Process Validation Engineer - Drug Finish and Packaging
Proclinical is currently recruiting for an Engineer of Drug Finish and Packaging with a pharmaceutical company located in Bloomington, IN. Successful candidate will be held responsible for ensuring fit for plant and commercial readiness during technical development and execution of the transfer of pharmaceutical processes from and products from Development into the supply chain and the global marketplace, as well as transfer of processes between sites.
- Packaging Technical and Manufacturing integration of new and/or re-developed drug products from R&D (PDMS or VPAD) into the supply chain.
- Contribution, review and approval of packaging technical and regulatory documents, routine technical support during execution, integration of technical expertise into project execution and QbD technical implementation at the manufacturing site level.
- Single point of contact for plant readiness and execution from technical transfer into commercial production including launch support.
- Leading the packaging site team and taking the role of packaging site representative on the CMC Subteam and the New Product Team (NPT).
- Identifying and implementing opportunities for active decrease COGs and partnering with Development and groups to develop and implement strategies to improve the fit for plant and commercialization of new products into the supply chain.
- Partnering with the Technical Integrator (TI) to provide all DP manufacturing site related needs to the DPD Subteam as the single point of contact at the site.
- Developing the packaging/manufacturing site execution plan per product, in line with the overall strategy and plan as outlined by the CMC DPD Subteam and NPT. The Technical Professional will ensure alignment and endorsement of this strategy within the manufacturing site and Technical function.
- Providing required packaging technical support, document technical input, review and approval and serving as the technical expert.
- Coordinating and executing product introduction at the site from transfer through launch covering raw materials, formula, process, packaging and device integration into the finished product and supporting the New Product Lead (NPL) for site related launch activities.
Skill and Requirements:
- BS/BA with 8 years' experience minimum, MS with 7 years' experience or PhD with up to 3 years' experience in packaging or pharmaceutical development or pharmaceutical manufacturing or related post graduate academic experience/education.
- Knowledge of both pharmaceutical product R&D and Packaging/Manufacturing / Technical Operations functions.
- Planning and logistics skills capable of effective integration of Packaging
- deliverables to support detailed execution at the manufacturing site level.
- Experience with introduction of pharmaceutical products to manufacturing sites and late state development with technical knowledge of manufacturing site unit operations and packaging operations.
- Knowledge of manufacturing site systems and procedures, and packaging equipment.
- Personal and interpersonal skills / Leadership skills.
- Demonstrated leadership in providing integration of activities and information across multifunctional groups and matrix teams.
- Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.
- Ability to influence peers, superiors, and partners.
- Motivated, self-starter able to work independently with demonstrated problem solving skills.
- Fluent in written and spoken English.
If you are currently available and interested in hearing about this opportunity, please do not hesitate to reach out!
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Max Kelly at (+1) 312-270-1613, M.Kelly@Proclinical.com, or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.