Senior Validation Engineer – Male and Female

3 weeks ago

Chennai, Tamil Nadu, India Tek Support Full time

Job Title: Senior Validation Engineer Trainer – CSV, CQV & Cleaning

Location: Remote

Position Type: Part-time

Job Summary:

We are seeking an experienced Senior Validation Engineer Trainer with a decade of proven expertise in Cleaning Validation, Computer System Validation (CSV), and CQV (Commissioning, Qualification, and Validation) within the pharmaceutical and medical device industries. The ideal candidate will drive compliance, ensure product and process integrity, and support regulatory submissions in line with global standards (FDA, EMA, MHRA, etc.).

Key Responsibilities:

Cleaning Validation:

  • Develop and execute cleaning validation master plans, protocols (IQ/OQ/PQ), and reports.
  • Perform risk assessments (e.g., MACO calculations, swab and rinse methods).
  • Evaluate equipment and process designs for cleanability.
  • Define and execute cleaning hold time studies.
  • Support cross-functional teams in investigations and CAPAs related to cleaning failures.

CSV (Computer System Validation):

  • Lead the validation lifecycle of GxP systems (ERP, LIMS, MES, SCADA, PLCs, etc.).
  • Prepare validation deliverables: URS, FS, RTM, IQ/OQ/PQ, and validation summary reports.
  • Ensure 21 CFR Part 11 and Annex 11 compliance for electronic records and signatures.
  • Collaborate with IT, QA, and system owners for periodic reviews, revalidation, and audits.
  • Provide guidance during data integrity assessments.

CQV (Commissioning, Qualification, and Validation):

  • Lead end-to-end CQV activities for equipment, utilities (HVAC, PW/WFI), and facilities.
  • Author and execute protocols for FAT, SAT, IQ, OQ, and PQ in alignment with ASTM E2500 or traditional V-model.
  • Support technology transfer, scale-up, and new product introduction projects.
  • Coordinate with Engineering, Manufacturing, and QA during project execution.

Regulatory & Compliance:

  • Ensure compliance with cGMP, GAMP 5, FDA, EMA, WHO, and ISO 13485 standards.
  • Support internal and external audits; provide SME support during regulatory inspections.
  • Maintain comprehensive validation documentation for audit readiness.

Required Qualifications:

  • Bachelor's / Master's degree in Pharmacy, Biotechnology, Engineering, or Life Sciences.
  • Minimum 10 years of relevant experience in CSV, Cleaning Validation, and CQV.
  • Experience in both pharmaceutical and medical device environments.
  • Strong understanding of FDA, EU Annex 15, ICH Q7/Q8/Q9/Q10, and ISO 13485.

Preferred Skills:

  • Excellent documentation, technical writing, and project management skills.
  • Proficient in using validation tools, spreadsheets, and regulatory databases.
  • Cross-functional communication and stakeholder engagement.
  • Experience in automation and data integrity tools is a plus.

Certifications (Preferred but not required):

  • GAMP 5 Certification
  • Lean Six Sigma (Green/Black Belt)
  • PMP or similar project management certification.

  • Senior Validation Engineer – Male and Female

    3 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Senior Validation Engineer Trainer – CSV, CQV & CleaningLocation: RemotePosition Type: Part-timeJob Summary:We are seeking an experienced Senior Validation Engineer Trainer with a decade of proven expertise in Cleaning Validation, Computer System Validation (CSV), and CQV (Commissioning, Qualification, and Validation) within the pharmaceutical...

  • Senior Validation Engineer – Male and Female

    2 days ago

    Chennai, Tamil Nadu, India Tek Support Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Job Title:Senior Validation Engineer – CSV, CQV & CleaningLocation:RemotePosition Type:Part-timeJob Summary:We are seeking an experiencedSenior Validation Engineerwith a decade of proven expertise inCleaning Validation,Computer System Validation (CSV), andCQV (Commissioning, Qualification, and Validation)within thepharmaceutical and medical device...

  • Male Nurse

    22 hours ago

    Chennai, Tamil Nadu, India Antara Senior Care Full time ₹ 12,00,000 - ₹ 18,00,000 per year

    Job Title: Registered Nurse Male (Day/Night Shift)Location: Chennai, OMRCompany: Antara Senior Care (A Max Group Healthcare Company)Job Overview: Antara Senior Care is seeking compassionate, qualified, and experienced nurses to join our team in Chennai. As a Home Healthcare Nurse, you will provide exceptional patient care at the patient's residence, ensuring...

  • Hiring Tamil Voice Process| Freshers| Male&Female| Chennai

    2 days ago

    Chennai, Tamil Nadu, India Freelancer Full time ₹ 1,50,000 - ₹ 1,80,000 per year

    For appointment contact Mithra Domestic Tamil voice processMale and Female freshers onlyChennai locationSalary 15k + incentivesAge limit: 18-28We need immediate joiners

  • Senior packaging trainer/male&female

    2 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Packaging Engineer TrainerLocation: RemoteEmployment type: Part-timeJob Summary:We are seeking an experienced Packaging Engineer Trainer to deliver technical and compliance-focused training programs. The trainer will be responsible for equipping professionals with the knowledge and skills required in packaging design, compliance, validation, and...

  • Senior Packaging Trainer/Male&Female

    2 weeks ago

    Chennai, Tamil Nadu, India Tek Support Full time

    Job Title: Packaging Engineer TrainerLocation: RemoteEmployment type: Part-timeJob Summary:We are seeking an experienced Packaging Engineer Trainer to deliver technical and compliance-focused training programs. The trainer will be responsible for equipping professionals with the knowledge and skills required in packaging design, compliance, validation, and...

  • Anchors (Male & Female) for YouTube Channel

    1 week ago

    Chennai, Tamil Nadu, India Oiidigital Full time ₹ 6,00,000 - ₹ 12,00,000 per year

    Company DescriptionOii.digital is a premier IT Services and Consulting firm dedicated to providing comprehensive solutions for businesses in the digital era. Specializing in cloud computing, cybersecurity, data analytics, software development, and digital transformation, we offer cutting-edge IT services and strategic consulting to help organizations thrive....

  • Senior Clinical Validation Analyst

    2 days ago

    Chennai, Tamil Nadu, India ICON plc Full time ₹ 12,00,000 - ₹ 36,00,000 per year

    Senior CVA, Chennai, Office basedICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical Validation Analyst to...

  • Junior Validation Engineer

    2 days ago

    Chennai, Tamil Nadu, India ValGenesis Full time ₹ 2,50,000 - ₹ 7,50,000 per year

    About ValGenesis ValGenesis is a leading digital validation platform provider for life sciences companies. ValGenesis suite of products are used by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance and manufacturing excellence/intelligence across their product lifecycle Learn more about working...

  • Validation Test Engineer

    2 days ago

    Chennai, Tamil Nadu, India Capegemini Full time ₹ 20,00,000 - ₹ 25,00,000 per year

    Role : Validation Test Eng Position-PlatformJob Description :Bachelors degree in computer science/Electronics/Electrical Engineering, or related field. Requires 4 12 years of progressive engineering experience in SW testing in embedded projects. Hands-on experience in board bring up & diagnostic. Working knowledge in BMC/iDRAC/iLO with GUI/Redfish/IPMI...