CrawlJobs Logo

Csv Specialist / Csv Consultant - Mes Validation

India, Hyderabad · Job Posted June 14, 2026
Apply Position
Job Link Share

Job Responsibility

  • Validation Plan and Validation Risk Assessment
  • Requirement Traceability Matrix
  • IQ, OQ, and PQ protocols
  • Executed test scripts with objective evidence
  • Deviation, defect, and issue logs with closure evidence
  • Validation Summary Report
  • Approved validation package supporting MES go-live readiness

Requirements

  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail

Nice to have

  • Werum PAS-X
  • Rockwell PharmaSuite
  • Siemens Opcenter Execution Pharma
  • Emerson Syncade
  • MasterControl Manufacturing Excellence
  • Any other pharma MES platform

Looking for more opportunities?

Search for other job offers that match your skills and interests.

Similar Jobs for

Csv Specialist / Csv Consultant - Mes Validation

8 matching positions

CSV Specialist / CSV Consultant - MES Validation

We are looking for experienced CSV resources to support a Manufacturing Executio...
Location
Location
India , Hyderabad
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience in Computer System Validation (CSV)
  • 3 to 5 years of experience in pharmaceutical, biotech, life sciences, or regulated manufacturing environments
  • 3+ years of hands-on experience with MES validation and GxP validation lifecycle
  • Good understanding of 21 CFR Part 11, EU Annex 11, ALCOA+, and data integrity expectations
  • Experience in validation document preparation, review, execution, and approval workflows
  • Ability to coordinate with QA, Manufacturing, IT, Automation, and vendor teams
  • Strong documentation discipline and attention to detail
Job Responsibility
Job Responsibility
  • Support validation planning, impact assessment, risk assessment, and validation strategy for the MES scope
  • Prepare and review validation documents such as Validation Plan, URS, FRS, DS, RTM, IQ, OQ, PQ, and Validation Summary Report
  • Prepare, review, and execute validation test scripts with objective evidence as per approved procedures
  • Log, track, investigate, and support closure of deviations, defects, and validation observations
  • Validate MES workflows, master data, recipes, electronic batch records, equipment integration, interfaces, and user roles
  • Ensure alignment with GxP, 21 CFR Part 11, EU Annex 11, ALCOA+, data integrity, and internal quality standards
  • Maintain end-to-end traceability from requirements to testing and final validation closure
  • Work closely with MES functional team, technical team, QA, manufacturing SMEs, automation, and business users
  • Ensure validation deliverables are complete, controlled, and inspection-ready
  • Fulltime
Read More
Arrow Right

Senior Consultant/Serialization Specialist

We are looking to strengthen our team in Denmark with a Senior Consultant / Seri...
Location
Location
Denmark , Region Hovedstaden
Salary
Salary:
Not provided
life-science-talent-solutions.dk Logo
Life Science Talent
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 5+ years of experience within IT compliance, serialization, CSV, or similar roles in the Life Sciences industry
  • Hands-on experience with serialization systems (e.g., Level 3/4 solutions, reporting systems, integration layers)
  • Strong knowledge of Computer Systems Validation (CSV) and/or Computer Software Assurance (CSA)
  • Solid understanding of relevant regulations such as: EU GMP Annex 11, FDA 21 CFR Part 11, GAMP5, Serialization regulations (EU FMD, US DSCSA)
  • Experience working with regulated IT systems and compliance frameworks
  • A strong consultancy mindset with excellent communication and stakeholder management skills
  • Ability to translate complex regulatory requirements into practical, business-oriented solutions
  • Experience working across IT, Quality, and Business domains
  • Ability to manage multiple tasks and projects while maintaining high quality
  • A proactive, collaborative, and solution-oriented approach
Job Responsibility
Job Responsibility
  • Acting as SME within Serialization, supporting implementation, rollout, and optimization of serialization solutions
  • Leading and supporting Computer Systems Validation (CSV) activities for serialization and related systems
  • Defining and implementing compliance strategies aligned with global regulatory requirements
  • Supporting IT/QA readiness assessments and developing validation approaches
  • Advising clients on serialization regulations (e.g., EU FMD, US DSCSA) and industry best practices
  • Driving vendor selection, evaluation, and oversight for serialization platforms
  • Supporting integration of serialization systems with ERP, MES, and other enterprise systems
  • Acting as a trusted advisor on compliance, quality, and governance within serialization programs
  • Facilitating workshops with business, IT, and quality stakeholders
  • Supporting audits and inspections related to serialization and validated systems
  • Fulltime
Read More
Arrow Right

