Process Engineer – MS&T
Location: Middletown
Focus: Oral Solid Dosage (OSD) Manufacturing
Position Overview
We are seeking an experienced Process Engineer to support pharmaceutical manufacturing operations, with an initial focus on Oral Solid Dosage (OSD). This role will lead technology transfers, new product introductions (NPI), process validation, and commercial manufacturing support. The Process Engineer will serve as a technical subject matter expert, ensuring manufacturing processes are efficient, compliant, and scalable.
Key Responsibilities
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Lead technology transfers and new product introductions, supporting successful commercialization.
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Develop and execute process and cleaning validation activities, including PPQ and Continued Process Verification (CPV).
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Provide technical support for commercial manufacturing, troubleshooting, and process improvements.
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Investigate manufacturing deviations, perform root cause analysis, and implement CAPAs.
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Support OSD manufacturing processes, including blending, granulation, compression, encapsulation, coating, and packaging.
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Lead cross-functional projects involving Manufacturing, Quality, Engineering, and Regulatory teams.
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Ensure compliance with cGMP, FDA, EMA, and ICH requirements.
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Support change controls, regulatory submissions, audits, and inspections.
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Potentially support sterile manufacturing operations as site capabilities expand.
Required Qualifications
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Bachelor's degree with 8+ years or Master's degree with 6+ years of pharmaceutical manufacturing experience.
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Strong experience in Oral Solid Dosage (OSD) manufacturing.
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Hands-on experience with technology transfer, NPI, process validation, and PPQ.
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Experience supporting commercial manufacturing, troubleshooting, and process optimization.
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Strong understanding of cGMP regulations and pharmaceutical manufacturing processes.
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Proven ability to lead technical projects and cross-functional teams.
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Excellent communication, technical writing, and problem-solving skills.
Preferred Qualifications
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Experience working in a CDMO environment.
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Experience with commercial product launches and customer-facing technical support.
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Knowledge of sterile manufacturing, aseptic processing, or sterile process validation.
Ideal Candidate: A hands-on pharmaceutical Process Engineer with strong OSD manufacturing experience, demonstrated success leading technology transfers and validation activities, and the ability to support commercial manufacturing operations.
Sterile manufacturing experience is a plus but not re