Our client, a well-established, pharmaceutical organization is seeking a highly experienced and technically accomplished Principal Engineer to serve as the technical leader for Oral Solid Dosage (OSD) platform within our Manufacturing Science & Technology (MSAT) organization.This role will lead the site's OSD commercial manufacturing technical support activities, technology transfers, and continuous improvement initiatives. The Principal Engineer will be responsible for solving complex technical challenges, strengthening process understanding, and ensuring robust, compliant, and efficient manufacturing processes.This position is designed for a deep technical expert who thrives in solving complex problems, influencing cross-functional teams, and driving meaningful improvements in cost, yield, and product quality.ResponsibilitiesTechnical Leadership & Platform DevelopmentServe as the site-wide technical authority for OSD manufacturing processesDefine and evolve the OSD technical platform, including process standards and best practicesEstablish strong process knowledge and improve control strategies across products and unit operationsAct as the site's technical representative for new product entry on cross-functional development programsManufacturing Support & TroubleshootingLead complex investigations related to process deviations, atypical events, and product quality issuesProvide hands‑on technical support to manufacturing operationsPerform structured root cause analysis and implement sustainable corrective actionsTechnology Transfer & Scale‑UpSupport technical activities for new product introductions (NPI) and technology transfers from R&D into the siteEnsure effective translation of process knowledge from development to commercial manufacturingLead both intra and inter‑site tech transfer of established commercial processesSupport process validation and lifecycle management strategiesContinuous ImprovementDrive initiatives to improve yield, throughput, and cost of goods (COGs)Apply data‑driven and scientific approaches to enhance process robustnessIdentify and implement process and equipment optimization opportunitiesCross‑Functional CollaborationPartner with Manufacturing, Quality, Engineering, PharmDev, Technical Operations and Validation to ensure successful execution of technical initiativesServe as a trusted technical advisor across the organizationRegulatory & Compliance SupportEnsure all activities meet GMP and regulatory expectationsSupport regulatory submissions, inspections, and audits as a subject matter expertAuthor and review technical documentation, investigations, and reportsQualificationsEducation and ExperienceMaster's degree in Engineering, Pharmaceutical Sciences, or related field (required)Ph.D. (preferred)ExperienceMinimum 15 years of experience in pharmaceutical manufacturing or developmentSignificant experience in oral solid dosage processes and technologiesProven track record in:Complex problem‑solving and troubleshootingTechnology transfer and scale‑upProcess optimization and continuous improvementTechnical SkillsStrong expertise in OSD unit operations (e.g., blending, granulation, compression, coating; both cosmetic and functional)Experience with data analysis, statistics, and process modelingDeep understanding of GMP and regulatory requirementsLeadership AttributesDemonstrated ability to lead without authority and influence cross‑functional teamsStrong communication skills, with the ability to translate complex concepts into practical solutionsAbility to operate effectively in a fast‑paced, technically complex environment#J-18808-Ljbffr
Germer International is a recruiting firm that specializes in placing professionals and executives in the Pharmaceutical, Biotech and Medical devices industries. We are a company that builds strong companies, one placement at a time. The firm was founded in 2002 by John Germer, who began his recruiting career in 1987. John Germer and his staff are focused on significantly growing the company by building on John’s years of experience as well as through the team’s relentless pursuit of finding the best candidates for their clients. Germer International has grown and continues to grow because of our unique knowledge of the Pharmaceutical Industry and because of the depth of our contacts. However, the most critical factor in our growth thus far, and the reason we will continue to further dominate is because of our hiring practices and because of our training. GI understands that the better our people are, the better our services will be. So, by hiring the right people and providing them with the right training, our services will grow in demand. Germer International's recruiting expertise is in the areas of: Pharmaceuticals Chemistry (Analytical, Formulation, Process Development, Synthesis, Medicinal) QC/QA Sales & Marketing Purchasing/Supply Chain Regulatory Clinical Preclinical Engineering Production Executives IT Human Resources For recruiting professionals in the Pharmaceutical and Biotech industries it is Germer International...It's that simple.