This position is responsible for supporting the validation and quality engineering of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing areas and assure the equipment/system and validation programs are compliant with the client’s 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 and executing Validation Master Plan (VMP), Validation Plan (VP), User Requirements Specifications (URS), Risk Assessments, Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV) protocols/report in accordance with corporate and departmental procedures;
- Perform equipment risk assessments to assess the impact of system functionality and control on product quality and troubleshoot equipment/system when errors occur in order to provide recommended actions to clients.
- Perform Validation Periodic Review for various systems including computerized systems, laboratory equipment. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across the site to determine status, gaps, and corrective actions.
- Represent Validation and participate on cross-functional teams to assist with deviations investigation, CAPA, and change controls write-up;
- Coordinate validation activities between the Laporte team and client to complete required activities;
- Provide technical input with respect to Standard Operating Procedures development; revise or develop SOP’s as required to assure that all needs are addressed, and compliance and industry standards are incorporated;
- 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 timelines.
- B.S. degree in a relevant engineering field;
- Minimum of 2 years of direct work experience in a GMP/ pharmaceutical environment, writing and executing commissioning and validation;
- Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required;
- Familiarity with Good Manufacturing Practices;
- Strong ability to work in a team environment and capability to engage and energize others to reach their fullest potential and performance;
- Excellent communication skills – verbal, written, listening, and interpersonal with the ability to transfer knowledge to others; Ability to influence clients, suppliers, and peers into adopting “best practices” in the engineering field;
- Ability to demonstrate a sense of urgency, flexibility, and accountability;
- Proficiency in using the Microsoft Office Suite;
- Flexibility to travel to the client site on a frequent basis.
- Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA), Failure Mode Risk Assessment (FMRA), or critical parameter risk assessments;
- Familiarity with current industry standards cGMP, GLP, GAMP5, and CFR21 Part 11;
- Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge;
- Ability to exercise independent judgment in methods, techniques, and evaluation criteria for obtaining results;
- Prior experience interfacing with regulatory agencies, as well as exposure to the regulatory submission process;
- Knowledge of post-implementation continuous improvement efforts and methodology.