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 Toronto, Canada, the validation specialist/engineer will be responsible to support and lead the validation requirements for client projects, especially in terms of documentation:
- 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.
- Provide technical input with respect to Standard Operating Procedures (SOP) development. Revise or develop SOPs as required to assure that all needs are addressed, and compliance and industry standards are incorporated.
- 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.
- Perform equipment risk assessments to assess impact of system functionality and control on product quality and troubleshoot equipment/system when errors occur to provide recommended corrective and/or preventive actions (CAPA) to client.
- Participate on cross-functional teams to assist with Out of Specification (OOS), Deviation investigation, CAPA and Change Controls write-up.
- Coordinate validation activities between the Laporte team and client 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.
- 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.
- S. degree in mechanical or process engineering field.
- Prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
- 3-5 years of direct work experience in a GMP/ pharmaceutical environment, writing and executing commissioning and validation.
- 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) 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.
- 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.
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.