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Validation Engineer

In California / United States

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Validation Engineer   

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JOB TITLE:

Validation Engineer

JOB TYPE:

JOB SKILLS:

JOB LOCATION:

Carlsbad California / United States

JOB DESCRIPTION:

DescriptionPay Rate: XXX Quality Assurance, Equipment Validation Engineer 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 Equipment 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? We are looking for a self-driven, reliable and resourceful Equipment Validation Engineer to develop and support the successful implementation of manufacturing laboratory equipment. What will you do? Supports execution of equipment validation protocols and associated reports (IQ, OQ, PQ) while adhering to the site Change Management process. Supports writing procedures for equipment calibration and preventive maintenance of equipment, where applicable. Supervises vendors for qualification functions, where necessary. Support manufacturing laboratory equipment implementation including but not limited to IOPQs, user requirement specifications, traceability matrices, etc. Maintains all qualified and validated equipment in compliance with policies, guidelines and procedures. Provides technical support and guidance on equipment qualification issues Manage projects of varying scope and complexity. Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences. Provide knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks. 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 2-4 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Knowledge, Skills, Abilities (Required) Excellent communication, collaboration and interpersonal skills with the ability to partner with and influence key stakeholders including Manufacturing, Technical Operations, Equipment Services, etc. Strong capability to leverage work with diverse teams, facilitate agreement, build collaborative relationships and focus on customer needs. Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts. Compliance with regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, ISO 9001, ISO 13485, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations). Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis Global Systems e.g. TrackWise, AGILE, E1, LIMS Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.). Knowledge, Skills, Abilities (Preferred) Experience with biological manufacturing processes. Project Management advanced experience. Certified Lean Professional or Six Sigma training Skill/Experience/EducationQA, Equipment Validation EngineerContingent Hourly (CWHR)-TEM.CWHR.A00Special Needs

Position Details

POSTED:

Apr 02, 2022

EMPLOYMENT:

INDUSTRY:

SNAPRECRUIT ID:

S16204864965783513

LOCATION:

California / United States

CITY:

Carlsbad

Job Origin:

CEIPAL_ORGANIC_FEED

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DescriptionPay Rate: XXX Quality Assurance, Equipment Validation Engineer 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 Equipment 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? We are looking for a self-driven, reliable and resourceful Equipment Validation Engineer to develop and support the successful implementation of manufacturing laboratory equipment. What will you do? Supports execution of equipment validation protocols and associated reports (IQ, OQ, PQ) while adhering to the site Change Management process. Supports writing procedures for equipment calibration and preventive maintenance of equipment, where applicable. Supervises vendors for qualification functions, where necessary. Support manufacturing laboratory equipment implementation including but not limited to IOPQs, user requirement specifications, traceability matrices, etc. Maintains all qualified and validated equipment in compliance with policies, guidelines and procedures. Provides technical support and guidance on equipment qualification issues Manage projects of varying scope and complexity. Drive a culture of continuous improvement by employing Practical Process Improvement concepts and reporting metrics and communicating internally to diverse audiences. Provide knowledge and insight into qualification and validation activities and the ability to work effectively with engineering and operations teams in completing these tasks. 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 2-4 years experience within the Medical Device or Pharmaceutical Industry supporting Regulated Products. Knowledge, Skills, Abilities (Required) Excellent communication, collaboration and interpersonal skills with the ability to partner with and influence key stakeholders including Manufacturing, Technical Operations, Equipment Services, etc. Strong capability to leverage work with diverse teams, facilitate agreement, build collaborative relationships and focus on customer needs. Practical application experience in continuous improvement methodologies to improve processes, strengthen quality and drive efficiency. Strong analytical ability including the ability to effectively use data in problem solving and to evaluate process changes and impacts. Compliance with regulated quality management system standards (e.g., 21 CFR Part 820, 21 CFR part 210/211, ISO 9001, ISO 13485, MDSAP, ICH Q7, Eudralex volume 4 requirements and excipient manufacturing regulations). Quality tools e.g. FMEA, Risk Analysis, Root Cause Analysis Global Systems e.g. TrackWise, AGILE, E1, LIMS Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.). Knowledge, Skills, Abilities (Preferred) Experience with biological manufacturing processes. Project Management advanced experience. Certified Lean Professional or Six Sigma training Skill/Experience/EducationQA, Equipment Validation EngineerContingent Hourly (CWHR)-TEM.CWHR.A00Special Needs


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