Equipment Engineer Solids Pilot Plant

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Mechanical Engineering Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Equipment Engineer Solids Pilot Plant to be in Beerse. The role is fixed for three years. About the Department The Drug Product Research & Development (DPRD) is part of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within this organisation the Pharmaceutical Supply & Engineering Sciences team (PSES) is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP). Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year. PSES DP Pilot Plant includes two operational area’s: Solids area: Oral Solid Dosage forms using Batch manufacturing technology like Granulation, Tabletting, Coating and Spray Drying, but also Continuous Manufacturing technology, which will fundamentally change the development and manufacturing of oral solid dosage forms in the near future. Liquid & Parenterals area: Early development in the liquids/parenterals area for both Small Molecules and Large Molecules (monoclonal Antibodies). For our DP Pilot plant in Beerse, Antwerp, Belgium we are looking for an Equipment Engineer Solids. This role will report to the Senior Manager Engineering. Purpose: As part of our equipment and qualification engineering team (both internal and external team members), you will contribute to improving existing installations and delivering new equipment. You will be responsible for: Equipment engineer Develop a thorough understanding of assigned equipments and its interaction with manufacturing processes. Act as as the “go to” person for questions and problems regarding your area of expertise Translate process and user needs into practical technical solutions. Identify improvement opportunities and help implement them. Participate in technical, quality and safety risk assessments. Learn how equipment is designed, installed, commissioned and qualified in a regulated pharmaceutical environment. Build effective relationships with operators, engineers, quality partners, safety specialists and suppliers. Continue developing your expertise through training, contact with equipment suppliers, peer learning and hands-on experience. Share lessons learned and contribute to the technical knowledge of the team. Build technical expertise in solids manufacturing equipment such as feeders, blenders, spray dryers, granulators, tablet presses, continuous manufacturing,… Understand how equipment design affects process performance, product quality, safety and operability. Analyse technical and process requirements and help define suitable solutions. Support troubleshooting and continuous improvement of existing equipment. Participate in Change Control (CHG) and risk assessments such as Hazard and Operability Studies (HAZOP), Structured What-If reviews (SWIFT) and Failure Modes and Effects Analysis (FMEA) Work with internal specialists and suppliers to evaluate new technologies. Gradually become a trusted technical contact for your assigned equipment area. Project engineer Creation and approval of life cycle and qualification documents (User Requirements Specification (URS), Risk assessments, Installation, Operational and Performance Qualification (IOPQ), …), full qualification and deviation handling. Lead and support investment projects from initial concept through start-up and qualification. Support feasibility studies, technology assessments, capacity analyses and business cases. Help define and align project scope, schedule, budget and responsibilities. Coordinate activities across multidisciplinary project teams. Translate user needs into technical requirements and specifications. Participate in supplier selection, design reviews and acceptance testing. Support construction, installation, commissioning and qualification activities in the field, such as Factory Acceptance Test (FAT), Site Acceptance Test (SAT) Take increasing ownership of project delivery as your experience grows. Qualifications / Requirements: A master’s degree in engineering, or equivalent knowledge gained through relevant experience. A sound understanding of general engineering principles and equipment design standards in a GMP environment. The ability to analyse technical information and translate it into practical recommendations. Strong planning, organisation and prioritisation skills. Professional proficiency in English and Dutch. Equipment engineering, manufacturing or technical project delivery. Understanding of (clinical) regulated manufacturing environment such as Pharmaceutical, food, chemical. Good Manufacturing Practice and equipment qualification. Automation and data integrity principles. Machinery safety, explosive atmosphere regulations (ATEX), piping standards or technical risk methods such as Hazard and Operability Study (HAZOP) and Failure Modes and Effects Analysis (FMEA) Project management methods such as Flawless Project Execution (FPX) methodolo