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Quality Validation Engineer III

In California / United States

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Quality Validation Engineer III   

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JOB TITLE:

Quality Validation Engineer III

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Carlsbad California / United States

JOB DESCRIPTION:

Description

Pay Rate: XXX

Quality Assurance, Cleaning Validation Engineer III

Requisition ID: NEED

When you join us at Client Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of XXX billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The role is responsible for Cleaning Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

How will you make an impact?

The Cleaning Validation Engineer will be responsible for the execution of cleaning validation activities to support enzyme manufacturing, generating and executing cycle development, cleaning verification and cleaning validation documentation including protocols, final reports, deviations and SOPs while ensuring compliance to GMP requirements.

What will you do?

  • Develop and execute cleaning validation protocols to support all required cleaning validation efforts, this will include but not limited to: Clean Hold and Dirty Hold cleaning validation activities.
  • Coordinate, schedule and execute all cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
  • Investigate and troubleshoot problems which occur during cleaning processes.
  • Lead investigations for deviations encountered during the execution of Cleaning Validation and/or continuous monitoring/verification activities and provide documentation to support the findings.
  • Develops and authors change controls for cleaning process or equipment changes.
  • Write validation plans and risk assessments related to specific projects and facilities.
  • Perform risk assessment and gap analysis for site cleaning programs.
  • Coordinate and provide training and/or opportunities for career development of others.
  • Perform other duties as assigned.
  • Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.

How will you get here?

Education

  • Bachelor s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

  • Minimum of 3-5 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of two (2) years direct cleaning validation experience.
  • Solid understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
  • Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.

Knowledge, Skills, Abilities (Required)

  • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in Biotech and/or Pharmaceutical industry
  • Excellent communication and listening skills
  • Ability to build and maintain strong collaborative relationships across multiple departments
  • Microsoft Office and database management skills
  • Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Knowledge, Skills, Abilities (Preferred)

  • Experience with biological manufacturing processes.
  • Project Management advanced experience.
  • Certified Lean Professional or Six Sigma Black Belt
Skill/Experience/Education
QA, Cleaning Validation Engineer III
Contingent Hourly (CWHR)-TEM.CWHR.A00
Special Needs

Position Details

POSTED:

Jul 05, 2021

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864959443504

LOCATION:

California / United States

CITY:

Carlsbad

Job Origin:

CEIPAL_ORGANIC_FEED

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In Dallas Fort Worth
Aug 19, 2017 9am-6pm
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Quality Validation Engineer III    Apply

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Description

Pay Rate: XXX

Quality Assurance, Cleaning Validation Engineer III

Requisition ID: NEED

When you join us at Client Scientific, you ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of XXX billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Location/Division Specific Information

The role is responsible for Cleaning Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID), part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets: Academia, Research, Biotech, Pharma, Cell and Gene Therapy and Medical Devices.

How will you make an impact?

The Cleaning Validation Engineer will be responsible for the execution of cleaning validation activities to support enzyme manufacturing, generating and executing cycle development, cleaning verification and cleaning validation documentation including protocols, final reports, deviations and SOPs while ensuring compliance to GMP requirements.

What will you do?

  • Develop and execute cleaning validation protocols to support all required cleaning validation efforts, this will include but not limited to: Clean Hold and Dirty Hold cleaning validation activities.
  • Coordinate, schedule and execute all cleaning development, validation and, continuous monitoring/verification activities with appropriate departments.
  • Investigate and troubleshoot problems which occur during cleaning processes.
  • Lead investigations for deviations encountered during the execution of Cleaning Validation and/or continuous monitoring/verification activities and provide documentation to support the findings.
  • Develops and authors change controls for cleaning process or equipment changes.
  • Write validation plans and risk assessments related to specific projects and facilities.
  • Perform risk assessment and gap analysis for site cleaning programs.
  • Coordinate and provide training and/or opportunities for career development of others.
  • Perform other duties as assigned.
  • Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences.

How will you get here?

Education

  • Bachelor s degree from an accredited college/university with a preference for Science, Engineering, Biochemistry, Biotechnology, Biology or Biomedical Engineering.

Experience

  • Minimum of 3-5 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Must have a minimum of two (2) years direct cleaning validation experience.
  • Solid understanding of GMP guidance, including 21 CFR Part 11, and Annex 11.
  • Prefer hands-on industry experience in cGMP/Biotech/Biopharmaceutical/FDA regulated industries.
  • Experience with and knowledge of related quality systems such as Change Control; CAPA (including: Deviations/OOSs); Training; and Document Control is required.

Knowledge, Skills, Abilities (Required)

  • Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annex 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems in Biotech and/or Pharmaceutical industry
  • Excellent communication and listening skills
  • Ability to build and maintain strong collaborative relationships across multiple departments
  • Microsoft Office and database management skills
  • Position requires knowledge of Current Good Manufacturing Practices (cGMPs) and FDA/industry regulations.

Knowledge, Skills, Abilities (Preferred)

  • Experience with biological manufacturing processes.
  • Project Management advanced experience.
  • Certified Lean Professional or Six Sigma Black Belt
Skill/Experience/Education
QA, Cleaning Validation Engineer III
Contingent Hourly (CWHR)-TEM.CWHR.A00
Special Needs


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