Description OverviewThe Process Engineer provides technical and scientific support for commercial prescription (Rx), over-the-counter (OTC), and cosmetic topical products. This role collaborates closely with Regulatory Affairs, Quality, Research & Development, Operations, and Legal teams to develop, optimize, transfer, and validate manufacturing processes. The Process Engineer is responsible for supporting product scale-up activities, evaluating manufacturing and product performance, investigating deviations and product failures, and implementing effective corrective and preventive actions to ensure product quality, compliance, and operational excellence.
The salary range for this role starts at $95,000-$120,000
Scope of the Role- Conduct technical assessments and provide ongoing process support for commercial Rx, OTC, and cosmetic topical products to ensure quality, efficiency, and compliance.
- Lead technology transfer activities for newly developed products and transferred manufacturing processes from R&D or external manufacturing sites into commercial operations, ensuring successful scale-up and implementation.
- Develop, optimize, and implement manufacturing processes for new, existing, reformulated, and transferred products to improve process robustness, efficiency, and product quality.
- Investigate manufacturing issues, process deviations, and product failures; perform root cause analyses and recommend corrective and preventive actions (CAPAs).
- Review, revise, and maintain Manufacturing Orders, Ingredient Disclosures, Excipient Threshold Limits, cleaning procedures, and associated documentation to support regulatory compliance and continuous improvement initiatives.
- Perform laboratory-scale formulation and process development studies to support process optimization, troubleshooting, and scale-up activities.
- Evaluate process performance data and identify opportunities for process improvements, cost reduction, and increased manufacturing efficiency.
- Support Material Review Board (MRB) activities, including the review and disposition of nonconforming materials and products.
- Participate in Process Excellence Management (PEM), Process Performance Qualification (PPQ), Continued Process Verification/Validation (CPV/CV), and other validation activities to ensure processes remain in a state of control.
- Collaborate closely with Regulatory Affairs, Quality Assurance, Research & Development, Operations, and Legal teams to support product lifecycle management and maintain compliance with cGMP and FDA requirements.
- Prepare technical reports, protocols, investigations, and supporting documentation required for process changes, validation activities, and regulatory submissions.
- Manage multiple projects simultaneously while meeting established timelines and business objectives.
Experience Required- Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering, Pharmaceutical Engineering, Chemistry, or a related scientific discipline.
- 2-5 years of pharmaceutical manufacturing, process engineering, technical services, or process support experience in a regulated environment.
- Strong understanding of pharmaceutical manufacturing processes, pharmaceutical sciences, and process engineering principles.
- Knowledge of cGMP requirements, FDA regulations, and pharmaceutical quality systems.
- Excellent interpersonal, organizational, and communication skills, with the ability to collaborate effectively across all levels of the organization.
- Strong technical writing, documentation, and problem-solving skills.
- Ability to independently manage multiple projects and priorities while meeting established timelines.
- Hands-on experience with laboratory-scale manufacturing equipment and a solid understanding of commercial-scale pharmaceutical processing equipment.
- Proficiency with Microsoft Office applications, including Excel, Word, PowerPoint, and OneNote; experience with SAP is preferred.
Preferred Qualifications- Experience with the development, scale-up, optimization, and/or reformulation of topical pharmaceutical or cosmetic products.
- Knowledge of technology transfer, process validation, and continuous improvement methodologies.
BenefitsWe believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
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hereApplicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.)
All application materials, including resumes and CVs, must be submitted in English. Thank you.
