Proclinical is currently recruiting for a Drug packaging Validation Engineer with a pharmaceutical company located in Bloomington, IN. Successful candidate will be responsible for packaging technical support and oversight for the supply chain, planning and execution of packaging site level support of new product launch.
Job Responsibilities:
- 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 JSC technical expertise into project execution and QbD technical implementation at the manufacturing site level.
- Single point of contact for JSC 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 JSC 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 JSC 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 JSC 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.
Skills and Requirements:
- BS degree and experience within these functions of Large Molecule Parenteral pharmaceuticals: research and development, Technical Operations, API/ Drug Product Manufacturing, Quality, Regulatory, Drug Development.
- Knowledge in process validation, equipment qualification and aseptic process equipment requirements.
- Strong technical and analytical skill to lead multi-functional and third-party teams for complex investigations, Tech Transfer, process validation.
- The job requirements are specific and fast paced - candidates should have a technical & manufacturing background with a detailed aseptic processing understanding, regulatory requirements understanding and good analytical mindset.
- Ability to write technical documents, tabulate and review analytical data and drive sounded scientific conclusion.
- Good project management skills and ability to keep record, action items track system.
- Proven ability to partner and work with multiple departments and manage projects, technical transfer, cross-functionally, cross-geography, and with cross-company teams highly preferred.
- Experience in large molecule and aseptic process highly preferred.
- Ability to support the execution supervising on the floor activities, ability to issue gnat chart, work with excel, word, minitab statistical analysis.
If you are currently available and interested in hearing about this opportunity, please do not hesitate to reach out!
To Apply:
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.
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