Equipment Expert - Process and Installation
We have an exciting opportunity for you to join our dynamic team at Recipharm. As an Equipment Expert - Process and Installation , you will play a crucial role in supporting the development and transfer of manufacturing processes by providing expert knowledge in equipment selection, installation, and qualification. What you'll be doing: Leading and executing feasibility studies to evaluate the suitability of equipment for new and existing manufacturing processes. Providing expert technical guidance on the selection, specification, and procurement of new manufacturing equipment, ensuring alignment with process requirements and business needs. Developing and executing comprehensive qualification and validation protocols (IQ, OQ, PQ) for a wide range of manufacturing equipment. Contributing to the implementation of Quality by Design (QbD) principles by ensuring equipment capabilities are well-understood and aligned with process requirements. Driving continuous improvement initiatives to optimize equipment performance, process efficiency, and overall productivity. Collaborating with teams on process development to ensure equipment capabilities meet the demands of new product introductions and technology transfers. Collaborating closely with Global and Local Procurement, Manufacturing, Quality and Engineering teams to define concepts for strategic expansion, and to ensure successful process transfers and scale-up. Staying abreast of the latest industry trends, technologies, and regulatory requirements related to pharmaceutical manufacturing equipment. Contributing to risk assessments and ensuring equipment and processes adhere to GMP and safety standards. Managing vendor relationships, including supporting new vendor negotiations, and ensuring effective communication and collaboration. What you'll bring to the team: A Bachelor's or Master's degree in Engineering or a related technical discipline. Significant and demonstrable experience (typically 8+ years) in equipment process and installation within the pharmaceutical or biopharmaceutical manufacturing industry, preferably within a CDMO environment. In-depth knowledge of GMP regulations and quality standards related to pharmaceutical manufacturing equipment. Proven experience in managing equipment installation, commissioning, and qualification projects. Strong technical understanding of a wide range of pharmaceutical manufacturing equipment and processes. Excellent problem-solving, analytical, and troubleshooting skills. Demonstrated ability to work effectively in cross-functional teams and communicate clearly and concisely. Experience with change control processes and documentation management. A proactive and results-oriented approach with a strong focus on quality and efficiency. Location This is a Hybrid role which will be based near our site in Bengaluru. There is a requirement for travel across Recipharm sites. Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,200 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production. Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden. For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com URL to this page https://www.recipharm.com/careers/job-search/apply?rmpage=job&rmjob=3541&rmlang=UK Show more Show less