Valeant Pharmaceuticals

Manager, Engineering Process

US-FL-Tampa
Job ID
7166
Pos. Category
R&D
Pos. Type
Full Time

Overview

 Valeant Pharmaceuticals International, Inc. is a diverse and decentralized pharmaceutical company that is committed to focusing on our key stakeholders while delivering consistently high performance.  Our values provide the overall direction for our company, and provide us with the tools necessary to rise to any challenge by leveraging our collective hard work and effort along with our unwavering competitive spirit.  These values help us set goals based on our organization’s potential and what we hope it will become.

 

To provide leadership to a team of engineers responsible for designing and executing the development and validation of new manufacturing processes, investigating manufacturing issues and improving existing processes.

Responsibilities

Provide functional and hands-on technical leadership for a team of 3-8 Process Engineers with tactical responsibility for:

  • Process development and characterization for manufacture of sterile and non-sterile solutions, suspensions, emulsions, ointments and gels
  • Process validation
  • Annual product reviews
  • Investigations supporting R&D and commercial manufacturing
  • Maintenance of business changes to processes
  • Documentation including protocols, technical reports, summary reports for regulatory submission, and SOPs

Provide strategic leadership for the engineering function in alignment with R&D business goals for product development and, as assigned, site-based maintenance of business activities. 

Negotiate cross-functional resources to accomplish goals.

Provide for development of individual subject matter experts in key technologies. 

Provide technical leadership to development teams and manufacturing operations.

Evaluate internal systems and processes and provide direction and leadership to enhance their efficiency and effectiveness towards achieving business goals.

Estimate resources, budgets and completion dates for technical projects.

Review CMC sections of Regulatory filings for accuracy and completeness of information.

Perform technical assessments of new products as part of due diligence.

Qualifications

  • BS, MS or PhD in Engineering or related physical science
  • Effective skills in data analysis and technical writing
  • Supervisory and mentoring skills
  • Experience working in a team environment
  • Familiarity with GMPs and Quality by Design principles

Experience with sterile products, cleaning validation, process validation, equipment qualification are a plus

 

 

A minimum of 5 years of experience in process engineering, technical services and/or validation roles in pharmaceuticals or other FDA regulated industry

Be Aware of Recruiting Fraud

Job Applicants should be aware of job offer scams perpetrated through the use of the Internet and social media platforms.

 

To learn more please read Valeant’s Job Offer Fraud Statement.

 

 

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