VALIDATION ENGINEER III

 

PTx is devoted to developing and commercializing cancer medicines and combination therapies that can make a meaningful difference in the lives of cancer patients. We are united in our passion for improving the treatment of cancer and our desire to make a meaningful contribution to outcomes. We believe that innovation is not enough. In today’s challenging healthcare climate, we strive to develop and assess our products based on the real-world impact they have in improving the quality and duration of our patients’ lives. We measure our success in the birthdays, anniversaries, and other important life moments that our patients are able to enjoy.

 

PTx has recently acquired global rights to Leukine (Sargramostim). Leukine is the only licensed FDA-approved GM-CSF, and PTx is investing in Leukine to position it for growth. With Leukine, PTx acquired its state-of-the-art manufacturing facility in Lynnwood and we are North of Seattle, just a few minutes from downtown (but far enough out of, traffic and high cost of living in the city!). We are an established team with a renewed energy to seize on an exciting opportunity. To get there we need outstanding people to join our team of talented, innovative and committed professionals.

 

The Validation Group performs a variety of complex validation tasks in accordance with current GMP’s, and SOP’s.  Develop and/or evaluate equipment process, quality and system standards, to ensure compliance with company standards and regulatory requirements.  Maintains equipment, facilities, utilities, process and computers in a qualified state. No direct reports for this role.

 

POSITION OVERVIEW/KEY RESPONSIBILITIES:

This is an advanced level position requiring multiple years of experience in various areas of Computer System Validation.  This individual plays a lead role in evaluating system validations, equipment, programs, and includes the development of new quality standards and test methods. 

 

  • Aligns site’s validation programs with current industry expectations

  • Develops protocol documentation for new programs, systems and equipment based upon understanding of current industry expectations

  • Assists in the development and maintenance of CSV lifecycle program

  • Leads and/or performs validation and re-qualification field studies on computerized equipment and systems

  • Participates as technical lead in failure investigations associated with studies being executed (Conducts critical and non-critical failure investigations)

  • Tracks/schedules validation projects and authors final reports for executed validation studies

  • Provides training for Validation Department, site and contract validation personnel.

  • Supports Change Control as a validation technical lead and ensures timely completion of required tasks

  • Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs.

 

BASIC QUALIFICATIONS:

Relevant experience may supersede degree requirements.

  • Bachelor’s degree and 9 or more years of relevant experience or Master’s and 7 or more years of relevant experience in Computerized Systems Validation, cGMPs, is required

  • An in-depth understanding of Data Integrity principles and current industry best practices is required.

PREFERRED QUALIFICATIONS:

  • Some non-CSV validation/qualification experience (i.e., cleaning/equipment/process)

  • Experience with Microsoft Access or other related relational database

  • Experience with Microsoft Office products, including Word and Excel

 

LEADING THE BUSINESS:

  • Operate in an evolving, complex and dynamic environment, providing clear direction and instruction to supervisors and direct reports, and continuously looking internally and externally for best practices and areas for improvement.

 

Compensation and benefits are very competitive. They include a base salary, performance bonus, stock options and profit sharing. Our benefits include health, vision, dental and life INS, 401(k) with match & PTO

 

To be considered for the position, please send your resume to Brooklyn.borges@partnertherapeutics.com

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Lexington, MA 02421

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