Project Engineer - III (Senior)

Client is seeking a highly motivated individual for a technical operations contractor position.

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.)
Prior experience and competency with change control
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%(NC/Indiana)
Preferred Experience and Skills:
Experience with isolator filling.

Key Skills:

• ** External Manufacturing Technical Operations Contractor role supporting Drug Product operations.

The assignment is planned for one year, with a possible one-year extension.
Both remote and hybrid options available. The role can be remote, but West Point is the preferred location; local candidates may be expected to come onsite a few days(1-2days) per week.
The ideal candidate should have around 6+ years of experience and strong technical operations experience in sterile liquids, injectables, vials, and syringes—not solid dosage.
Key skills include change control ownership/execution, organization, planning, statistical understanding, cross-functional communication, teamwork, and ability to work independently.
The role will involve process-related technical change controls across multiple sites, including work with SOPs, procedures, systems, emails, meetings, and stakeholder coordination.
Travel will be up to 25%, mainly to North Carolina and Indiana.
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.
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 and execution
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