Software Development Senior Specialist

We are currently seeking a Software Development Senior Specialist to join our te...
Location
Location
India , Noida
Salary
Salary:
Not provided
nttdata.com Logo
NTT DATA
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Strong hands-on experience with LabVantage LIMS (v7.x / v8.x preferred)
  • In-depth knowledge of laboratory operations (QC, stability, sample management, batch release)
  • Experience with LIMS integrations (ERP, instruments, CDS, MES)
  • Fluent or professional-level German (spoken and written) – mandatory
  • Excellent English and German communication and documentation skills
  • Strong presentation skills with the ability to confidently interact with senior client stakeholders
  • Proven experience in client-facing roles or consulting engagements
  • Ability to manage multiple stakeholders and align business and technical teams
  • Strong analytical, problem-solving, and decision-making skills
Job Responsibility
Job Responsibility
  • Act as the primary client-facing Business Analyst for LabVantage LIMS engagements
  • Lead and facilitate requirements workshops, solution discussions, and stakeholder meetings in German and English
  • Build strong relationships with customer stakeholders across QC, QA, IT, and business teams
  • Clearly articulate solution designs, impacts, and benefits to non-technical audiences
  • Gather, analyze, and document business and functional requirements (URS, FRS, user stories)
  • Translate laboratory processes into LabVantage LIMS functional designs and workflows
  • Perform gap analysis and recommend best-practice solutions aligned with LabVantage capabilities
  • Support LIMS configuration including workflows, master data, and role-based access
  • Ensure all solutions comply with GMP, GxP, and data integrity principles
  • Support Computer System Validation (CSV) activities including URS, FS, IQ/OQ/PQ, and traceability matrices
  • Fulltime
Read More
Arrow Right
New

Social Worker – Fostering - Family and Friends Team

Are you passionate about working with Family and Friends Carers and improving th...
Location
Location
United Kingdom , Aylesbury
Salary
Salary:
40109.00 - 47629.00 GBP / Year
buckinghamshire.gov.uk Logo
Buckinghamshire Council
Expiration Date
July 20, 2026
Flip Icon
Requirements
Requirements
  • Social work qualification
  • Active SWE registration
  • Completed ASYE
  • Working knowledge of legislation and guidance which applies to family and friends work
  • Experience of working in looked after children or with foster carers
  • Knowledge of research, inquiries and recent studies affecting this sector of service and an ability to monitor its application in practice
  • Strong written communication skills
  • Minimum of 2 years post qualifying experience
  • Experience and competence in working with the courts and providing written and verbal evidence
Job Responsibility
Job Responsibility
  • Deliver targeted and specialist social work services in the area of Kinship Care
  • Clarify eligibility and undertake statutory social work assessments
  • Promote the safety and well-being of children and young people
  • Assess and support prospective Family and Friends carers in line with Fostering Regulations and court proceedings
  • Hold a manageable caseload of SG and Reg24 assessments
  • Provide carer support
  • Work within statutory guidelines and fostering regulations
  • Assist with duty with opportunities to deliver training, run support groups and be involved in the organisation of carer events
  • Support the development and growth of the service
What we offer
What we offer
  • Market premium of £2,750 per annum for Grade 7
  • Golden Hello payment after one years service (£1,000 for Grade 6, £2,125 for Grade 7)
  • Competitive salary with a market increment
  • Annual leave up to 30 days per year
  • Opportunity to buy further leave
  • Up to 15 days per year training, learning and development offer
  • Free parking across all office sites
  • Relocation packages available
  • Generous employer pension contribution
  • Discounts on Cafés, restaurants and shops
  • Fulltime
Read More
Arrow Right
New

Spanish Speaking Caregiver

Join Our Team as a Caregiver in Lake Ariel, PA! *Earn Up to $14hr + Extra Cash T...
Location
Location
United States , Lake Ariel
Salary
Salary:
14.00 USD / Hour
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must be willing to work in Lake Ariel
  • Fluent in English, bilingual English/Spanish preferred
  • Availability to work Wednesday, Thursday, Saturday, and Sunday 6am-6pm
  • Reliable transportation required
  • Must be able to travel up to 25 miles to client locations
Job Responsibility
Job Responsibility
  • Bring comfort and companionship to clients in their homes
  • Help with daily care like bathing, dressing, toileting, and meals
  • Keep living spaces clean, safe, and welcoming
  • Offer medication reminders and support healthy routines
  • Communicate concerns and escalate safety issues as needed
  • Be a friendly face and a steady presence
What we offer
What we offer
  • Paid Orientation
  • Weekly Pay
  • Flexible Schedules
  • Earn up to $375 for referring a friend
  • Caregiver Rewards Program
  • Premium Holiday Pay
  • Paid Time Off + Benefits including medical, dental, vision, and retirement
  • Free Employee Assistance Program
  • Discount Perks
  • Career Growth
Read More
Arrow Right
New

