Computer Systems Validation Specialist Ii

Location: REMOTE

Overview:

The System Validation Specialists are responsible for executing computerized Systems Validation activities and generating relevant documents to establish and support a compliant state of regulated computerized systems.

Essential Job Functions:

• Actively lead validation activities for initial systems deployments and systems changes.
• Adapt, promote, and maintain the overall culture of quality and compliance within the organization. Assume responsibility for the alignment of daily decisions with the company culture and values, and with an incremental quality improvement mindset.
• Develop, or assist in development of, typical validation documentation, including Validation Plans and Summaries, URS/FRS, Design and Configurations, Test Plans and Summaries, Traceability Matrix, Functional Testing, User Acceptance Testing, system use SOP/WID, etc.
• Actively work with peer organizations, including IT, DevOps, User Community, Project management, and QA to gather necessary information and achieve desired project results. Adapt a team-work mindset to maintain a balance between potentially competing agendas and collaborate towards common goals.
• Work closely with the company QA personnel to ensure Systems Validation alignment and compliance with applicable procedures and current industry standards.
• Ensure continuous state of compliance of validated systems through exercising operational controls such as Change Management, Deviations, CAPA, Periodic Reviews, etc.
• Support, as needed, internal and external audits and audit readiness efforts, process and documentation improvement initiatives, and overall company improvements in systems compliance areas.
• Other duties as assigned.

Qualifications and Skills:

• Bachelor's Degree Preferred
• Life Sciences, Computerized Systems, Quality Assurance, or another relevant field of study is Preferred.
• A minimum of 3+ years of experience (Levels I-III) in comparable position within the pharmaceutical, biotech or CRO industry is required.
• Experience leading project validation efforts with minimal oversight is highly desired.
• Strong knowledge of computerized systems compliance and validation in Life Sciences regulated environments.
• General or expert knowledge of relevant regulations such as 21 CFR Part 11, EU Annex 11, Data Integrity, etc.
• Understanding of current industry trends such as FDA Computer Software Assurance and ISPE GAMP5 2nd Edition.
• Experience with Agile software development methodologies and validation practices during Agile development.
• Experience with systems utilizing cloud technologies is highly desired.
• Desire to learn and grow as a professional in this field.
• Ability to accept a high degree of responsibility for a positive outcome and act as a self-starter to drive projects towards completion.
• Excellent written and oral communication skills.
• Proficiency with MS Word and other tools.

What We Offer:

• Competitive salary
• Full Benefits
• 401k with generous matching
• Flexible vacation policy

About us:

Headquartered in Boston, MA, Invicro was founded in 2008 with the mission of improving the role and function of imaging in translational drug discovery and development across all therapeutic areas. Today, Invicro’s multi-disciplinary team provides solutions to pharmaceutical and biotech companies across all stages of the drug development pipeline (Phase 0-IV), all imaging modalities and all therapeutic areas, including neurology, oncology, and systemic and rare diseases. Invicro’s quantitative biomarker services, advanced analytics and AI tools, and clinical operational services are backed by the company’s industry-leading software informatics platforms, VivoQuant® and iPACS®, as well as their pioneering IQ-Analytics Platform, which includes AmyloidIQ, TauIQ and DaTIQ.

Invicro is an Equal Opportunity Employer. We maintain a drug-free work environment. All qualified applicants will receive consideration for employment without regard to actual or perceived race (and traits historically associated with race, including, but not limited to hair texture and protective hairstyles such as braids, locks, and twists), color, creed, religion, citizenship status, sex or gender (including pregnancy, childbirth and related medical conditions), parental status, sexual orientation, gender identity, gender expression (including transgender status), national origin, ancestry, age, marital status or protected veteran status and will not be discriminated against on the basis of physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, political affiliation or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Invicro does not accept unsolicited resumes from individual recruiters, third party recruiting agencies, outside recruiters or firms without an executed contract in place. We are not responsible for any fees related to resumes that are unsolicited or are received by Invicro. Such resumes will be deemed the sole property of Invicro and will be processed accordingly.

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