Vacancy has expired
|Job Ref:||df55fce52||Employer:||Direct Solutions - Canada||Country:||Canada||County/State:||Ontario||City:||Guelph||Address:||Post Date:||16/10/2016 23:17|
Technical writer experienced in Pharmaceutical and Biotechnology Industries with solid GMP and regulatory experience. Expertise in equipment and computer validations for packaging process, project tracking and any deviations or additional documentation requirements arising from changes to project scope, in addition to writing and execution of project deliverables. Additionally will assist in other validation projects as needs dictate. Responsibilities: · Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis · Implements policies and procedures to validate/qualify equipment, systems, and processes in accordance with regulatory requirements and company manufacturing standard · Generate new specifications based on new regulations required by the implementation of a new packaging proces · Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria · Interact with all levels of management and staff to manage and facilitate the validation process from inception to completion by enlisting cooperation, support and approval for identified validation projects · Plan, schedule and organize validation projects for new and existing areas, including manufacturing processes, plant systems, cleaning and equipment · Prepares and coordinate qualification activities · Execute and documentation of validation activities · Communicate with the staff and management on ways of implementing plans and recommendations · Ensure accuracy and integrity of protocols, reports and documentation generated to meet regulatory authorities Education/Experience: · Engineering or science degree from ABET accredited university program. · Minimum of two years related experience in packaging equipment and systems validation within a manufacturing environment. · Experience in a FDA regulated environment. Additional Responsibilities: · Excellent attitude, attention to detail and interpersonal relationship skills. · Interact with a variety of departments such as Validation, Engineering, Project Management and Quality Assurance, among others. · Provide on-site support to the client. · Participation in client project meetings, as required. · Identify new work opportunities and submit proposals. Work Environmental & Physical Demands: · Must be willing and able to work additional or off hours on projects as required to satisfy the client's deadlines and minimize production schedule impact. · Excellent organizational skills. · Self-disciplined. · Capable of working independently and within a team framework. · Sensitive to client's needs and demands. · Ability to work within project budget and schedule requirements.
RPA Engineering is a professional engineering consulting firm offering all major engineering discipline services, including unique capabilities in Machine Design, Controls, High Stress Piping Analysis, and Commissioning and Validation Services. Operating for more than 26 years, RPA provides high quality, cost-effective engineering and design services from its Wyomissing, Pennsylvania headquarters, five regional offices, and onsite client services. For more information, visit RPA Engineering.