Project Manager
La Verne, CA · On-site
... GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also ... Maintain overall project and issue tracker and report routinely. * Support release management ...
Project Manager
La Verne, CA · On-site
... GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also ... Maintain overall project and issue tracker and report routinely. * Support release management ...
Project Manager
Santa Clara, CA · On-site
Project Manager Job Locations US-CA-Santa Clara Requisition ID 2026-13195 Category Project ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Project Manager
Santa Clara, CA · On-site
Project Manager Job Locations US-CA-Santa Clara Requisition ID 2026-13195 Category Project ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Sr. Engineering Project Manager
Vista, CA · On-site
$126K - $173K/yr
Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc ... Act as the lead project manager for the design and construction of new plant expansions and plat ...
Sr. Engineering Project Manager
Vista, CA · On-site
$126K - $173K/yr
Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc ... Act as the lead project manager for the design and construction of new plant expansions and plat ...
Sr. Engineering Project Manager
Vista, CA · On-site
$126K - $173K/yr
Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc ... Act as the lead project manager for the design and construction of new plant expansions and plat ...
Sr. Engineering Project Manager
Vista, CA · On-site
$126K - $173K/yr
Oversee CapEx projects for new GMP laboratories and equipment (AHU, dehumidifiers, chillers, etc ... Act as the lead project manager for the design and construction of new plant expansions and plat ...
Project Manager
Los Angeles, CA · On-site
$120K - $160K/yr
Work closely with the Estimator during the preconstruction phase in managing the various design phases and setting the GMP and establishing the projects General Conditions * Work closely with the ...
Project Manager
Los Angeles, CA · On-site
$120K - $160K/yr
Work closely with the Estimator during the preconstruction phase in managing the various design phases and setting the GMP and establishing the projects General Conditions * Work closely with the ...
Project Manager
Irvine, CA · On-site
$115K - $165K/yr
Work closely with the Estimator during the preconstruction phase in managing the various design phases and setting the GMP and establishing the projects General Conditions * Work closely with the ...
Project Manager
Irvine, CA · On-site
$115K - $165K/yr
Work closely with the Estimator during the preconstruction phase in managing the various design phases and setting the GMP and establishing the projects General Conditions * Work closely with the ...
Familiarity with GMP-regulated environments or willingness to learn. * Experience with CAD systems (AutoCAD, Revit) or project management software (Procore, Bluebeam, MS Project). * Understanding of ...
Familiarity with GMP-regulated environments or willingness to learn. * Experience with CAD systems (AutoCAD, Revit) or project management software (Procore, Bluebeam, MS Project). * Understanding of ...
CA · On-site
$90/hr
The Project Manager I will develop, plan, direct and control projects associated with drug product ... Strong knowledge of GMP's, CFR's, ICH, and ISO Regulations and familiarity with OSHA, EPA, and ...
Quick apply
CA · On-site
$90/hr
The Project Manager I will develop, plan, direct and control projects associated with drug product ... Strong knowledge of GMP's, CFR's, ICH, and ISO Regulations and familiarity with OSHA, EPA, and ...
Project Manager I *PC 1345
San Jose, CA · On-site
$95K - $112K/yr
The Project Manager I is responsible for managing internal and client-sponsored cell and gene ... Ensure compliance with applicable GMP, regulatory, quality, and company requirements while ...
Project Manager I *PC 1345
San Jose, CA · On-site
$95K - $112K/yr
The Project Manager I is responsible for managing internal and client-sponsored cell and gene ... Ensure compliance with applicable GMP, regulatory, quality, and company requirements while ...
Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11. * Experience managing Computer System Validation (CSV) projects. * Experience delivering projects involving MES, LIMS ...
Strong understanding of GMP, GxP, GAMP 5, FDA regulations, and 21 CFR Part 11. * Experience managing Computer System Validation (CSV) projects. * Experience delivering projects involving MES, LIMS ...
Project Manager in San Diego
San Diego, CA · On-site
$150 - $200/hr
Director of Project Management STATUS: Full Time LOCATION: Varies Between Remote and at multiple ... Applies knowledge and experience of facility programming, space planning, GMP material/personnel ...
New
Project Manager in San Diego
San Diego, CA · On-site
$150 - $200/hr
Director of Project Management STATUS: Full Time LOCATION: Varies Between Remote and at multiple ... Applies knowledge and experience of facility programming, space planning, GMP material/personnel ...
New
Project Manager I *PC 1345
San Jose, CA · On-site
$95K - $112K/yr
The Project Manager I is responsible for managing internal and client-sponsored cell and gene ... Ensure compliance with applicable GMP, regulatory, quality, and company requirements while ...
Project Manager I *PC 1345
San Jose, CA · On-site
$95K - $112K/yr
The Project Manager I is responsible for managing internal and client-sponsored cell and gene ... Ensure compliance with applicable GMP, regulatory, quality, and company requirements while ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Santa Clara, CA · On-site
Gains an understanding of the estimating process from conceptual phase through GMP development. * Identifies, understands and actively manages project risks. * Understands and manages project ...
Project Manager
Irvine, CA · On-site
$120 - $165/hr
The Project Manager will handle the following responsibilities Project Management: * Completes full ... Displays adept and very knowledgeable estimates, value engineering, guaranteed maximum price (GMP ...
New
Project Manager
Irvine, CA · On-site
$120 - $165/hr
The Project Manager will handle the following responsibilities Project Management: * Completes full ... Displays adept and very knowledgeable estimates, value engineering, guaranteed maximum price (GMP ...
New
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
MES Project Manager
Sunnyvale, CA · On-site
MES Project Manager (REMOTE-USA) The Select Group is undertaking a large-scale Manufacturing ... Familiarity with validation processes in regulated manufacturing (GMP/FDA) * Prior experience with ...
MES Project Manager
Sunnyvale, CA · On-site
MES Project Manager (REMOTE-USA) The Select Group is undertaking a large-scale Manufacturing ... Familiarity with validation processes in regulated manufacturing (GMP/FDA) * Prior experience with ...
Project Manager
Santa Clara, CA · On-site
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Project Manager
Santa Clara, CA · On-site
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Project Manager
Santa Clara, CA · On-site
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
Project Manager
Santa Clara, CA · On-site
Gilbane is seeking a Project Manager to be responsible for supporting the Senior Project Manager ... GMP * Prepares monthly schedule updates, including schedule analysis, and narratives for select ...
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Full-time
Re-posted 17 days ago
Job description
Should know GxP, Validation and possibly MES
GxP Documentation is must
Seeking a Project Manager with experience in Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing a must (Okay with either industry)
Responsibility:
- This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.
- Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system.
- Perform GxP and 21 CFR part 11 assessments and develop validation plan.
- Develop functional risk strategy and perform functional risk assessment.
- Review user business process documents and user requirements specification.
- Review functional, technical and configuration design documents.
- Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
- Review the test scripts for the requirements and test scenario coverage.
- Lead overall protocol executions, log and track defects.
- Review the executed test reports for the proper documentation of test results and evidence.
- Review the defects for proper documentation per the checklist.
- Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
- Prepare and approve qualification summary report.
- Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
- Maintain overall project and issue tracker and report routinely.
- Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
- Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
- Maintain day to day activities status tracker and report routinely.
- Lead the team of validation engineers located in different time zones.
Skills:
- Excellent communication (oral and written) and attention to detail.
- 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects.
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11.
- Excellent knowledge of computer system validation and GAMP -5 standards.