Early Years Consultant

Join our Early Years Service, where we champion the joy of learning for the youn...
Location
Location
United Kingdom , Aylesbury
Salary
Salary:
36317.00 - 37780.00 GBP / Year
buckinghamshire.gov.uk Logo
Buckinghamshire Council
Expiration Date
July 02, 2026
Flip Icon
Requirements
Requirements
  • Educated to degree level or minimum three years equivalent experience in a similar managerial role
  • Excellent knowledge and first-hand experience of planning and delivering the EYFS
  • Experience of supporting vulnerable children including those with SEND and working with their families
  • Excellent planning and organisational skills
  • Excellent interpersonal skills
  • Proven ability to negotiate, inspire and maintain highly effective working relationships
  • Skilful communicator with ability to engage and influence customers, partners and stakeholders
Job Responsibility
Job Responsibility
  • Support providers to deliver the EYFS
  • Work with providers to meet the needs of all children including those from vulnerable groups and those with SEND
  • Ensure providers deliver high quality inclusive education
  • Offer advice and support to ensure early years practitioners deliver an inclusive Early Years Foundation Stage curriculum and meet the requirements of the SEND Code of Practice 2014 and Equality Act 2010
  • Provide comprehensive support and advice to providers on safeguarding, child protection and the management of allegations against the workforce, along with sustainability, sufficiency, and finance
  • Contribute to the work of the Early Years Service, ensuring sufficiency of places
  • Support the early years sector and childcare sector with high quality training, facilitating networking groups and providing advice and support to a full range of Early Years and Childcare providers
What we offer
What we offer
  • Fair and inclusive culture
  • Health and well-being initiatives including Employee Assistance Programme, Mental Health First Aiders and mindfulness workshops
  • Unified voice through Employee Representative Group
  • Ongoing support and opportunity to develop and progress in career
  • Opportunities to take part in fun activities such as fundraising and social events
  • Flexible and agile working arrangements
  • Discounts on various cafes, restaurants, shops
  • Auto enrolment onto generous Pension Scheme
  • Opportunity to gain membership to Costco
  • Discounted gym memberships
  • Fulltime
!
Read More
Arrow Right
New

Head of Internal Audit

HSBC is one of the largest banking and financial services organizations in the w...
Location
Location
Israel
Salary
Salary:
Not provided
https://www.hsbc.com Logo
HSBC
Expiration Date
August 31, 2027
Flip Icon
Requirements
Requirements
  • Academic degree (preferable related to finance, accounting or law)
  • 5 years Audit experience
  • 3-5 years experience in the banking industry
  • Role holder must be located in Israel.
  • The role requires flexible and adaptable management style.
  • Fluency in English and Hebrew with strong written and spoken communication skills.
  • Ability to collaborate with colleagues demonstrating proactive approach.
  • Knowledge and experience of risk management and controls in financial services.
  • Knowledge of Internal Audit Frameworks, such as COSO principles and Professional Practice of Internal Auditing, supported by proven experience.
  • Regulatory acquaintance : Bank of Israel
Job Responsibility
Job Responsibility
  • Responsible for the development and implementation of an internal audit strategy in the context of the country and of regulatory requirements, according to regional and global audit policies and methodology.
  • Devise and implement an Annual Audit Plan which, together with the Regional and Global INA coverage, satisfies the needs of regulators and takes account of key risks in the context of the country.
  • Initiating and leading the delivery of audits, based on specific regulatory requirements and/or a critical assessment of the business, and the governance, risk and internal control frameworks.
  • Engaging and collaborating with Global Business, Global Function and Regional Audit Teams and provide strategic advice to them and other internal stakeholders by utilizing knowledge of both the country and the applicable governance, risk and regulatory frameworks.
  • Managing the interface between internal and external stakeholders to ensure a clear understanding of key deliverables.
What we offer
What we offer
  • Tailored professional development opportunities
  • Competitive pay and benefits package
  • Welcoming, diverse and inclusive work environment
  • Industry-leading volunteerism policy
  • Generous matching gift program
  • Comprehensive program of immersive Sustainability and Climate Change Initiatives
  • Employee Resource Groups
  • Fulltime
Read More
Arrow Right
New

Caregiver

Join Our Team as a Caregiver in Berks County! *Earn Up to $13.50hr + Extra Cas...
Location
Location
United States , Reading
Salary
Salary:
13.50 USD / Hour
caregiversamerica.com Logo
CareGivers America
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Must be willing to work in Berks County
  • Must have reliable transportation
  • Must be willing to travel up to 25 miles to client locations
Job Responsibility
Job Responsibility
  • Bring comfort and companionship to clients in their homes
  • Help with daily care like bathing, dressing, toileting, and meals
  • Keep living spaces clean, safe, and welcoming
  • Offer medication reminders and support healthy routines
  • Communicate concerns and escalate safety issues as needed
What we offer
What we offer
  • Paid Orientation
  • Weekly Pay
  • Earn up to $375 for referring a friend
  • Caregiver Rewards Program - Earn extra money for reliability, great care, and MORE
  • Flexible Schedules — Full-time, part-time, and weekend shifts
  • Premium Holiday Pay
  • Paid Time Off + Benefits — Including medical, dental, vision, and retirement
  • Free Employee Assistance Program — Free support for life, mental health, and well-being
  • Discount Perks — Save on entertainment, shopping, etc.
  • Career Growth — build skills and maintain caregiver excellence
Read More
Arrow Right