Senior Process Engineer

OverviewBe part of a dynamic team that designs and develops manufacturing processes for new delivery systems from concept through design transfer and product launch. This process development team is committed and driven in our mission to revolutionize the way we manufacture delivery systems while producing a high-quality product for our patients and customers.The ideal candidate will be a seasoned professional with a passion for advanced manufacturing and the development of manufacturing processes during product development phases. The candidate will be involved with process development, setting up manufacturing operations, and interfacing cross-functionally with other key engineering expertise to develop a this role, you will be part of a team but will be able to work independently with limited supervision to determine and develop approaches to solutions. You will coach and review the work of lower-level professionals. You may manage projects/processes. You will communicate with senior internal and external customers and suppliers. Your work will involve collaboration and dynamic interactions with R&D and Design Assurance regarding products in the development pipeline and with operation team members for new or iterative product implementation. Problems and issues faced are difficult and may require understanding of multiple issues, job areas or specialties. ResponsibilitiesResponsibilities may include the following and other duties may be assigned:Process Technologies: Lead the exploration and development of new process technologies that may be incorporated into new product development projects or existing manufacturing lines. Analysis provided is in-depth in nature and often provides recommendations on process improvements.Process Development: Lead new product development by designing and developing manufacturing processes for new products that facilitate ease of manufacturing while producing quality, cost effective products with optimized yields. Such activities include, but are not limited to,:Manufacturing Studies: Work with engineering team on studies to characterize process inputs to drive development of critical manufacturing/process specifications that are both robust and meet quality expectations. Use appropriate statistical support and Design of Experiments (DOE).Equipment and Fixture Development: Identify equipment and fixture needs within pilot line and/or manufacturing operations.Documentation: Generate required documentation in support of manufacturing products and processes. These include engineering protocols/reports, PFMECAs and manufacturing instructions. Ensure compliance with internal procedures, GMP and regulations.Qualification and Validation: Generate and execute plans for equipment qualification and process validation. Lead test method development and validation where needed. Must Have: Minimum RequirementsBachelors Degree in a related engineering discipline (i.e., mechanical, biomedical, industrial, materials science) with 4-7 years of experience or Advanced Degree with 4+ years of experience Nice to HaveDemonstrated problem-solving and critical thinking experienceSolid oral and written communication skills, including presentation skillsSolid interpersonal skills and ability to work in a cross-functional team environmentSolid understanding of statistical techniques and analysisDesign for Reliability and Manufacturability (DRM) experienceDemonstrated computer skills such as Minitab, Excel, Word and ProjectProcess Validation (IQ/OQ/PQ) and Test Method Validation experience Seniority levelMid-Senior level Employment typeContract Job functionMedical Equipment Manufacturing Referrals increase your chances of interviewing at Planet Pharma by 2xGet notified about new Process Engineer jobs in Danvers, MA. #J-18808-Ljbffr

Created: 2025-09-18