Validation Engineer (Mulitple Office Locations)
Laporte Consultants is an engineering firm specialized in process, building, and utility design. Laporte provides a complete range of professional services to pharmaceutical, biotechnological, and industrial food and beverage clients. Laporte operates in the United States, Canada, and Europe. For more information, please visit our website: www.laporteconsultants.com.
This position is responsible for supporting the validation of various equipment/systems and processes for new and existing pharmaceutical, biopharmaceutical, and medical device clients according to industry standards and applicable client’s global/site standards.
Depending on the assignment, the role may require 25% travel to client sites outside PA .
Responsibilities and Duties:
Located on either the client site in the Philadelphia area or out of our King of Prussia office and reporting to the Operations Director, East Coast, the engineer will be responsible to support and lead the validation requirements for various client projects:
- Responsible for supporting validation projects for our clients including: authoring and executing Validation Lifecycle documents such as 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), and Process Validation (PV) protocols/report in accordance with corporate and departmental procedures.
- Perform Validation Periodic Review for various systems including process equipment, computerized systems, and laboratory equipment. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across sites to determine status, gaps, and corrective actions.
- Draft, revise, and provide technical input with respect to Standard Operating Procedures development.
- Perform equipment risk assessments to assess impact of system functionality and control on product quality.
- 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, client, and vendors to complete required activities.
- 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 with the agreed scope and timelines.
- BS or MS in Engineering field is required, or equivalent experience.
- Minimum 2 years of hands-on experience preparing and executing validation lifecycle documents (at least IQ/OQ/PQ) for related facilities, utilities, and process equipment in Life Science (medical device, biopharmaceutical, pharmaceutical, etc.).
- Familiarity with current industry standards cGMP, GLP, GAMP5, and CFR21 Part 11.
- 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 demonstrate a sense of urgency, flexibility, and accountability.
- Ability to prioritize and manage multiple projects at the same time.
- Proficiency in using the Microsoft Office Suite.
- Flexibility to travel to the client site on a frequent basis.
- Prior experience in analytical equipment and computerized system validation.
- Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA), Failure Mode Risk Assessment (FMRA), or critical parameter risk assessments.
- Strong leadership, relationship management, and organizational planning and project management skills, in addition to technical knowledge.
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.