Position Summary The Associate Director of Validation will lead the Qualification and Validation ... A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering ...
Position Summary The Associate Director of Validation will lead the Qualification and Validation ... A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering ...
... valid US patents. * Support proceedings before the USPTO involving company or third‑party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
... valid US patents. * Support proceedings before the USPTO involving company or third‑party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
Position SummaryThe Associate Director of Validation will lead the Qualification and Validation ... Life Sciences or EngineeringA minimum of 10 years of experience in a biopharmaceutical or related ...
Position SummaryThe Associate Director of Validation will lead the Qualification and Validation ... Life Sciences or EngineeringA minimum of 10 years of experience in a biopharmaceutical or related ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
... QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs, Change Bio-pharma space ... Direct: 732-339-3518 - Ext 2065 Qualifications Bachelor degree in a science or engineering ...
... QA Pharma, Bio, biopharma, cGMP, validation, conformance, CAPAs, Change Bio-pharma space ... Direct: 732-339-3518 - Ext 2065 Qualifications Bachelor degree in a science or engineering ...
They will possess a demonstrated ability to influence positive outcomes and have direct reporting ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...
They will possess a demonstrated ability to influence positive outcomes and have direct reporting ... At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture ...
... valid US patents. * Support proceedings before the USPTO involving company or third-party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
... valid US patents. * Support proceedings before the USPTO involving company or third-party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... Director to lead the dissolution science and biopharmaceutics function for small molecule drug ... Develop, validate, and justify phase-appropriate dissolution methods that link in vitro drug ...
... valid US patents. * Support proceedings before the USPTO involving company or third-party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
... valid US patents. * Support proceedings before the USPTO involving company or third-party ... Ability to work with outside US patent counsel to direct and manage activities before the USPTO.
Validation Engineer
Tucson, AZ · On-site
$39 - $42/hr
We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and ... Our team offers well over 200 years of combined staffing experience providing consulting, direct ...
Quick apply
Validation Engineer
Tucson, AZ · On-site
$39 - $42/hr
We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and ... Our team offers well over 200 years of combined staffing experience providing consulting, direct ...
Equipment Validation Engineer
Vacaville, CA · On-site
$30 - $35/hr
Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom ... direct supervision. Ensure full compliance with current cGMP regulations and Roche/Genentech ...
Quick apply
Equipment Validation Engineer
Vacaville, CA · On-site
$30 - $35/hr
Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom ... direct supervision. Ensure full compliance with current cGMP regulations and Roche/Genentech ...
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant - from process characterization through PPQ and continued process ...
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant - from process characterization through PPQ and continued process ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
Hold teams accountable for cross-functional activities like engineering, validation, and tech ... both direct and indirect reports. Preferred Qualifications: If you have the following ...
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant -- from process characterization through PPQ and continued process ...
Quick apply
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant -- from process characterization through PPQ and continued process ...
Director, MSAT, CMC and Process Validation
San Diego, CA · On-site
$195K - $220K/yr
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant - from process characterization through PPQ and continued process ...
Director, MSAT, CMC and Process Validation
San Diego, CA · On-site
$195K - $220K/yr
As the Director, MSAT & CMC Process Validation, you will lead process validation strategy and ... biopharmaceutical plant - from process characterization through PPQ and continued process ...
QC Validation Specialist
Vacaville, CA · On-site
Under direct supervision, the candidate is responsible for supporting and executing QC laboratory ... Experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of ...
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QC Validation Specialist
Vacaville, CA · On-site
Under direct supervision, the candidate is responsible for supporting and executing QC laboratory ... Experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of ...
The director is responsible for qualification and validation strategy across a highly automated, digitally integrated biopharmaceutical facility, including process equipment, utilities, manufacturing ...
The director is responsible for qualification and validation strategy across a highly automated, digitally integrated biopharmaceutical facility, including process equipment, utilities, manufacturing ...
