Pharma Project Manager (100% onsite ) – Looking for candidates preferably from Cali or nearby State
Location: La Verne, CA - Sample resume is attached
Client: Pharma
Duration: 12 months
Rate: $85hr W2 or $95hr c2c/1099
Should know GxP, Validation and possibly MES
GxP Documentation is must
Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must ( Okay with either industry )
Overall 20 years required
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.
Let me know if you can work on this revised position
There have been significant changes to this position since they are having such a hard time trying to fill it. Most importantly they have drastically increased the salary range ($150-170H)
if the person has their PE and specifically has experience designing HVAC and plumbing on commercial buildings along with meeting the bullets below. If someone doesn’t have their PE yet the salary is considerably lower until they get their PE.
This is similar to the old one, but they have drastically changed the pay range. They specifically want someone with the following
HVAC and plumbing design work on commercial builders with a design or engineering company
Have their PE or be able to get it in a year
Be located in Charlotte NC or Grand Rapids MI area
Have excellent communication skills
Have a steady job history and not jumping every 2 years
Must have an Engineering degree
Functional Job Title: Senior Mechanical Engineer – Direct Hire - Sample resume is attached
Location (City State, Street Name): Charlotte NC
Salary and/or Hourly Pay Rate:
Direct Hire Salary: $100,000 - $150,000
Client: Progressive Companies
The mechanical engineer positions – there are now 3 openings.
They need experience working for architectural and design firms on commercial and healthcare buildings doing HVAC and plumbing work to be very specific.
They will look at out of market candidates. They do not pay relo but can pay upto $7500 sign on bonus to help with moving costs
Specifics on this position
The person can be in the Charlotte NC or Grand Rapids Michigan office
Hybrid – Tues, Wed, and Thurs in office – Mon/Fri from home
They must have experience in Mechanical Engineering with some sort of healthcare or hospital buildings
Strong experience with HVAC and plumbing design
Salary can vary greatly based on years of experience
Company benefits are a huge selling point as they are great benefits, and they also offer profit sharing, bonuses and high 401K
This is a Direct hire position with a salary range of $100,000 - $150,000 based on years of experience of with excellent benefits, profit sharing and bonus located in Charlotte NC
Position Description
Senior Mechanical Engineer
Fast growing Architecture company is seeking a Senior Engineer. As a Senior Healthcare Mechanical Engineer, you will take a leadership role in building the Healthcare practice together with leadership; designing and developing mechanical systems holistically and conceptually; generating and translating mechanical systems into final solutions for various healthcare and research building types as part of a dynamic multi-disciplinary project team. You will have the opportunity to influence a projects direction and outcomes by taking a proactive role in the design and development of documentation and supervising a projects implementation in the field.
Deliver Results
Provide extensive expertise in the technical aspects of the mechanical design including code compliance, specifications, system integration and constructability
Work cross functionally to create project scope and budget, provide quality assurance, conduct work sessions and meetings, troubleshoot issues, prepare project documentations, and to coordinate other technical project components.
Attend site-visits to resolve issues encountered in the field such as unforeseen conditions, code issues, and interpretation of construction documents.
Coordinate the work of the mechanical design team through the schematic design development and construction document phase of a project. Review completed reports, submittals, drawings, estimates and calculations for accuracy.
Prepare building models, detailed contract documents, construction documents, photometric simulations, arc flash and specifications consistent with Progressive AE’s standards. Determine and promote the best use of design software and technology to accomplish these tasks most efficiently.
Ensure the overall design intent of the project established by the Performance Based Design process is incorporated into the detailed documentation.
Bachelor’s degree in mechanical engineering from an EAC/ABET-accredited program or equivalent in education and experience required for professional licensure.
Licensed Professional Engineer (PE) with current license OR ability to obtain PE.
8 - 10+ years of relevant experience with a wide variety of project types.
Must have experience in the healthcare industry and good HVAC systems experience
Strong knowledge of Revit and/or AutoCAD.
Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
Preferred Qualifications
Multiple state licensures.
CSI-CDT certification.
LEED AP BD+C and WELL AP certification.
Membership at organizations such as American Society for Health Care Engineering (ASHE), Healthcare Engineering Alliance Society (HEALS), or similar and their local chapters.
NCEES registration and NSPE membership.
