Strong Biotech CSV experience is mandatory. Candidates with primarily pharmaceutical or medical ... Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences ...
New
Strong Biotech CSV experience is mandatory. Candidates with primarily pharmaceutical or medical ... Bachelor's degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences ...
New
Data Scientist
Chicago, IL · On-site
$110K - $140K/yr
... biotechnology, diagnostics, and medical technology companies. You'll help generate evidence that ... Bachelors degree in Computer Science, Data Science, Biostatistics, Epidemiology, Public Health ...
Data Scientist
Chicago, IL · On-site
$110K - $140K/yr
... biotechnology, diagnostics, and medical technology companies. You'll help generate evidence that ... Bachelors degree in Computer Science, Data Science, Biostatistics, Epidemiology, Public Health ...
MES Consultant (Remote)
Chicago, IL · Remote
... the biotech, pharmaceutical and medical device industry. Our Focus EIS provides consulting ... Bachelors degree in a relevant area such as Operations, Computer Science, Engineering or Business ...
MES Consultant (Remote)
Chicago, IL · Remote
... the biotech, pharmaceutical and medical device industry. Our Focus EIS provides consulting ... Bachelors degree in a relevant area such as Operations, Computer Science, Engineering or Business ...
MES Consultant (Remote)
Chicago, IL · On-site +1
... the biotech, pharmaceutical and medical device industry. Our Focus EIS provides consulting ... Bachelors degree in a relevant area such as Operations, Computer Science, Engineering or Business ...
MES Consultant (Remote)
Chicago, IL · On-site +1
... the biotech, pharmaceutical and medical device industry. Our Focus EIS provides consulting ... Bachelors degree in a relevant area such as Operations, Computer Science, Engineering or Business ...
Science background or prior experience working in biotechnology and/or related life sciences ... Excellent mathematical, writing, verbal and computer skills * Ability to adapt to new tasks with ...
Science background or prior experience working in biotechnology and/or related life sciences ... Excellent mathematical, writing, verbal and computer skills * Ability to adapt to new tasks with ...
AI Scientist
Mundelein, IL · On-site
Well-funded AI Biotechnology Company PLEASE FOLLOW THE KENKOTECH PAGE AND CONNECT WITH THE JOB ... PhD in Machine Learning, Computer Science, Computational Biology, Bioinformatics, Statistics ...
AI Scientist
Mundelein, IL · On-site
Well-funded AI Biotechnology Company PLEASE FOLLOW THE KENKOTECH PAGE AND CONNECT WITH THE JOB ... PhD in Machine Learning, Computer Science, Computational Biology, Bioinformatics, Statistics ...
In this role, you will be a senior Solutions Consultant supporting pharma, biotech, medtech, and ... Bachelor's or Master's degree in Information Systems, Engineering, Computer Science, or a related ...
In this role, you will be a senior Solutions Consultant supporting pharma, biotech, medtech, and ... Bachelor's or Master's degree in Information Systems, Engineering, Computer Science, or a related ...
Investment Banking Associate - Biotechnology
Chicago, IL · On-site
$175K/yr
Science background or prior experience working in biotechnology and/or related life sciences ... Excellent mathematical, writing, verbal and computer skills * Ability to adapt to new tasks with ...
Investment Banking Associate - Biotechnology
Chicago, IL · On-site
$175K/yr
Science background or prior experience working in biotechnology and/or related life sciences ... Excellent mathematical, writing, verbal and computer skills * Ability to adapt to new tasks with ...
In this role, you will be a senior Solutions Consultant supporting pharma, biotech, medtech, and ... Bachelor's or Master's degree in Information Systems, Engineering, Computer Science, or a related ...
In this role, you will be a senior Solutions Consultant supporting pharma, biotech, medtech, and ... Bachelor's or Master's degree in Information Systems, Engineering, Computer Science, or a related ...
Business Analyst
Mundelein, IL · On-site
Preferred Qualifica * tionsExperience within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences indu * stry.Knowledge of GxP regulations, Computer System Validation (CSV), and ...
Business Analyst
Mundelein, IL · On-site
Preferred Qualifica * tionsExperience within the Pharmaceutical, Biotechnology, Medical Device, or Life Sciences indu * stry.Knowledge of GxP regulations, Computer System Validation (CSV), and ...
... biotechnology, laboratory, quality, validation, or regulated systems environments. * Bachelor's degree required; Life Sciences, Computer Science, Information Systems, or related field preferred.
... biotechnology, laboratory, quality, validation, or regulated systems environments. * Bachelor's degree required; Life Sciences, Computer Science, Information Systems, or related field preferred.
Payer Healthcare Data Scientist, Manager
$99K - $232K/yr
... Computer Science, Applied Mathematics, Biotechnology preferred - Prior consulting or advisory firm experience preferred - Contributing to commercial analytics product development - Familiarity with ...
Payer Healthcare Data Scientist, Manager
$99K - $232K/yr
... Computer Science, Applied Mathematics, Biotechnology preferred - Prior consulting or advisory firm experience preferred - Contributing to commercial analytics product development - Familiarity with ...
Senior Quality Engineer
Chicago, IL · On-site
... in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. * 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ ...
Senior Quality Engineer
Chicago, IL · On-site
... in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. * 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ ...
Senior Quality Engineer
Chicago, IL · On-site +1
... in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. * 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ ...