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Associate Director, Validation
Winston Salem, NC • On-site
ProKidney
• Biotechnology Research and Development • 51 - 200 employees51 - 200 employees
Full-time
Re-posted 2 days ago
Job description
Position Summary
The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA's guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Responsibilities
Qualifications
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
The Associate Director of Validation will lead the Qualification and Validation teams at the site. Serve as a member on project steering, value stream and quality systems performance teams. Establish operational objectives and systems to drive employee engagement and alignment with other departments. Deliver on site objectives while implementing harmonized engineering systems and processes. Provide leadership support to the other sites and validation initiatives as needed. Will lead system validation projects related to authoring and executing validation documentation for laboratory instruments/equipment and systems according to the ISPE GAMP 5 Validation Life Cycle as well as 21CFR Part11 and FDA's guide to Computer Software Assurance. Documentation includes System Validation Plan, User Requirements, Risk Assessment, IQ, OQ, PQ, Test Scripts, Summary reports, Requirements Traceability Matrix (RTM), Periodic Review of Computer Systems, and Data Integrity Assessment.
Responsibilities
- Provide leadership and direction to Validation team members, driving performance and value creation to the site function operational and strategic plans and tasks
- Ensure adequate resourcing (capacity and capability) to accomplish site and OST objectives. Recommend solutions to alleviate constraints
- Regularly interacts with senior management or executives on multi-department projects and challenges. Able to build coalitions for change.
- Continuously improving the culture of the Validation team and the site
- Represents Validation and Emergent during GMP and other regulatory agency inspections (CDC, OSHA, etc.)
- Identify areas to drive down operations costs and improve project delivery efficiency. Develop specific investment strategies to realize these savings
- Hands on troubleshooting and problem solving at the Gemba in support of engineering team members and operations
- Develop and lead small and medium sized continuous improvement projects, remain involved in projects led by staff members
- Direct support to OST head or lead annual OPEX budget for Validation department
- Staff and System Development
- Effective delegation and building confidence and competence within direct reports
- Drive engagement in the technical and personal development of the Validation team and members
- Develops strong relationships with partners (QA, Mfg., etc.) and cultivates these with all team members
- Provide effective and collaborative cross functional leadership to facilitate development of the site strategy and delivery of site objectives
- Champion and enhance the culture of the Validation team
Qualifications
- Bachelor's degree. Preferred Fields of Study: Life Sciences or Engineering
- A minimum of 10 years of experience in a biopharmaceutical or related environment in an engineering or quality related role, with at least 5 years in a leadership role
- Expert knowledge of GxPs, GAMP, CFRs/Annex 11, and Data Integrity requirements for laboratory systems and equipment (Understanding of data integrity principles and security controls including, but not limited to audit trail reviews, user access roles, disaster recovery, business continuity, system implementation, change control, archival, retirement, etc)
- Strong understanding of Validation Lifecycle (GAMP 5) principles
- Experience with calibration and maintenance management software
- Knowledge of electronic document management systems
- Experience with data integrity practices and compliance
- Strong technical writing skills for qualification documents, SOPs, and work instructions
- Ability to manage multiple projects simultaneously with minimal supervision
- Detail-oriented with excellent verbal and written communication abilities
- Ability to adapt to changing priorities in a deadline-oriented environment
- Significant hands-on experience and regulatory expectations knowledge with controls, automation and computer system validation.
- Knowledge of pharmaceutical equipment, such as bioreactors, centrifuges, HVAC systems, building chillers, clean steam generators, and Temperature Controlled Units (e.g. refrigerators, freezers, and incubators) is an advantage.
- Strong knowledge and experience in cGMP, root cause analysis, risk assessment and investigation tools/techniques.
- Experience in writing computer system test scripts, validation protocols and summary reports
ProKidney is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Applicants must be eligible to work in the United States without the need for work visa or residency sponsorship.
About ProKidney
Sourced by ZipRecruiter
Industry
Biotechnology research and development
Company size
51 - 200 Employees
Headquarters location
Winston-Salem, NC, US
Year founded
2019