Senior Process Engineer - GMP/Pharma Plant Projects

Trinity Consultants - Advent Engineering; San Francisco (CA); On-site; USD 90,000 - 120,000; Full time

Job summary

A leading engineering consultancy in San Francisco is seeking a Process Engineer to support project implementation and quality assurance in a cGMP environment. The ideal candidate will have over 7 years of relevant experience, with a strong background in pharmaceutical manufacturing and regulatory compliance. This role encompasses risk management, leading project charters, and collaboration with cross-functional teams to ensure safety and compliance during commissioning and validation activities.

Qualifications

• 7+ years of relevant work experience in operations/manufacturing environment.
• 5+ years of engineering experience in pharmaceutical/biotech manufacturing.
• Direct experience in regulated environments (FDA, OSHA, EPA).
• Experience implementing risk-based verification for GMP process equipment.
• Demonstrated strong communication and technical writing skills.

Responsibilities

• Work with cross-functional teams for project scope and budget.
• Lead implementation of engineering improvements.
• Develop project charters and strategies.
• Identify risks and develop mitigation countermeasures.
• Ensure validation protocols are executed according to cGMP practices.

Skills

Process equipment knowledge

Process automation knowledge

Strong communication skills

Collaboration skills

Risk-based verification

Process improvement methodologies

Education

Bachelor's degree in engineering or science-related field

Tools

Delta V

Rockwell

Plant Information Systems

Job description

A leading engineering consultancy in San Francisco is seeking a Process Engineer to support project implementation and quality assurance in a cGMP environment. The ideal candidate will have over 7 years of relevant experience, with a strong background in pharmaceutical manufacturing and regulatory compliance. This role encompasses risk management, leading project charters, and collaboration with cross-functional teams to ensure safety and compliance during commissioning and validation activities.