Validation (CSACSV) Consultant

Arc Technologies Group, LLC

Job Location:

Wichita, KS - USA

Monthly Salary: Not Disclosed

Posted on: 3 hours ago

Vacancies: 1 Vacancy

Job Summary

Job Title:Validation (CSA/CSV)Consultant

Location: Wichita KS
Job Type: Full-Time
Experience Level: 1-8 Years

Job Summary: We are seeking an experienced motivated and detail-oriented Validation Consultant to join our on-site team in Validation Consultant is responsible for planning executing and documenting validation and qualification activities for computerized systems laboratory systems manufacturing systems infrastructure and regulated processes within life sciences environments. This role works closely with Quality IT Engineering Manufacturing and business stakeholders to ensure systems are implemented and maintained in compliance with applicable regulatory requirements including FDA 21 CFR Part 11 GxP GAMP 5 and other global regulatory standards. The Validation Consultant provides technical and compliance expertise throughout the system lifecycle from requirements gathering and risk assessment through testing deployment and ongoing change management.

If you consider yourself a motivated and ambitious individual this will be the job for you.

Arc Technologies Group serves companies from growth startups to the Fortune 50 within Life Sciences and Healthcare.

Key Responsibilities:

Work on-site at ATG offices or Client offices or facilities on a daily basis
- This may involve a commute of up to 70 miles for extended periods of time
Lead validation and qualification activities for computerized systems applications equipment and infrastructure supporting regulated operations.
Develop and execute validation lifecycle deliverables including Validation Plans User Requirements Specifications (URS) Functional Specifications Risk Assessments IQ/OQ/PQ protocols Traceability Matrices and Validation Summary Reports.
Apply risk-based validation methodologies consistent with GAMP 5 FDA Computer Software Assurance (CSA) and industry best practices.
Facilitate requirements gathering sessions with business quality engineering laboratory and IT stakeholders.
Review system design documentation to ensure compliance data integrity and validation requirements are appropriately addressed.
Author review and execute validation test protocols and document test results deviations investigations and corrective actions.
Support implementation and validation of enterprise and manufacturing technologies including MES LIMS ELN ERP SCADA historian automation and laboratory systems.
Assess and document system impacts related to change controls software updates infrastructure modifications and periodic reviews.
Support regulatory inspections internal audits client audits and quality assurance reviews by providing validation documentation and compliance evidence.
Collaborate with project teams to develop validation strategies schedules and resource plans.
Ensure compliance with applicable regulations and standards including FDA EU GMP Annex 11 GAMP 5 WHO MHRA and other relevant guidance.Ensure software and computer systems meet quality safety and regulatory standards.
Identify validation risks and develop mitigation strategies to support successful project delivery.
Participate in client-facing meetings workshops assessments and strategic consulting engagements.
Understand and develop (SDLC) system/software development lifecycle and technical validation documentation. Execute validation testing where appropriate for IT and OT systems.
Produce or maintain accurate and up-to-date documentation for all IT and OT systems including user manuals standard operating procedures work instructions and validation protocols.
Provide advice/consultation on validation documentation and system/user requirements to achieve the best possible testing outcomes.
Think critically on test structures/design and ensure all client requirements are verified during validation.
Have attention to detail and apply patience when producing or reviewing documentation to identify and fix errors.
Put complex information into clear concise and accessible content/format for the intended audience. Ability to review edit and proofread content for accuracy clarity and consistency.
Research and gather information on systems/projects to fully understand operational function and use case. Includes working with SMEs and other teams to research and collect information needed for accurate documentation.
Determine and analyze the needs of end users to ensure that all documentation and requirements are clear and tailored to the system.
Learn and understand complex systems and topics quickly.
Perform risk assessments on various systems

Above & Beyond Responsibilities:

Understand client requirements business objectives & processes in addition to their technology and systems
Leverage your sales mindset to deepen customer relationships help transform services into comprehensive solutions and collaborate with the sales team to align goals with outcomes
Identify expansion opportunities to drive growth and ensure customer satisfaction through innovative IT/OT validation engineering and quality strategies
Support new technology implementation and provide assistance with technical issues strategic direction and financial analysis of projects/initiatives
Perform critical analysis of existing People Process and Technology state of clients
Work collaboratively with cross-functional teams including R&D quality assurance and manufacturing to deliver IT/OT solutions that meet business needs

