Validation Specialist III

Job summary   Responsible for supporting the IT team in all aspects of system validation and verification. The successful candidate will have a background in both business and IT and will have an extensive understanding of the validation practices and software development life cycle in a regulated environment. We're looking for a responsible, articulate and motivated Validation Specialist to manage and create validation deliverables for Prolacta's system implementations. Must be able to manage tradition waterfall projects as well as Agile sprint based projects.   Primary Duties and Responsibilities   Applies thorough understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOPcurriculum, routine project procedures, project management, and other training as appropriate. Writes, executes, and summarizes qualification and validation reports Plans for execution of validation protocols and studies Trains personnel on system operation Uses technical problem-solving techniques for solving basic non-conformance or identifying the potential root causes Performs validations and studies in a safe, compliant manner Authors quality related documents such as IOPQ, Validation Plan, Test Plan, Test Scripts as needed Supports process development and/or validation Performs risk assessment activities Collaborate with business teams to ensure updates to SOPs/ Training manuals are completed as needed Responsible for planning, scheduling, and leading validation assignments. Must demonstrate competent and effective planning, coordination, and organizational skills. Review and asses change control requests with potential impact to validated state of validation elements, as applicable. Ensure backlogs are updated, prioritized regularly and are resolved in a timely manner while adhering to Prolacta SOPs and change control procedures Participate in internal or external assessments or audits, as required. Support process with timely closure of observations/audit items. Reviews and defines project requirements to ensure they are in line with business objectives Works closely with the Prolacta Quality team to insure compliance with regulatory requirements Participates in, and conducts team review throughout the life cycle of the project Lead small to mid-size projects independently as a lead Validation Specialist     Job Requirements and Qualifications   Must have 5+ years of experience, proficiency, and leadership in pharmaceutical/biotech validation elements, including the writing and executing of protocols and standard operating procedures. Must have a strong comprehension of the operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus. Must have extensive cross-functional team experience. Must also have demonstrated ability to produce results in a cross-functional team environment (including technical and non-technical work) with minimal supervision. Must demonstrate leadership skills. Must possess excellent technical writing, communication, and organizational skills. Must display a solid technical understanding of the validation element principles and procedures and scheduling a series of project technical and project management overviews without assistance. Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project. Must have sound industry knowledge, project proficiency, and autonomy expected. Must be able to lead and implement optimization of processes within the department or the site. Should have advance experience and proficiency in problem analysis and resolution, successful track record of analyzing complex technical problems, and demonstrates good troubleshooting and decision-making abilities. Ability to organize and present technical and project management overviews without assistance to upper-management. Requires BA or BS degree preferably in the engineering or science field Experience with Manufacturing systems, Lab Information systems, ERP systems is a plus Prior experience interacting with the FDA and other regulatory agencies is a plus.
Salary Range: NA
Minimum Qualification
5 - 7 years

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