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Patheon
Process Engineer and OE Lead
Princeton, NJ - USA
Posted January 11, 2017

Join us as We Transform How Pharmaceuticals are Made.

Patheon is looking for people who are passionate about making a difference in people’s lives. Patheon is in need of proven leaders to nurture talent, build effective teams and drive engagement in an environment where people are motivated to do their best for the company, its clients and their patients. To inspire collaboration and innovation.
Summary

Summary:

The Process Engineering and Operational Excellence Lead will drive transformational improvement projects throughout the site by utilizing Operational Excellence methodology and fundamental engineering practices. This individual will have exellent leadership and project management skills, which will be coupled with a passion to build a culture of continuous improvement across the site.

 

He/She will determine and build an execution plan to meet the site’s annual value capture targets. Additionally, they will manage budgets for assigned capital projects. This individual will also be the corporate contact for Operational Excellence initiatives and be expected to report and present on the site’s progress.

 

Project scopes may include, but not limited to, support of existing operations, design and commission new facilities, commissioning and qualification of equipment, and general process improvements. To complete these projects, this candidate must be comfortable utilizing various resources including internal cross-functional teams, external engineering partners, suppliers, construction personnel, and OE tools.

Essential Functions:

  • Lead the site Operational Excellence team to implement a continuous improvement culture across the site
  • Prepare and present reports/presentations for various site and corporate stakeholders
  • Lead individual Six Sigma/Lean projects that have an impact on business metrics
  • Coach and develop others by using motivational and mentoring techniques
  • Provide engineering support for critical utility equipment and biologics processing equipment to support upstream and downstream process development, pilot plant, and analytical laboratories.
  • Works in conjunction with Development, QA and Validation to troubleshoot existing operations and provide input on process or facilities improvements.
  • Provides real time floor support to critical utility operation and labs in responding to critical alarms and failures as needed (including on-site response potentially after hours)
  • Manages capital project design and execution.
  • Provides engineering support for investigations, and corrective actions.
  • Maintains and/or creates necessary engineering documentation (drawings, data, software, etc.) for responsible equipment.
  • Review reports and/or data from external contractors/vendors, approves (as necessary) to ensure completeness and accuracy
  • Assist department director with projects and initiatives as assigned.
  • Participate in audits by insurers, regulatory agencies, and government officials and ensures compliance with regulations.
  • Administer assigned areas of department budget.
  • Maintain reliable attendance.

 

ADDITIONAL RESPONSIBILITIES:

 

  • Performs other duties as assigne
Key Requirements

Essential Functions:

  • Lead the site Operational Excellence team to implement a continuous improvement culture across the site
  • Prepare and present reports/presentations for various site and corporate stakeholders
  • Lead individual Six Sigma/Lean projects that have an impact on business metrics
  • Coach and develop others by using motivational and mentoring techniques
  • Provide engineering support for critical utility equipment and biologics processing equipment to support upstream and downstream process development, pilot plant, and analytical laboratories.
  • Works in conjunction with Development, QA and Validation to troubleshoot existing operations and provide input on process or facilities improvements.
  • Provides real time floor support to critical utility operation and labs in responding to critical alarms and failures as needed (including on-site response potentially after hours)
  • Manages capital project design and execution.
  • Provides engineering support for investigations, and corrective actions.
  • Maintains and/or creates necessary engineering documentation (drawings, data, software, etc.) for responsible equipment.
  • Review reports and/or data from external contractors/vendors, approves (as necessary) to ensure completeness and accuracy
  • Assist department director with projects and initiatives as assigned.
  • Participate in audits by insurers, regulatory agencies, and government officials and ensures compliance with regulations.
  • Administer assigned areas of department budget.
  • Maintain reliable attendance.

 

ADDITIONAL RESPONSIBILITIES:

 

  • Performs other duties as assigne
Qualifications

Job Scope:

Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Frequently interacts with supervisors, group managers, site leadership, and corporate stakeholders. May interact with senior management. Interactions normally involve matters between functional areas.

 

 

Supervision:

  1. A portion of the time will be spent performing individual tasks.
  2. Supervises outside engineering contractors, construction contractors, or service providers as assigned.

 

 

Education:

    • Bachelor of Science Degree in Engineering or equivalent experience
    • Masters/PhD is a plus
    • CERTIFICATES, LICENSES, AND/OR REGISTRATIONS

 

 

Experience:

    • Requires a Bachelor of Science Degree in Engineering with 2-5 years or Master of Engineering with 1-3 years in a pharmaceutical/biotechnology role.
    • Direct experience working in a process/project engineering role in a biopharmaceutical manufacturing facility
    • Prior experience with biologics, proteins/vaccines unit operations (automated bioreactors and chromatography systems), high purity water systems and/or plant utilities.
    • Excellent organizational skills.
    • Experience with design, construction and commissioning of biologics processing equipment a plus
    • Excellent Communication Skills
    • Excellent computer skills (Excel, Word, PowerPoint, and Outlook)
    • AutoCAD skills a plus
    • Familiar with statistical analysis tools (MiniTab, JMP, etc.)

 

 

 

Equivalency:

Equivalent combinations of education, training, and relevant work experience may be considered.

 

 

Competencies: Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Frequently interacts with supervisors, customers, and group managers. May interact with senior management. Interactions normally involve matters between functional areas.

 

 

Physical Requirements:

Example - Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.

 

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

 

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.

Help Us Make a Healthier World.

Patheon provides development and manufacturing services for more than 800 pharmaceuticals, including nearly a fifth of the world’s top selling drugs. We’ve helped our clients earn more than twice as many U.S. FDA approvals than any other CDMO. Are you as committed as we are to exceeding expectations with high-quality solutions to complex problems? If so, we want to talk to you about making a healthier world... together. Join us at patheon.com
Disclaimer

Patheon is an Equal Opportunity/Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

 

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