Minimum Qualifications:

Bachelors degree in Engineering Computer Science Information Technology Life Sciences or a related technical discipline.
Minimum of 2 years of experience in computerized systems validation (CSV) computer software assurance (CSA) commissioning and qualification (C&Q) or a related validation discipline within the pharmaceutical biotechnology medical device or regulated healthcare industry.
Strong understanding of FDA 21 CFR Part 11 GxP regulations data integrity principles and GAMP 5 guidance.
Experience developing and executing validation lifecycle documentation including URS risk assessments IQ/OQ/PQ protocols traceability matrices and validation reports.
Experience supporting validation of GxP systems such as LIMS MES ERP QMS laboratory instruments manufacturing execution systems automation platforms or cloud-based applications.
Knowledge of software development lifecycle (SDLC) change management configuration management and quality management processes.
Demonstrated ability to interpret regulatory requirements and translate them into practical validation strategies.
Strong technical writing documentation analytical and problem-solving skills.
Excellent verbal and written communication skills with the ability to interact effectively with technical quality and business stakeholders.
Ability to manage multiple projects and priorities in a fast-paced consulting environment
Strong analytical and problem-solving skills excellent communication and interpersonal skills and the ability to work effectively in a team environment
Employees will be expected to commute up to 70 miles each way per day to various client sites if working at a long-term client facility. This is not a remote position
Employees must provide their own means of reliable transportation
BYOD is expected employees will be required to use a cell phone for work purposes including the installation of work communication tools such as MS Teams or Outlook
Must be authorized to work in the United States.
Candidates must be authorized to be employed in the U.S. by any employer.
- U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.
Must be available to work on-site in Wichita KS during standard business hours (roughly 8am-5pm Monday-Friday)
- This position is not remote; reliable daily transportation to our Wichita office and/or customer sites is required.
Requires routine sitting standing walking listening and talking
Acute mental and visual attention at all times
Ability to handle multiple projects while managing frequent interruptions
Requires moderate lifting or moving up to 100 pounds (lbs)

Experience with the follow items/areas are a plus but not required:

Experience with FDA Computer Software Assurance (CSA) methodology.
Knowledge of manufacturing automation platforms OT systems and industrial control systems.
Familiarity with cloud-hosted GxP systems and SaaS validation.
Previous consulting experience supporting multiple clients and projects.
Certifications such as ASQ Certified Quality Auditor (CQA) Certified Software Quality Engineer (CSQE) PMP or relevant validation certifications.
Experience supporting regulatory inspections and remediation initiatives.
Understand or have previous knowledge/experience in using document management systems and/or electronic execution systems with workflow and versioning capabilities.
Operational Technology foundational knowledge including but not limited to experience with IIoT PLCs HMIs SCADAs etc.
Familiarity with enterprise IT and OT cybersecurity architecture and/or frameworks
Have the ability to troubleshoot hardware software and network problems & to think critically to analyze and remediate root causes
ITIL Framework

Who we are:

Arc Technologies Group is a boutique professional services firm focused exclusively on life sciences; including pharmaceutical manufacturing biotech CDMO medical devices and animal health. We deliver technology that actually works for organizations operating in highly regulated environments. Our team brings deep experience in IT/OT convergence cybersecurity digital transformation and compliance-driven technology solutions across the entire life sciences technology space. We are proud to be an approved supplier in clients contingent workforce program and are committed to matching qualified professionals with meaningful contract opportunities at one of the worlds leading pharmaceutical companies.

Benefits:

401K
Short-term/Long-term disability
Medical/Dental/Vision may be available
Opportunities for professional development and career advancement
Collaborative & high-performance work environment

Arc Technologies Group employees are paid on an hourly basis; this is not a salaried position.

EEO & Employment Eligibility:

Arc Technologies Group LLC is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. ATG also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.

ATG is an E-Verify employer. This position requires work authorization in the United States.

Required Experience:

Contract

Job Title:Validation (CSA/CSV)ConsultantLocation: Wichita KSJob Type: Full-TimeExperience Level: 1-8 YearsJob Summary: We are seeking an experienced motivated and detail-oriented Validation Consultant to join our on-site team in Validation Consultant is responsible for planning executing and docume...