Process Engineer II

Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience through creativity and invention; delivering our world class Marketing Partners unmatched formulations, innovative packaging and cost effective, reliable supply.

Formulated Solutions is and shall always be a company of people with the knowledge and dedication to provide our Marketing Partners with a single source solution for delivering quality and innovative products to market. We shall embrace changes and new opportunities as a vehicle to continually develop and grow sustainable relationships. As a company we shall never accept anything less than a culture that fosters creativity, growth, and profitability for both our Partners and the company.

Provide technical and process engineering support for pharmaceutical and OTC manufacturing operations throughout the product lifecycle, including process development, scale-up, technology transfer, process validation, commercial manufacturing support, equipment qualification, and continuous improvement initiatives. This position serves as a key technical resource for manufacturing operations and requires demonstrated experience operating within a cGMP-regulated pharmaceutical manufacturing environment.

• Provide day-to-day technical support for pharmaceutical and OTC manufacturing operations to ensure safe, compliant, and efficient production.
• Lead and support technical investigations related to manufacturing deviations, non-conformances, out-of-specification results, customer complaints, and process excursions. Develop scientifically sound conclusions and recommendations.
• Author and support closure of deviations, CAPAs, change controls, and technical reports in accordance with site quality systems and regulatory requirements.
• Lead or support technology transfer activities from R&D, pilot plant, or external manufacturing sites into commercial production. Conduct laboratory evaluations, engineering studies, scale-up assessments, and process risk analyses.
• Collaborate with cross-functional teams to develop manufacturing strategies and ensure the successful transfer and commercialization of new products.
• Design, optimize, and implement manufacturing processes and equipment for pharmaceutical, OTC, topical, liquid, semi-solid, and aerosol products from pilot scale through commercial production.
• Support process validation activities including protocol development, execution, data analysis, statistical evaluation, and report generation in accordance with FDA, cGMP, and company requirements.
• Author and execute equipment qualification protocols (IQ/OQ/PQ), commissioning activities, and engineering studies to support new and existing manufacturing systems
• Develop User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and technical justifications for new equipment, process improvements, and capital projects.
• Participate in equipment selection, installation, startup, and qualification activities associated with manufacturing and facility upgrades.
• Utilize Lean Manufacturing, Six Sigma, and Operational Excellence methodologies to identify and implement process improvements that improve product quality, increase throughput, reduce waste, and enhance manufacturing efficiency.
• Perform process capability analyses, trend evaluations, and statistical assessments to support data-driven decision-making and continuous improvement initiatives
• Support manufacturing readiness activities for new product introductions and process changes.
• Author, review, and revise SOPs, batch records, validation protocols, technical reports, and engineering documentation required to support cGMP manufacturing operations.
• Maintain expertise in FDA regulations, cGMP requirements, ICH guidelines, and industry best practices related to pharmaceutical manufacturing and validation.
• Support internal audits, regulatory inspections, and customer audits by providing technical expertise, documentation, and responses to observations.
• Participate in quality risk management activities utilizing tools such as FMEA, risk assessments, and…