Senior Quality Engineer
Chicago, IL · On-site +1
... in Computer Science, Software Engineering, Informatics, Biomedical, or relevant engineering disciplines. * 5+ years experience in FDA regulated domain (e.g. medical device, pharma, biotech) * 3+ ...
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL · On-site
$70K - $100K/yr
CQV (Commissioning, Qualification, Validation) * or GMP-regulated environments (Pharma / Biotech ... Computer System Validation, CSV Engineer, FDA Compliance, GMP Engineer Please visit our careers ...
Validation Engineer (CQV, GMP, Life Sciences)
Chicago, IL · On-site
$70K - $100K/yr
CQV (Commissioning, Qualification, Validation) * or GMP-regulated environments (Pharma / Biotech ... Computer System Validation, CSV Engineer, FDA Compliance, GMP Engineer Please visit our careers ...
... computer system validation in a life sciences environment, including pharmaceutical, biotechnology, medical device, or clinical environments * Experience leading validation deliverables for GxP ...
... computer system validation in a life sciences environment, including pharmaceutical, biotechnology, medical device, or clinical environments * Experience leading validation deliverables for GxP ...
Solution Architect
Mundelein, IL · On-site
$64.25 - $84.75/hr
Required Qualifica * tionsBachelor's degree in Computer Science, Information Systems, Engineering ... Preferred Qualifica * tionsExperience within the Pharmaceutical, Biotechnology, Medical Device, or ...
Solution Architect
Mundelein, IL · On-site
$64.25 - $84.75/hr
Required Qualifica * tionsBachelor's degree in Computer Science, Information Systems, Engineering ... Preferred Qualifica * tionsExperience within the Pharmaceutical, Biotechnology, Medical Device, or ...
Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical ... or biotechnology). * Advanced Computer Skills: Ability to perform the most complex computer tasks ...
Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical ... or biotechnology). * Advanced Computer Skills: Ability to perform the most complex computer tasks ...
Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical ... or biotechnology). * Advanced Computer Skills: Ability to perform the most complex computer tasks ...
Bachelor's degree in Engineering, Life Sciences, Computer Science, or a related technical ... or biotechnology). * Advanced Computer Skills: Ability to perform the most complex computer tasks ...
... biotechnology, medical device, and life sciences organizations. * Develop target operating models ... Support Computer System Validation (CSV) activities. * Define risk-based validation approaches.
New
... biotechnology, medical device, and life sciences organizations. * Develop target operating models ... Support Computer System Validation (CSV) activities. * Define risk-based validation approaches.
New
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Posted 2 days ago
New
Job description
Locations: Piscataway, NJ – 2 Openings | Chicago, IL
Position : Computer System Validation (CSV) Consultants – 3 Openings
Work Arrangement: 100% Onsite – 5 Days/Week
Employment: Contract-to-Hire
Work Arrangement: 100% Onsite – 5 Days/Week
Employment: Contract-to-Hire
Interview : Video
Linked In must and candidate must be local to IL or NJ
Position Overview
Client is seeking Computer System Validation (CSV) Consultants to support validation activities within a highly regulated biotechnology environment. Candidates must have a strong, hands-on Biotech CSV background and experience validating laboratory, manufacturing, engineering, and enterprise computerized systems.
Strong Biotech CSV experience is mandatory. Candidates with primarily pharmaceutical or medical-device CSV backgrounds will not be considered.
The consultants will partner closely with Quality, IT, Laboratory, Manufacturing, and system owners to ensure computerized systems are appropriately validated and maintained in accordance with GxP and applicable regulatory requirements.
Responsibilities
- Plan, author, execute, and maintain CSV documentation including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Design Specifications (DS), IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
- Perform CSV activities for laboratory instruments, engineering/manufacturing equipment, and enterprise applications.
- Validate systems including LIMS, SAP, CMMS/calibration platforms, and other GxP-regulated applications.
- Partner with system owners, Quality, IT, Laboratory, and Manufacturing teams to maintain systems in a validated state through change control and periodic reviews.
- Conduct risk assessments and data-integrity assessments aligned with ALCOA+ principles.
- Support audits, inspections, CAPAs, deviations, and remediation activities related to computerized systems.
- Apply GAMP 5 and risk-based validation principles throughout the system lifecycle.
- Support validation activities involving Caliber LIMS, SAP QM/MM/PP, BMRAM or comparable CMMS/calibration systems where applicable.
Required Qualifications
- 5+ years of Computer System Validation experience within a GxP-regulated environment.
- Strong, demonstrable CSV experience specifically within Biotechnology/Biotech environments – REQUIRED.
- Hands-on experience authoring and executing IQ/OQ/PQ protocols.
- Strong working knowledge of 21 CFR Part 11, EU Annex 11, GxP, GAMP 5, and risk-based validation.
- Experience validating at least two of the following:
- Laboratory instruments
- Manufacturing/engineering equipment
- LIMS
- SAP
- CMMS/calibration systems
- Experience working cross-functionally with Quality, IT, Laboratory, Manufacturing, and technical SMEs.
- Bachelor’s degree in Life Sciences, Engineering, IT, or equivalent relevant life-sciences laboratory experience.
About Digitive
Sourced by ZipRecruiter
Industry
Recruiting and staffing services
Company size
11 - 50 Employees
Headquarters location
Walnut Creek, CA, US
Year founded
2019