Pilot GMP Bioprocess Engineer (Cell Culture)

CAMRIS International; Silver Spring (MD); On-site; USD 80,000 - 110,000; Full time

Job summary

CAMRIS International is seeking a Bioprocess Specialist to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role focuses on SOPs, batch records, and cGMP operations across upstream/downstream activities.

You will collaborate with QA, QC, Engineering, and Materials teams to ensure compliant manufacturing and timely documentation, while supporting training and aseptic processing as needed.

Qualifications

• Experience in cGMP manufacturing environments.
• Ability to prepare media, buffers, and single-use assemblies.
• Proficient in documenting and reviewing batch records and QA documentation.
• Strong communication with QA, QC, Engineering, and production teams.

Responsibilities

• Author, revise, and maintain SOPs, batch records, and work instructions.
• Operate and support cGMP equipment qualification activities.
• Execute manufacturing operations per cGMP, GDP, and SOPs.
• Document deviations and issues per site procedures.
• Maintain clean, compliant manufacturing spaces and PPE practices.
• Collaborate with multiple PBF functions to align on schedules and priorities.
• Prepare media, buffers, and components for operations.
• Perform on-floor sampling with cGMP analytical tools.
• Generate run reports and quality documentation per policies.
• Support aseptic manufacturing and fill/finish activities when assigned.
• Train personnel in approved procedures and equipment operation.
• Ensure timely entry of data into product and operation records.

Skills

cGMP knowledge

Good Documentation Practices

SOP development

Data entry accuracy

Cross-functional communication

Tools

UNICORN software

Job description

CAMRIS International is seeking a Bioprocess Specialist to support the Pilot Bioproduction Facility at WRAIR in Silver Spring, MD. The role focuses on SOPs, batch records, and cGMP operations across upstream/downstream activities.

You will collaborate with QA, QC, Engineering, and Materials teams to ensure compliant manufacturing and timely documentation, while supporting training and aseptic processing as needed.