• United States Of America, Usa
  • Save Job
  • 5 - 7 Years
  • Posted : above 1 month

Job Description:

Responsible for the Production Process Development, Scale Up, and Commercialization of parenteral pharmaceutical products at the Piramal Manufacturing Facilities As a discipline of engineering, this position includes all product and process activities related to the manufacture of new products Responsible for design, project management, implementation, enhancement and validation of new and existing systems, processes, and equipment to support the transfer of new products from R&D to Clinical and Commercial Manufacturing

ESSENTIAL FUNCTIONS

Manage a team of Process Engineers to Tech Transfer new products and develop the product for Commercial Manufacturing including the development and challenging of critical quality parameters and attributes (CPPs and CQAs) including QTPP, scale up report, and final product specific technical documentation following QbD Q8, Q9, and Q10

Identify and assign Continuous Improvement Projects

Represents Technical Subject Matter Expert (SME) in Product Development, Scale Up, and Optimization of new products

Supports day-to-day production and maintenance activities as required for product specific attributes, characteristics, and behavior

Provides training support as required

Participates in deviation investigations to identify root causes and define corrective and preventive actions (CA/PA) as related to product chemistry and manufacturing properties

REQUIRED COMPETENCIES KNOWLEDGE, SKILLS, ABILITIES

Primary/First Line responsibility for product transfer from R&D into a robust manufacturing process on commercial equipment

Primary/First Line responsibility for developing the scale up plans for all products given commercial gating

The individual must have the ability to lead and manage in approving departmental activities, following through to completion The individual must work with other functional groups priorities in order to drive departmental projects to completion within the committed schedule

The individual must be able to work within and lead in a team environment, consisting of multi-functional groups, to achieve a common goal, while promoting teamwork, timeliness, accuracy and compliance in all activities

The individual must be able to interact with management and peers within the department, within the plant, within the organization and outside regulatory agencies The individual must also interact with vendors and consultants on a routine basis

Must direct the activities of other technical or non-technical personnel May occasionally be required to supervise operators/mechanics, technicians, peers or outside consultants/contractors

Responsible for the reliability of the production process - Reliability of Validated Systems, Critical Utilities, and Production related systems is critical to the ability of the Lexington Facilities to successfully manufacture pharmaceutical products

This individual may become familiar with proprietary and confidential information in the performance of routine duties Disclosure of such proprietary and confidential information may have a serious detrimental effect to Piramals and/or our clients business, and may result in disciplinary or legal consequences

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS

This position requires concentrated effort in recording, evaluating and transcribing data, as well as computer work, which can cause mental and/or eye fatigue The work is performed in a clean environment

Qualifications

EDUCATION/EXPERIENCE REQUIREMENTS

Minimum 4-year degree in Mechanical, Biological, or Chemical Engineering; or equivalent years of field experience

5-7 years of related experience; Pharmaceutical manufacturing/development experience required

Expertise in product scale up

PC literate with standard office application (Word, Excel, PowerPoint) competency

Knowledge and understanding of cGMPs; Knowledge of cGMP validation requirements and techniques

Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques

Experience managing direct reports

Knowledge and experience in project management, including development of processes and products

Well versed in Quality by Design and Scale Up of pharmaceutical products

Knowledge and understanding of the regulatory approval process for US and EU

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 16th Mar 2020

Key Skills:

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