Preparedness today, safer tomorrow. Emergent is a leading public health company that delivers protective and life-saving solutions to communities around the world. Here, you will join passionate professionals where our culture is informed by our values and commitment to protecting and saving lives.Job Summary This role is responsible for supporting the validation effort and, where required leading projects to ensure that equipment, facilities, utilities, processes and computer systems utilized in the manufacture of product are validated for intended use. The role will also be responsible for providing leadership and technical guidance aimed at implementing best practices and improving the overall performance of the validation team and quality processes. Responsibilities <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Review, assess and approve (as applicable) CSV related materials for all local and global Computerized System projects</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Apply Global GxP requirements as part of a pragmatic validation strategy for computerized systems</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Establish and enhance the relationships between IT, validation, and business units, through collaboration, respectful challenge, and ability to strongly support QA decisions</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Continually monitor the effectiveness of the DI/CSV program, and recommend optimization opportunities as identified</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Participate, as needed, in audits of DI/computerized systems, both internal and external.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Deliver CSV education and awareness, to enhance site level awareness of Data Integrity requirements, and associate accountabilities</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">QA owner and SME for Data Integrity Assessments/Computer System Risk Assessments, Data Stream Mapping, Remediation Design, Report Creation.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Participate in investigations and corrective actions of data related incidents and report open DI vulnerabilities to site leadership</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Responsible for process related activities including the development of validation strategies, the estimation of validation timelines and resource requirements, the generation and approval of the project validation plans, the development of robust and efficient validation test protocols and reports, for new and existing processes. </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Working with the cross functional teams in the development and execution of validation activities associated with new equipment, processes or system upgrades.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Participating in project activities including design of systems and equipment to ensure that they comply with applicable regulations & International Standards.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Providing technical input into all phases of the validation lifecycle, i.e. from design through to the commissioning and qualification execution phase and through to validation maintenance.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Review and approval of documents prepared by the validation team, other departments and contractor organizations as required.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Resolving and assisting in the closure of deviations initiated during validation activities or as related to critical process parameters.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Assisting in the implementation of any existing Validation program to ensure continued compliance to the necessary regulations.</li> </ul> The above statements are intended to describe the general nature of work performed by those in this job. It is not an exhaustive list of all duties, and other duties may be assigned. Education, Experience & Skills Requirements <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">BS Engineering/Chemistry/Microbiology or related field.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Minimum 5-7 years related industrial experience in the area of validation.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Expert knowledge of validation principles and concepts.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Demonstrated ability to manage complex validation projects in a fast paced environment is required.</li> </ul> Skills <ul style="margin-bottom:0.0in;margin-top:0.0px"> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Possesses Strong knowledge of CSV/GAMP, 21 CFR Part 11, Annex 11, Project Life Cycle and quality systems, cGMP, GDP and FDA/EMEA guidelines and proven ability to apply guidelines to all aspects of validation activities.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">Possesses strong knowledge of engineering and related practices, including governmental regulations – ISPE, EU, 21CFR 210, 211, Part 11. </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;font-size:12.0pt;font-family:'Times New Roman', serif">Experience with Aseptic/Sterile Manufacturing and /or Qualification experience within the pharmaceutical or biopharmaceutical industries is preferred.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Experience with systems such as Controlled Temperature units, Critical Utilities, Facilities, and equipment, preferably used in a GMP environment.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Demonstrates success in technical proficiency, creativity, and collaboration with others and independent thought. </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Makes decisions exercising judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Ensure alignment and communication of issues and strategies. </li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Excellent attention to detail, with an ability to work to very tight schedules.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Excellent communication and organisational skills.</li> <li style="margin:0.0in 0.0in 0.0in 0.0px;line-height:normal;font-size:11.0pt;font-family:Calibri, sans-serif">Adaptable and flexible.</li> </ul>There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate. As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our <a href="http://ebsi.com/?q=node/138">Privacy Policy</a>.

Specialist I, QA Validation (Winnipeg, MB, CA, R3T 5Y3) @ Emergent Biosolutions

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