Senior Project Engineer

Primary Talent Partners; West Point (PA); Hybrid; USD 200,579,000 - 229,233,000; Full time

Benefits offered by this job

ACA-compliant supplemental package

Job summary

Primary Talent Partners has a new contract opening for a Senior Project Engineer to join our pharmaceutical client in West Point, PA. This is a 12-month contract to start with potential extensions.

The role requires 6+ years of GMP experience, sterile drug product filling, and strong change-control skills. Remote and hybrid options are available, with West Point onsite a few days per week.

Qualifications

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology.
• 6+ years post-bachelor GMP experience in related areas (Operations/Tech Ops/Technology/Engineering).
• 3+ years sterile/aseptic drug product filling experience.
• Experience with change control processes.
• Strong communication and teamwork skills.
• Ability to manage projects to schedule/deadlines.
• Travel up to 25% (NC/Indiana).

Responsibilities

• Author, review, and maintain GMP documentation with accuracy and compliance.
• Lead change control ownership and execution.
• Prepare protocols and technical reports.
• Support CPV plans, data sets, and trend analyses.
• Perform SPC and data extraction/analysis.
• Create visualizations and summary metrics for outputs.
• Contribute to continuous improvement initiatives and documentation standardization.
• Provide floor support at External Partner site as needed.

Skills

GMP experience

Statistical data analysis

Change control

Sterile/aseptic operations

Project management

Communication & teamwork

Schedule management

Travel readiness

Education

Bachelor's degree in Chemical/Biochemical Engineering or related

Job description

Primary Talent Partners has a new contract opening for a Senior Project Engineer to join our pharmaceutical client in West Point, PA. This is a 12-month contract to start with the potential for extensions.

Pay: $70.00 - $80.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

Description

• 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

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

• Client 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 (1-2 days) 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.

Qualifications

• 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.

Primary Talent Partners is an Equal Opportunity / Aff…? All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

#PTPJobs