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Project Engineer - III (Senior)

Integrated Resources, Inc

West Point, PA(remote)

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JOB DETAILS
SKILLS
Analysis Skills, Asepsis, Biochemistry, Biology, Biotech and Pharmaceutical, Chemical Engineering, Chemistry, Communication Skills, Continuous Improvement, Data Analysis, Data Processing, Data Sets, Documentation Standards, Drug Products, GMP (Good Manufacturing Practices), Metrics, Process Analysis, Process Control Engineering, Process Improvement, Project Engineering, Project/Program Management, Quality Control, Statistical Process Control, Statistics, Team Player, Technical Operations, Time Management, Trend Analysis, Willing to Travel
LOCATION
West Point, PA(remote)
POSTED
4 days ago
Title: Project Engineer - III (Senior)
Location: REMOTE ROLE WITH 25% TRAVEL EXPECTED at the client s External Partner network sites.
Contract: 12 Months

Job 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

About the Company

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Integrated Resources, Inc

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