Principal Process Engineer

Principal Process Engineer – OSD (Oral Solid Dosage)Brooksource Engineering ServicesOverviewBrooksource Engineering Services is seeking a Principal Process Engineer to support the design, delivery, and optimization of advanced pharmaceutical manufacturing facilities, with a focus on Oral Solid Dosage (OSD) operations.This role will serve as a technical leader on capital projects, ensuring process design, equipment selection, and system performance meet business, regulatory, and operational requirements. The ideal candidate brings deep technical expertise, strong stakeholder engagement, and experience delivering GMP-compliant manufacturing solutions.Key ResponsibilitiesProvide technical leadership and direction across process engineering activities for capital projectsTranslate business and operational requirements into robust, scalable technical solutionsLead technology selection, capacity modeling, and preliminary equipment sizingDevelop and review User Requirement Specifications (URS) to ensure accuracy and readiness for validationConduct and lead process risk assessments to ensure safety, quality, and complianceSupport supplier selection, procurement activities, and bid evaluationsCollaborate with equipment vendors, engineering firms, and construction teams to deliver integrated manufacturing systemsReview and approve process design documents and vendor technical submittalsPerform construction-phase technical audits and oversee Factory Acceptance Testing (FAT)Support commissioning, qualification, and validation (CQV) activities for GMP equipmentProvide ongoing technical support to manufacturing sites and external partners to optimize process performanceRequired QualificationsStrong technical expertise in Oral Solid Dosage (OSD) unit operations (e.g., blending, granulation, compression, coating, packaging)Experience with GMP equipment lifecycle: specification, procurement, installation, commissioning, and qualificationProven ability to lead technical decision-making on complex capital projectsStrong communication and stakeholder management skills across cross-functional teamsExperience working with equipment suppliers, EPC firms, and manufacturing operationsPreferred QualificationsExperience in large-scale pharmaceutical capital projectsFamiliarity with process modeling and capacity analysis toolsKnowledge of regulatory requirements (FDA, EMA, cGMP)Experience supporting multi-site or global manufacturing operationsAbout Brooksource Engineering ServicesBrooksource Engineering Services delivers high-impact engineering talent and project solutions across regulated industries, including pharmaceutical and advanced manufacturing. Our teams specialize in capital project execution, process optimization, and technical consulting, helping clients bring innovative manufacturing capabilities online efficiently and compliantly.