QA CSV/CQV Specialist

Job Description:
Seeking a talented and driven individual to join our Quality Assurance Computer System Validation (CSV) team, for the launch of a new building at Rahway NJ site. The candidate will play a pivotal part in ensuring the compliance and efficiency of computerized systems within the new facility, contributing to the successful implementation of our operations. This role presents an exciting opportunity to be part of a dynamic team and make a significant impact on the quality and reliability of our systems in a cutting-edge environment.
Responsibilities:

• Responsible for providing quality assurance support and oversight for commissioning/qualification of the facilities, equipment and instruments in the manufacturing facility and the associated laboratories.
• Responsible for providing quality oversight for automation systems for new facilities and upgrades to the existing facilities. Automation systems include systems such as Delta V, Client, Client & SCADA.
• Responsible for quality oversight cleaning and thermal validation.
• Responsible for the review and approval of SOPs.
• Provide Quality support for Environmental Area and Utility Performance Qualification Plans, Protocols and Reports.
• Quality ownership for new capital projects which can include new facility associated utilities and equipment.
• Leading routine process support and improvement activities.
• Providing Quality guidance for daily production support, projects, deviations, and changes.

Requirements:

• B.S. and/or M.S. degree in an appropriate Life Science, Computer Science, Information Technology or Engineering discipline.
• t least 10-15 years of experience working in a Pharmaceutical/Biotechnology industry experience working in a health authority regulated (e.g. GxP) environment.
• Industry experiences including computer system validation, System Life Cycle (SLC), software validation, and/or Quality Assurance functions.
• High level of expertise and exposure with agency regulations, such as 21 CFR Part 11
• Part 58, Part 210, Part 211 from the US Food and Drug Administration.
• Experience in creation, execution, and reviewing change control document.
• Strong interpersonal and written/oral communication skills.
• bility to quickly process complex information and often make critical decisions with limited information.
• Proficient in applying process excellence tools and methodologies
• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.
• Good written and verbal communication skills are required.
• bility to work with others in a team environment.
• Experience authoring and executing documentation including but not limited to: Batch Records, SOPs, Work Instructions, CQV protocols.
• Experience with TrackWise, CMMS and Maximo
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint)
• Experience working in an aseptic manufacturing facility, quality testing facility, quality assurance, or manufacturing compliance.
• Demonstrated ability to work independently, drive effective communication, coordination and collaboration across relevant cross functional groups to establish a strong, compliant CQV program.

Skills:

• Experience with Project Management principles
• Expertise with end-to-end data governance
• Knowledge of published regulatory agency data integrity, computer software assurance