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 client’s global/site standards and industry practices.

Responsibilities and Duties:

Located in Raleigh, NC, the validation specialist/engineer will be responsible to support and lead the validation requirements for client projects. Responsibilities are as follows:

• Carry out all aspects of a validation project for our Biopharmaceutical clients including: authoring and/or executing Validation Master Plan (VMP), User Requirements Specifications (URS), Risk Assessments (RA), Design Qualification (DQ), Factory Acceptance Test (FAT), Site Acceptance Test (SAT), Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Process Validation (PV) protocols/reports in accordance with corporate and departmental procedures.
• Act as the Validation Lead for the Projects.
• Validation Planning: Develop validation master plans outlining the validation strategy, scope, and timelines for the project.
• Coordinate Validation activities between the Laporte team, client, and vendors to complete required activities.
• Documentation Management: Oversee and manage the document flow such as creation, review, and approval of validation protocols, reports, and other documentation required for validation activities.
• Execution and management: Oversee and manage the execution of validation protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for equipment and systems within the QC building.
• Risk Assessment: Conduct risk assessments to identify potential validation issues and develop mitigation strategies to address them.
• Commissioning Support: Collaborate with the commissioning team to ensure a seamless transition from construction to operation, verifying that systems and equipment are installed correctly and function as intended.
• Audit Readiness Support: Prepare for and participate in internal and external audits related to validation activities, providing documentation and support as needed.
• Standard Operating Procedure: Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs in compliance with industry standards and cGMP.
• Participate on cross-functional teams to assist with Out of Specification (OOS), Deviation investigation, CAPA and Change Controls write-up.
• Coach junior team members.
• Perform Periodic Review for various validated systems including computerized systems, laboratory equipment, manufacturing equipment, infrastructure systems. Analyze information, draw the right conclusions based upon technical knowledge of the systems, and work effectively with different groups across site to determine status, gaps and corrective actions.
• Maintain up-to-date knowledge of validation requirements, practices, and procedures and coach other members of the team participating in validation activities.
• Maintain up-to-date knowledge of current GP (Good Practices, e.g. GMP/GLP) regulations, guidelines within North America (Health Canada, US Food & Drug Administration) and EU Eudralex.
• Ensure that projects are implemented in accordance within the agreed scope and timelines.

Basic Qualifications

• Strong leadership and keen personality highly motivated by growing a validation team and our Raleigh office.
• B.S. degree in engineering field or relevant equivalent.
• Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
• Minimum 7-10 years of direct work experience in a GMP/pharmaceutical environment, writing and executing commissioning and validation.
• Excellent knowledges of the Current 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 validation field.
• Strong relationship management, and organizational planning and project management skills, in addition to technical knowledge.
• Ability to demonstrate a sense of urgency, flexibility and accountability.
• Proficiency in using the Microsoft Office Suite.
• Flexibility to travel to the client site (in the Raleigh area) on a frequent basis.

Preferred Qualifications

• Prior experience in aseptic processing.
• Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA)
• Experience on determining Critical Quality Attributes and Critical Process Parameters.
• Familiarity with current industry standards cGMP, GLP
• Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.
• 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.

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