This position requires in-depth knowledge and hands-on experience in Filling and Packaging Process Engineering involving semi-solids (creams, ointments, lotions, gels, etc.), liquids, and suspensions products.
Process Engineer will be able to perform duties related to pilot/scale-up and commercial batch filling and Packaging while collaborating with other internal departments/divisions such as R&D Formulation and Analytical, Packaging Operations, Quality Operations, and Project Management.
- Responsible for drafting/reviewing/approving Packaging Work Orders, Packaging Validation Protocols, OOSs/deviations, change controls, SOPs, etc..
- Oversee filling and packaging activities during Engineering Batches Line Trials and Validations.
- Advise/guide fill/pack personnel as and when needed basis.
- Troubleshoot fill/pack issues, identifying the root cause and owning resolution and corrective actions.
- Represent technical operation division in daily operation meetings and during clients onsite visit.
- Collaborate with internal divisions, clients, and vendors for technical operations related activities.
- Proactively research/review/implement new filling and packaging process engineering techniques/instrumentations.
- Assist with the review and approval of new packaging components.
- Troubleshoot issues that arise and solve problems.
- Degree in Engineering/ Industrial Pharmacy with a minimum of 5 years experience in filling and Packaging of pilot/commercial batches.
- Prefer familiarity with liquids, suspensions, solutions, and semi-solid pharmaceutical dosage forms, cGMPs, and USP.
- Understanding of regulatory requirements related to pharmaceutical product development/manufacturing.
- Excellent scientific writing skills.
- Ability to multi-task various activities.
- Ability to collaborate with R&D Formulation/Analytical, Packaging Operations, Quality Operations to enhance cross-functional transparency and execution success.
- Excellent time management and the ability to work under pressure.
- Ability to discuss scientific strategies/results and interact with the clients internal departments
- Working experience in an FDA regulated environment using GMP/cGMP processes and documentation requirements.
- Advanced level knowledge of Microsoft Word, Excel and PowerPoint.
- Highly motivated individual and willing to learn and grow professionally.