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.
- 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.