Process Engineer
About The Position
DUTIES: • Lead and execute lifecycle activities from start to end for solid oral dosage, liquid, powder filling, soft gel and semi solid form manufacturing including evaluation, validation, scale up, and lifecycle changes. • Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements. • Assist with on-site transfer projects and product scale-up activities • Review and approve protocols that challenge the critical parameters. • Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met. • Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met. • Assist with initiating change control for new products, site transfer products and changes related to the process improvement with appropriate justification. • Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria. • Author and review investigation reports, protocols, batch records and CMC documentation. • Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects. • Lead and execute material changes, process changes and cost reduction projects. • Provide technical training and assistance to others. • To develop, execute, and oversee cleaning validation protocols for pharmaceutical solid, semi solid, liquid, cream and gel equipment and processes
Requirements
- BS in Pharmacy, Pharmaceutical Science, Chemical Engineering or other related fields and 60 months experience as a as a Process Engineer, Chemical Engineer, Regulatory Compliance Specialist or related
- MS in Pharmacy, Pharmaceutical Science, Chemical Engineering or other related fields and 36 months experience as a as a Process Engineer, Chemical Engineer, Regulatory Compliance Specialist or related
Responsibilities
- Lead and execute lifecycle activities from start to end for solid oral dosage, liquid, powder filling, soft gel and semi solid form manufacturing including evaluation, validation, scale up, and lifecycle changes.
- Analyze statistical data from qualification, product or functional specifications to determine conformance with standards and established quality requirements.
- Assist with on-site transfer projects and product scale-up activities
- Review and approve protocols that challenge the critical parameters.
- Write and execute experimental and validation protocols as per related SOPs and assure that acceptance criterion related to experimental and validation protocols are met.
- Write and execute experimental and validation reports as per related SOPs and assure that acceptance criterion related to experimental and validation reports are met.
- Assist with initiating change control for new products, site transfer products and changes related to the process improvement with appropriate justification.
- Lead investigations, write investigation reports with appropriate scientific understanding, as required upon failures to meet protocol acceptance criteria.
- Author and review investigation reports, protocols, batch records and CMC documentation.
- Lead projects by use of appropriate project management tools, provide timely updates to management on the status of various projects.
- Lead and execute material changes, process changes and cost reduction projects.
- Provide technical training and assistance to others.
- To develop, execute, and oversee cleaning validation protocols for pharmaceutical solid, semi solid, liquid, cream and gel equipment and processes
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
