Process Engineer

Source One is a consulting services company and we’re currently looking for the following individual to work as a consultant with our direct client, a global pharmaceutical manufacturing client in Raritan, NJ.

No Third-Party, No Corp to Corp, No Sponsorship Now, Future or Current Temporary Authorization

Title: Process Engineer (MSAT)

Location Raritan, NJ

Onsite (Mon-Fri, 40 hours)

Contract Duration: 12 months, with likely extension

Pay Rate: $51.48 per hour (w2)

Position Overview

We are seeking a Senior Material Excellence Engineer, Site MSAT to lead the

global implementation of dual sourcing strategies for lentiviral materials as part

of Project S.U.R.G.E. (Single Use Resiliency & Growth Evolution). This role will

help strengthen manufacturing reliability, innovation, sustainability, and

process robustness across global sites and manufacturing operations. The

position will work closely with cross functional teams, site and global leadership,

manufacturing organizations, suppliers, and external partners to successfully

execute critical material and process initiatives.

The ideal candidate brings strong project management capabilities, technical

knowledge of biological manufacturing, and the ability to operate effectively in

a complex global matrix environment. Experience with viral manufacturing,

lentiviral vectors, cellular therapies, or other advanced therapies is highly

desirable.

Key Responsibilities

Lead process improvement initiatives focused on the dual sourcing of

materials used in lentiviral manufacturing to improve reliability, resiliency,

process performance, and operational effectiveness.

Develop and manage detailed project plans for dual sourcing initiatives

under Project S.U.R.G.E., including timelines, deliverables, milestones,

risks, and cross functional dependencies.

Lead activities related to vendor and material identification, including

identifying materials for dual sourcing, developing User Requirements

Specifications, reviewing and approving vendor drawings, conducting

formal comparability assessments, defining material quality attributes,

and creating and implementing change controls.

Support the development and implementation of standard processes for

supply chain management, logistics, and distribution to improve

operational effectiveness.

Partner with production and manufacturing teams to optimize resources,

improve manufacturing performance, reduce costs, and strengthen

process robustness.

Drive organizational change through effective project management,

stakeholder engagement, and communication strategies.

Coordinate team activities, delegate responsibilities, and provide clear

direction to support successful project execution.

Monitor and analyze manufacturing performance and identify

opportunities for process improvement, cost reduction, increased

reliability, and operational excellence.

Conduct risk assessments and develop mitigation strategies to address

technical, operational, and project risks.

Create clear visuals, analytics, and project reporting to communicate

critical paths, key handoffs and transitions, milestones, and high level

schedules.

Collaboration and Communication

Collaborate with local and global stakeholders across MSAT,

manufacturing, production, supply chain, quality, project teams, and

leadership organizations.

Represent Site MSAT in internal and external meetings and communicate

manufacturing requirements, technical considerations, project status, and

key insights.

Build effective relationships with internal and external partners and

facilitate alignment across a global organization.

Required Qualifications

Bachelor’s degree in Biochemistry, Biotechnology, Chemical Engineering,

or a related scientific or engineering discipline.

Approximately 5 years of experience in the pharmaceutical or

biotechnology industry.

At least 3 years of project management experience.

Strong knowledge of biological manufacturing processes, including

upstream and downstream processing.

Working knowledge of material specifications, User Requirements

Specifications, comparability assessments, and change control processes.

In depth knowledge of cGMP guidelines and Health Authority regulations,

including FDA and EMA requirements.

Demonstrated proficiency with Microsoft Project.

Strong proficiency with Microsoft PowerPoint and Excel.

Excellent written and verbal communication skills.

Ability to independently solve complex technical and operational

challenges and work effectively in a cross functional team environment.

Preferred Qualifications

Experience with lentiviral vectors, viral manufacturing, cellular therapies,

advanced therapies, or related biologics manufacturing.

Experience working within a global matrix organization.

Professional project management certification such as PMP or CPM.

Fluent written and spoken English.