Validation Engineer

Date:

Summary/objective:

This position is responsible for supporting the validation of various systems across manufacturing areas and assure the validation programs are compliant with clients global/site standards and industry practices.

Responsibilities and Duties:

Located in King of Prussia, PA, and reporting to the Operations Director, East Coast, the engineer will be responsible to support and lead the validation requirements for client projects:

  • Carry out all aspects of a validation project for our Biopharmaceutical clients including: authoring/reviewing/executing Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specifications (URS), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ),and Performance Qualification (PQ) protocols/report, risk assessments, and periodic reviews in accordance with corporate and departmental procedures;
  • Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to ensure correct interpretation of the information;
  • Coordinate validation activities between the Laporte team and client
  • Participate on cross-functional teams to address specific problems, facilitate discussion, research and assist with deviations investigation, change controls write-up
  • Provide technical input with respect to Standard Operating Procedures development; review or revise SOP’s as required to assure that all needs are addressed, and compliance and industry standards are incorporated;
  • Develop the site requalification plan and strategy, execution and implementation; must be able to evaluate current processes and procedures and lead a validation team;
  • Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities;
  • Ensure that projects are implemented in accordance within the agreed scope and time lines.

Qualifications

  • B.S. degree in a relevant engineering field;
  • Minimum of 2 years of progressive experience in a GMP/ pharmaceutical environment, writing and executing validation documents, IOQ/PQ protocols;
  • Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process;
  • Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required;
  • Experience validating QC equipment and 21CFR Part 11 preferred;
  • Experience with MES batch records preferred;
  • Familiarity with Good Manufacturing Practices, as well as Lean Manufacturing/Six Sigma;
  • Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge;
  • Strong ability to work in a team environment;
  • Ability to exercise independent judgment in methods, techniques and evaluation criteria for obtaining results;
  • Knowledge of post-implementation continuous improvement efforts and methodology;
  • Ability to influence clients, suppliers and peers into adopting « best practices » in the engineering field;
  • Excellent communication skills – verbal, written, listening and interpersonal with the ability to transfer knowledge to others;
  • Capability to engage and energize others to reach their fullest potential and performance;
  • Ability to demonstrate a sense of urgency, flexibility and accountability;
  • Versatility in disciplines other than the one academically trained for is highly desired;
  • Proficiency in using the Microsoft Office Suite;
  • Flexibility to travel to the client site on a frequent basis.

 

Come join a company that is currently expanding across multiple geographic areas in North America – both Canada and the US. Laporte offers a competitive salary and benefits and an environment that promotes work-life balance and professional growth.

  • Please attach files including your resume *

  • Déposer les fichiers ici ou
    Types de fichiers acceptés : doc, pdf, jpg, Taille max. des fichiers : 10 MB.
      (Word, PDF and JPEG files accepted – Maximum 10 MB)