Senior CSV Configuration Specialist - Location Negotiable
Do you want to work where scientific innovation meets leading-edge technology? Join Accenture Scientific Informatics Services and help our clients apply digital technologies to revolutionize scientific and laboratory processes.
Accenture Scientific Informatics Services combines the scientific and laboratory informatics expertise of LabAnswer with Accenture's strategic and business consulting capabilities, industry platforms, innovation approach and global scale to help transform how scientific and laboratory processes are conducted across a variety of industries-helping make them faster, more efficient and more effective than ever before.
Leveraging digital technologies such as automation, artificial intelligence, Internet of Things, analytics and cloud, in combination with a fundamental redesign of the scientific user experience, Accenture Scientific Informatics Services helps organizations better capture, manage, integrate and analyze complex scientific data. This can improve the discovery and manufacturing of new products, improve quality, ensure compliance, reduce time to market and improve operational efficiency.
As an Accenture Scientific Informatics Services Specialist you will be exposed to the technologies and processes that many leading U.S. companies and government agencies utilize. We offer a generous compensation package consisting of salary, bonuses and benefits.
We are looking for a Senior Validation Lead. This position will be responsible for defining validation requirements, developing systems validation documentation, generating and executing test protocols and summarizing validation activities in reports. The selected individual will play a key role throughout the system development life cycle (SDLC), from validation of complete new systems on projects through qualification of changes for existing systems, to assure that all critical systems remain in a validated state. Their focus will be on computerized systems in support of the Pharmaceutical and Biotechnology industry.
- Assists in the management of computer systems validation
- Assists in defining validation strategy
- Generation of validation documentation, which include validation plans, audit plans, requirement specifications, test plans, IQ, OQ and PQ protocols, test cases/scripts, traceability matrices and validation reports
- Development and execution of functional testing, both manual and automated
- Conducting risk assessments and periodic audits of systems and software development activities
- Ensures all systems and software are in compliance with GMP, GLP, GCP, QSR, 21 CFR Part 11, ICH guidelines, and GAMP guidelines
- Assists in the management of controlled documents
- Responsible for training related to validation projects, client-specific software applications and SOPs
- Development of SOPs in support of quality systems and software development
+ Basic qualifications
- Prior validation experience working with Laboratory Informatics Systems, such as LIMS, CDS, ELN
- Strong theoretical knowledge of Computer System Validation
- BS in Computer Science, Laboratory Science (e.g., Biology, Chemistry, Biochemistry etc.), and/or Engineering
- 5 + years of validation experience in the biotechnology, pharmaceutical or clinical
- Working knowledge of GMP, GLP, GCP, QSR, GAMP and 21 CFR Part 11 as they relate to computer systems validation
- Knowledgeable in applying SOPs, work instructions and regulatory requirements to the System Development Life Cycle
- Experience with testing and supporting manufacturing, laboratory and clinical applications as well as business systems is helpful. (i.e. SaaS cloud, LES, MES, PLC, SCADA, LIMS, CDAS, CDMS, EDC, CTMS, SAP)
- Excellent written and verbal communication skills
- Ability to work as a supportive team member in a large scale project
- Ability to travel 50% (on average, annually)
- Proficiency with MS Word, Excel, PowerPoint and Visio
- Excellent and proactive communication skills both written and verbal
- Service attitude paired with a strong desire to succeed and grow
- Positive attitude and strong critical thinking skills
- Problem-solver and self-starter who thrives in team environment
Applicants for employment in the US must have work authorization that does not now or in the future require sponsorship of a visa for employment authorization in the United States and with Accenture.
Candidates who are currently employed by a client of Accenture or an affiliated Accenture business may not be eligible for consideration.
Accenture is an EEO and Affirmative Action Employer of Females/Minorities/Veterans/Individuals with Disabilities.
Equal Employment Opportunity
All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status or any other basis as protected by federal, state, or local law.
Job candidates will not be obligated to disclose sealed or expunged records of conviction or arrest as part of the hiring process.
Accenture is committed to providing veteran employment opportunities to our service men and women.
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