Project Engineer - III

Job description: Job Title: Project Engineer III (Remote role) Duration: 12+ Months REMOTE ROLE WITH 25% TRAVEL EXPECTED at the client’s External Partner network sites. Description: Client is seeking a highly motivated individual for a technical operations contractor position. This role will primarily support the commercial manufacture of Drug Product (Form / Fill) at the client’s External Partner network sites inclusive of the responsibilities below. Education Minimum Requirement:

• Bachelor’s degree in Chemical / Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.

Required Experience and Skills:

• Minimum of 6 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering
• Min 3 years of experience supporting sterile / aseptic drug product filling (vials, syringes, etc.)
• Statistics experience
• Strong communication and teamwork skills
• Demonstrated ability to independently manage projects/work to schedule/deadlines
• Travel may be required but not to exceed 25%

Preferred Experience and Skills:

• Experience with isolator filling

Important Note: REMOTE ROLE WITH 25% TRAVEL EXPECTED at the client’s External Partner network sites. Responsibilities include:

• Author, review, and maintain GMP technical documentation with clarity, accuracy, and compliance to applicable regulatory and quality requirements. Documents include:
• Change control ownership
• Protocols and technical reports
• Continued Process Verification (CPV) plans, data sets, trend analyses, and periodic reports
• Perform statistical data extraction and analysis to support proactive process analysis. Typical activities:
• Pull and validate production, quality, and process control data from relevant GMP sources or approved data trending systems
• Apply statistical process control (SPC), capability analysis, and other appropriate methods
• Create visualizations and summary metrics to support assessment outputs
• Contribute to continuous improvement initiatives, including data-driven process optimization and documentation standardization
• Floor support as needed for Person-In-Plant activities at External Partner

Pay: $75.00 - $80.00 per hour Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

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