Process/ Equipment Engineer

Hercon Pharmaceuticals is dedicated to the manufacturing and development of generic transdermal medications. Managed by Cadila Healthcare, a fully integrated global healthcare provider with over 20,0000 employees, we have an opportunity available in our Pharmaceutical Transdermal Manufacturing Facility located in York, PA.

The Process/ Equipment Engineer takes the lead role in product scale-up activities from lab to commercial manufacture. Responsible for developing, executing, and reporting drug process qualification protocols and cleaning validation protocols for pharmaceutical product. Responsible for developing batch records and leading execution of exhibit batches. Develops and maintains accuracy of master production batch records. Ensures that component, process, and equipment changes are assessed and re-validated when appropriate. Reviews and analyzes process and stability data and writes technical reports in support of regulatory filings.

Educational Qualifications:

• S. in Mechanical Engineering or Industrial Engineering.

Required Experience:

• 3-5 years of experience with design engineering in a manufacturing operation.
• Experience in equipment processes for pharmaceutical process and manufacturing equipment.
• Some experience with Scale-up of pharmaceutical dosage forms.

Essential Functions/Responsibilities:

• Knowledge of manufacturing equipment for pharmaceutical dosage forms.
• Scaling up the processes for lab scale to pilot scale to commercial scale with liquids, tablets, ointment creams.
• Must have experience in writing product development and scale-up protocols and reports.
• Hands-on experience in transdermal product development
• Knowledge of process/cleaning validation
• Understanding of FDA, SUPAC, CAPA, cGMP, DEA, and ICH guidelines

Desirable to have transdermal, topical, adhesive, liquid or ointment creams scale-up experience.

We offer a competitive salary and benefits package.  Send resume to HR@herconpharma.com

Current Openings for Process/ Equipment Engineer Jobs at Zydus Pharmaceuticals