Senior Process Engineer

Meet Life Sciences; Charleston (SC); On-site; USD 110,000 - 150,000; Full time

Job summary

Meet Life Sciences in Charleston, SC, is seeking a Senior Process Engineer to provide technical support for clinical and commercial sterile/parenteral drug product manufacturing. The role emphasizes process tech transfer, validation, troubleshooting, investigations, and manufacturing documentation in a cGMP-regulated environment.

You will lead tech transfers and CAPA activities, author Master Batch Records and validation protocols, coordinate lab studies with formulation teams, and ensure

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field.
• 5+ years of technical support experience in sterile pharmaceutical manufacturing.
• Experience with parenteral drug product tech transfers preferred.
• Strong knowledge of cGMP requirements and sterile manufacturing processes.

Responsibilities

• Support process tech transfers, validation activities, and manufacturing projects.
• Author Master Batch Records and process validation documentation.
• Provide technical troubleshooting support during manufacturing operations.
• Lead manufacturing investigations and CAPA activities.
• Develop CQA assessments, pFMEA risk assessments, validation protocols, and sampling plans.
• Coordinate laboratory studies with formulation development teams.
• Partner with internal stakeholders and clients on project activities.
• Ensure compliance with cGMP, FDA, EU, SOP, and batch record requirements.

Skills

Technical writing

Troubleshooting

Analytical skills

Communication skills

Microsoft Office

Education

Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field

Tools

Microsoft Office

Job description

The Senior Process Engineer provides technical support for clinical and commercial sterile/parenteral drug product manufacturing. The role focuses on process tech transfer, validation, troubleshooting, investigations, and manufacturing documentation in a cGMP-regulated environment.

Responsibilities

• Support process tech transfers, validation activities, and manufacturing projects.
• Author Master Batch Records and process validation documentation.
• Provide technical troubleshooting support during manufacturing operations.
• Lead manufacturing investigations and CAPA activities.
• Develop CQA assessments, pFMEA risk assessments, validation protocols, and sampling plans.
• Coordinate laboratory studies with formulation development teams.
• Partner with internal stakeholders and clients on project activities.
• Ensure compliance with cGMP, FDA, EU, SOP, and batch record requirements.

Qualifications

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field.
• 5+ years of technical support experience in sterile pharmaceutical manufacturing.
• Experience with parenteral drug product tech transfers preferred.
• Strong knowledge of cGMP requirements and sterile manufacturing processes.
• Strong technical writing, troubleshooting, analytical, and communication skills.
• Proficiency with Microsoft Office.
• Willingness to work fully on-site and travel up to 5% domestically.