... Pharma / Biotech / MedTech). * Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports. * Strong knowledge of 21 CFR Part 11 and EU ...
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... Pharma / Biotech / MedTech). * Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports. * Strong knowledge of 21 CFR Part 11 and EU ...
Computer System Validation
Wilmington, DE · On-site
$125K - $150K/yr
Must Have Technical/Functional Skills • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
Computer System Validation
Wilmington, DE · On-site
$125K - $150K/yr
Must Have Technical/Functional Skills • 810 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech). • Hands-on experience with ...
System Engineers
Newark, DE · On-site
System Engineer Location: Newark, DE Long Term Contract Job Overview: We are seeking highly skilled ... User Needs to Design Validation: Work cross-functionally to trace user needs to design validation ...
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System Engineers
Newark, DE · On-site
System Engineer Location: Newark, DE Long Term Contract Job Overview: We are seeking highly skilled ... User Needs to Design Validation: Work cross-functionally to trace user needs to design validation ...
LabWare LIMS-LES Developer
Port Penn, DE · On-site
... Perform system testing, validation, and documentation according to defined protocols. • ... Preferred : • Experience with LabWare Pharma Template. • Knowledge of SQL and relational ...
LabWare LIMS-LES Developer
Port Penn, DE · On-site
... Perform system testing, validation, and documentation according to defined protocols. • ... Preferred : • Experience with LabWare Pharma Template. • Knowledge of SQL and relational ...
John Snow Labs is the developer of Spark NLP - the world's most widely used NLP library in the ... Ensure models are validated for issues like bias, overfitting, and concept drift to ensure ...
John Snow Labs is the developer of Spark NLP - the world's most widely used NLP library in the ... Ensure models are validated for issues like bias, overfitting, and concept drift to ensure ...
John Snow Labs is the developer of Spark NLP - the world's most widely used NLP library in the ... Ensure models are validated for issues like bias, overfitting, and concept drift to ensure ...
John Snow Labs is the developer of Spark NLP - the world's most widely used NLP library in the ... Ensure models are validated for issues like bias, overfitting, and concept drift to ensure ...
Electro-Mechanical Controls Engineer (Automation Engineer Lead Analyst) - Express Scripts
Newark, DE · On-site
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Electro-Mechanical Controls Engineer (Automation Engineer Lead Analyst) - Express Scripts
Newark, DE · On-site
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Electro-Mechanical Controls Engineer (Automation Engineer Lead Analyst) - Express Scripts
Newark, DE · On-site
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Electro-Mechanical Controls Engineer (Automation Engineer Lead Analyst) - Express Scripts
Newark, DE · On-site
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Support installation, validation, expansion, and upgrade projects for automation equipment and ... For this position, we anticipate offering an hourly rate of 38 - 63 USD / hourly, depending on ...
Lead iOS Software Engineer
Wilmington, DE · On-site
Develop infrastructure for validating AI-powered features including ML model outputs ... Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a ...
Lead iOS Software Engineer
Wilmington, DE · On-site
Develop infrastructure for validating AI-powered features including ML model outputs ... Hourly employees are not eligible for paid time off unless required by law. Hourly employees on a ...
Associate Director, Technical Operations (Drug Substance)
Wilmington, DE · On-site
$142.40 - $224.10/hr
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Manufacturing Process Validation * Operational Acceptance Testing (OAT) * People Leadership
Associate Director, Technical Operations (Drug Substance)
Wilmington, DE · On-site
$142.40 - $224.10/hr
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Manufacturing Process Validation * Operational Acceptance Testing (OAT) * People Leadership
Director, Statistical Programming Wilmington, Delaware, United States of America LGY_CDPR - Pro[...]
Wilmington, DE · On-site
$165.10 - $247.64/hr
Develop and validate technical programming specifications for analysis datasets using Alexion or ... The annual base pay (or hourly rate of compensation) for this position ranges from* $165,095.20 ...
Director, Statistical Programming Wilmington, Delaware, United States of America LGY_CDPR - Pro[...]
Wilmington, DE · On-site
$165.10 - $247.64/hr
Develop and validate technical programming specifications for analysis datasets using Alexion or ... The annual base pay (or hourly rate of compensation) for this position ranges from* $165,095.20 ...
Data & AI Senior Engineer - 90405345 - Remote
Wilmington, DE · On-site +1
$118K - $156K/yr
Experience embedding data quality validation, schema enforcement, lineage tracking, and policy-as ... The salary/hourly range is $86,500.00 - $111,996.00. Pay is based on several factors including but ...
