (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

Unicon Pharma Inc in Foster City, CA is seeking a Process Development Laboratory Engineer to support laboratory operations, run experiments, and assist with drug product process development, CCI studies, and product compatibility assessments.

You will maintain equipment, assist with qualification and calibration, document results, and contribute to SOPs, inventory management, and continuous improvement in a GDP-regulated environment.

Qualifications

• Bachelor’s degree required in a related field.
• Minimum 4 years hands-on laboratory experience.
• Strong documentation and organizational skills.

Responsibilities

• Execute laboratory experiments, sample preparation, testing, and data collection.
• Operate, maintain, and troubleshoot lab equipment.
• Support equipment installation, qualification, and calibration.
• Maintain GDP-compliant documentation and study records.
• Draft SOPs and forms.
• Manage samples, chemicals, and inventory.
• Drive 5S and workflow improvements.
• Ensure EH&S, quality, and lab requirements.

Skills

Lab operations

Documentation

Data analysis

Multi-tasking

GDP compliance

Education

Bachelor's degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or related field

Tools

Lab equipment operation

Equipment qualification

Job description

Process Development Laboratory Engineer – Job Summary

• Location: Foster City, CA (Onsite, 5 days/week)
• Department: Process Technologies & Development (PT&D)

Role Overview

Support process development laboratory operations, execute experiments, operate and maintain lab equipment, and assist with drug product process development, container closure integrity (CCI), and product compatibility studies.

Key Responsibilities

• Execute laboratory experiments, sample preparation, testing, and data collection.
• Operate, maintain, and troubleshoot lab equipment, including leak detection, microscopy, filling, filtration, and mixing systems.
• Support equipment installation, qualification, and calibration.
• Maintain accurate laboratory documentation, logbooks, and study records following GDP.
• Draft and update SOPs, work instructions, and forms.
• Manage samples, chemicals, and laboratory inventory.
• Drive continuous improvement through 5S, lab organization, and workflow optimization.
• Comply with EH&S, quality, and laboratory requirements.

Required Qualifications

• Bachelor’s degree in Engineering, Chemistry, Biology, Pharmaceutical Sciences, or a related field.
• 4+ years of hands-on laboratory experience.
• Strong documentation, organizational, and multitasking skills.

Preferred Qualifications

• Pharmaceutical or biotech process development experience.
• Knowledge of CCI, extractables/leachables, or fill-finish operations.
• Experience with equipment qualification and laboratory startup.