Process Engineer

Job Description

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.

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

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Title: Process Engineer (MSAT)

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Location Raritan, NJ

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Onsite (Mon-Fri, 40 hours)

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Contract Duration: 12 months, with likely extension

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Pay Rate: $51.48 per hour (w2)

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Position Overview

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

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global implementation of dual sourcing strategies for lentiviral materials as part

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

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help strengthen manufacturing reliability, innovation, sustainability, and

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process robustness across global sites and manufacturing operations. The

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

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manufacturing organizations, suppliers, and external partners to successfully

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execute critical material and process initiatives.

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The ideal candidate brings strong project management capabilities, technical

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

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a complex global matrix environment. Experience with viral manufacturing,

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

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desirable.

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Key Responsibilities

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Lead process improvement initiatives focused on the dual sourcing of

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materials used in lentiviral manufacturing to improve reliability, resiliency,

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process performance, and operational effectiveness.

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Develop and manage detailed project plans for dual sourcing initiatives

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

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risks, and cross functional dependencies.

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Lead activities related to vendor and material identification, including

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identifying materials for dual sourcing, developing User Requirements

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Specifications, reviewing and approving vendor drawings, conducting

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formal comparability assessments, defining material quality attributes,

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and creating and implementing change controls.

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Support the development and implementation of standard processes for

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supply chain management, logistics, and distribution to improve

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operational effectiveness.

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Partner with production and manufacturing teams to optimize resources,

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improve manufacturing performance, reduce costs, and strengthen

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process robustness.

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Drive organizational change through effective project management,

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stakeholder engagement, and communication strategies.

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Coordinate team activities, delegate responsibilities, and provide clear

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direction to support successful project execution.

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Monitor and analyze manufacturing performance and identify

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opportunities for process improvement, cost reduction, increased

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reliability, and operational excellence.

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Conduct risk assessments and develop mitigation strategies to address

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technical, operational, and project risks.

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Create clear visuals, analytics, and project reporting to communicate

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

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schedules.

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Collaboration and Communication

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Collaborate with local and global stakeholders across MSAT,

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

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leadership organizations.

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Represent Site MSAT in internal and external meetings and communicate

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manufacturing requirements, technical considerations, project status, and

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key insights.

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Build effective relationships with internal and external partners and

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facilitate alignment across a global organization.

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Required Qualifications

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

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or a related scientific or engineering discipline.

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Approximately 5 years of experience in the pharmaceutical or

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biotechnology industry.

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At least 3 years of project management experience.

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Strong knowledge of biological manufacturing processes, including

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upstream and downstream processing.

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Working knowledge of material specifications, User Requirements

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Specifications, comparability assessments, and change control processes.

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In depth knowledge of cGMP guidelines and Health Authority regulations,

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including FDA and EMA requirements.

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Demonstrated proficiency with Microsoft Project.

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Strong proficiency with Microsoft PowerPoint and Excel.

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Excellent written and verbal communication skills.

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Ability to independently solve complex technical and operational

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challenges and work effectively in a cross functional team environment.

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Preferred Qualifications

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Experience with lentiviral vectors, viral manufacturing, cellular therapies,

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advanced therapies, or related biologics manufacturing.

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Experience working within a global matrix organization.

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Professional project management certification such as PMP or CPM.

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Fluent written and spoken English.

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