Data & AI Senior Engineer - 90405345 - Remote
Wilmington, DE · On-site +1
$118K - $156K/yr
Experience embedding data quality validation, schema enforcement, lineage tracking, and policy-as ... The salary/hourly range is $86,500.00 - $111,996.00. Pay is based on several factors including but ...
Data & AI Senior Engineer - 90405345 - Remote
Wilmington, DE · On-site +1
$118K - $156K/yr
Experience embedding data quality validation, schema enforcement, lineage tracking, and policy-as ... The salary/hourly range is $86,500.00 - $111,996.00. Pay is based on several factors including but ...
Data & AI Senior Engineer - 90405345 - Remote
Wilmington, DE · On-site +1
$118K - $156K/yr
Experience embedding data quality validation, schema enforcement, lineage tracking, and policy-as ... The salary/hourly range is $86,500.00 - $111,996.00. Pay is based on several factors including but ...
Associate Director, Technical Operations (Drug Substance)
Wilmington, DE · On-site
$142.40 - $224.10/hr
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility. * Demonstrated ...
Associate Director, Technical Operations (Drug Substance)
Wilmington, DE · On-site
$142.40 - $224.10/hr
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility. * Demonstrated ...
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility. * Demonstrated ...
Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute ... Eight or more (8+) years working in a cGMP biological, vaccine or pharma facility. * Demonstrated ...
The role serves as the primary (Key Super User bridge between Operations, Engineering, and IT to ... GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and ...
The role serves as the primary (Key Super User bridge between Operations, Engineering, and IT to ... GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and ...
The role serves as the primary (Key Super User bridge between Operations, Engineering, and IT to ... GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and ...
The role serves as the primary (Key Super User bridge between Operations, Engineering, and IT to ... GMP knowledge required (21 CFR Part 11) - understanding of Computer System Validation (CSV) and ...
... validated parameters. * Conduct and document in-process checks (pH, weight/volume, torque, visual ... Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS. * Bachelor ...
... validated parameters. * Conduct and document in-process checks (pH, weight/volume, torque, visual ... Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS. * Bachelor ...
Senior Production Operator - OSD Pharma Tablet Compression
Middletown, DE · On-site
$15.75 - $19/hr
... validated parameters. * Conduct and document in-process checks (pH, weight/volume, torque, visual ... Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS. * Bachelor ...
Senior Production Operator - OSD Pharma Tablet Compression
Middletown, DE · On-site
$15.75 - $19/hr
... validated parameters. * Conduct and document in-process checks (pH, weight/volume, torque, visual ... Collaborate with QA, QC, MSAT/Process Engineering, Supply Chain, Facilities, and EHS. * Bachelor ...
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Full-time
Re-posted 3 days ago
Job description
COMPUTER SYSTEM VALIDATION LEAD
Wilmington, DE
Fulltime
10+ years of experience
Must Have Technical/Functional Skill
• 8–10 years of experience in Computer System Validation (CSV) in regulated (GxP) environments (Pharma / Biotech / MedTech).
• Hands-on experience with validation deliverables: VMP/VP, URS/FS/DS, risk assessments, RTM, IQ/OQ/PQ protocols and reports.
• Strong knowledge of 21 CFR Part 11 and EU Annex 11; ALCOA+ data integrity principles.
• Experience validating SDLC/CSV across system types (e.g., LIMS, MES, QMS, ERP, DMS, Lab instruments, cloud/SaaS applications).
• Familiarity with GAMP 5 and risk-based validation approach.
• Ability to review vendor documentation, perform supplier assessments, and leverage vendor testing.
• Working knowledge of change control, deviation management, CAPA, and periodic review.
• Good documentation practices; strong stakeholder management and communication skills.
Roles & Responsibilities
• Lead and execute end-to-end CSV activities across the validation lifecycle, ensuring compliance with applicable regulations and internal quality procedures.
• Perform system impact and risk assessments; define validation strategy, scope, and approach (risk-based).
• Author/review validation documentation (VP/VMP, URS, FS/DS, RA, RTM, protocols, reports) and ensure traceability from requirements to testing.
• Develop and execute IQ/OQ/PQ (or equivalent) test scripts; collect and review objective evidence; manage deviations and re-testing.
• Support system release and go-live readiness; ensure security, access control, audit trails, and electronic records/signature controls meet Part 11/Annex 11 expectations.
• Coordinate with IT, Quality, vendors, and business SMEs; review supplier documentation and leverage vendor testing where appropriate.
• Support change control activities (impact assessment, regression testing recommendations, validation closure) and periodic review/maintenance activities.
• Prepare for and support internal/external audits and inspections; respond to auditor queries and contribute to CAPA actions.
• Mentor junior CSV team members; contribute to process improvements, templates, and best practices.