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Senior Validation Engineer

75% Flex

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

Connecticut (USA), Illinois (USA)

Offer summary

Qualifications:

Bachelor's degree in scientific or engineering discipline, 4+ years experience in computer validation and Data Integrity compliance, Extensive knowledge of GMP requirements, quality trends, and pharma application systems.

Key responsabilities:

Perform risk assessments related to 'Data Integrity'
Investigate deviations and suggest remediation in CGMP operations
Collaborate with external/internal partners for DI assessments
Work independently to solve problems and qualify systems within scope, budget, and time constraints
Expertise in system qualification, validation, CFR21 Part 11 compliance, and regulatory requirements

Katalyst HealthCares & Life Sciences Pharmaceuticals SME https://www.katalysthls.com/

51 - 200 Employees

See more Katalyst HealthCares & Life Sciences offers

Job description

Your missions

Responsibilities & Requirements:

Multiple Positions and systems are available: SDMS/Labx/Veeva RIM/SDMS/ValGenesis/Labware LIMS.
Perform "Data Integrity” related- risk assessments.
Deviation investigations suggest implementing remediations in CGMP operations.
Performs Data Integrity compliance/impact assessments, risk assessments, and create short executive summary reports.
Collaborates with the external partner or internal site to assess their DI maturity state and document the results of the assessment.
Very knowledgeable in current and emerging GMP requirements and quality trends (e.g., 21 CFR Part 11, 210, 211, 820).
Work independently on and successfully solve problems and complete/qualify a system within given constraint of scope budget, and time.
Demonstrate expertise in system qualification, application validation and CFR21 Part 11 compliance, and regulatory compliance governing the pharma industry.
Bachelor's degree in scientific or engineering discipline along with 4 plus years of experience in the field of computer validation, Data Integrity compliance.
The ideal candidate will have significant experience in pharma application systems supporting the labs and production such as LIMS, ELN, document management and quality systems.
Demonstrate expertise in system qualification and regulatory compliance and internal requirements employing regulatory guidance and industry standards.
Must have excellent verbal communication and technical writing skills.
Experience with all pertinent industry best practices (e.g., ISPE GAMP5) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Working knowledge of the development of protocols for the validation of complex computer systems.
Significant experience using MS Office 365 suite of applications. (PowerPoint, Excel, Word, Project, etc.)

Required profile

Experience

Level of experience: Mid-level (2-5 years)

Industry :

Pharmaceuticals

Spoken language(s):

English

Check out the description to know which languages are mandatory.

Hard Skills

Data Integrity Knowledge of Pharma Industry Regulatory Compliance Technical Writing Microsoft 365 Administration

Soft Skills

Verbal Communication in Japanese
Problem Solving
Independence

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