Track of reporting and/or presenting at professional organizations conferences, publishing white-papers and demonstrating internal and external thought leadership
Key Words:
Engineering
Mechanical
Mechanical Engineer
LPE
Licensed professional Engineer
AutoCAD
Revit
Commercial buildings
Government
Bachelor’s Degree Requirement: Yes
Role | 2 roles: Senior Technical Lead (Around $60/hr c2c) Information Security Specialist (Around $55/hr c2c) |
Job ID | RFO 24-0169260 |
Client Name | California Department of Technology |
Location | Remote |
Duration | 1 year + 2 (1) year terms |
Rate | As above - Okay with H1's |
Degree Copy | Yes |
References | 3 ( okay with one reference but it has to be from State of Cali ) |
Experience with the state of California and other state/federal agencies is mandatory.
Project Summary
The California Department of Technology (CDT) seeks experienced security consultants to enhance its Vulnerability Management Improvement Program (VMIP). The project aims to strengthen cybersecurity by deploying scalable security solutions, including Insider Threat detection, Web Application scanning, and System Security Plan management. Consultants will be responsible for designing, implementing, and maintaining security protocols to mitigate vulnerabilities and ensure compliance with FedRAMP and NIST 800-53 standards. The initiative supports the state's IT security strategy through risk assessment, continuous monitoring, and technical expertise.
Senior Technical Lead
Minimum Qualifications:
Minimum of 5 years of experience executing projects for the State of California.
Minimum of 3 years of knowledge and experience using FedRAMP compliance.
Minimum of 3 years of experience working with State Administrative Manual (SAM) 5300 and Statewide Information Management Manual (SIMM) standards.
Minimum of 5 years of experience applying security policies, standards, testing, modification, and implementation.
Minimum of 3 years of experience in identifying gaps between current and target architecture and developing transition plans for Information Security.
Minimum of 3 years of experience in defining policies and principles for enterprise architecture and identifying improvements in enterprise systems.
Minimum of 3 years of experience documenting enterprise architecture infrastructure, including key business processes using modeling techniques.
Minimum of 3 years of experience in the NIST 800-53 Framework.
Minimum of 2 years of public sector experience (Federal and/or State).
Desirable Qualifications:
Master’s degree from an accredited university.
Cloud certification (Microsoft Azure or Amazon Web Services - AWS).
Job Responsibilities:
Planning, designing, and building the Vulnerability Management Improvement Program (VMIP) environments.
Developing and documenting enhancements for the VMIP.
Performing functional, system, and integration testing while supporting customer testing.
Leading development teams, providing guidance, and ensuring smooth execution of security projects.
Deploying new security changes to production and verifying operational integrity; rolling back changes when necessary.
Providing Maintenance & Operations (M&O) support for VMIP.
Troubleshooting technical issues, performing root cause analysis, and implementing corrective actions.
Ensuring compliance with State of California IT policies, FedRAMP, and NIST 800-53 standards.
Working closely with the Departmental Information Security Office (DISO) to implement secure solutions.
Documenting and reporting project progress through weekly status reports.
Conducting knowledge transfer and mentoring CDT personnel on best practices.
Information Security Specialist
Minimum Qualifications:
Minimum of 5 years of experience executing projects for the State of California.
Minimum of 3 years of knowledge and experience using FedRAMP compliance.
Minimum of 3 years of experience working with State Administrative Manual (SAM) 5300 and Statewide Information Management Manual (SIMM) standards.
Minimum of 5 years of experience applying security policies, standards, testing, modification, and implementation.
Minimum of 3 years of experience in the NIST 800-53 Framework.
Minimum of 2 years of public sector experience (Federal and/or State).
Desirable Qualifications:
Certified Information Systems Security Professional (CISSP).
Certified Ethical Hacker (CEH).
Minimum of 10 years of experience in Cybersecurity.
Job Responsibilities:
Assisting in the design, implementation, and enhancement of security measures within the Vulnerability Management Improvement Program (VMIP).
Conducting risk assessments and security analysis to identify vulnerabilities.
Implementing Insider Threat solutions, Web Application scanning, and managing POAM (Plan of Action & Milestones) and System Security Plans (SSP).
Applying and ensuring adherence to security policies, standards, and frameworks such as FedRAMP and NIST 800-53.
Performing vulnerability scanning, penetration testing, and security audits.
Assisting in the development of security reports and providing recommendations for mitigation strategies.
Coordinating with CDT staff and external security teams to address vulnerabilities.
Maintaining compliance documentation and ensuring all security procedures meet California State IT regulations.
Preparing and participating in security incident response and remediation activities.
Contributing to security awareness training and knowledge transfer to CDT personnel.
Role | Programmer |
Job ID | ITCS 2408 |
Client Name | California Department of Insurance |
Location | Remote |
Duration | Around 6 months - Okay with H1 |
Rate | Market Rate |
Degree Copy | Yes |
References | 3 |
- Experience with the state of California and other state/federal agencies is desired.
Project Summary
The California Department of Insurance (CDI) seeks a Resource/Programmer to provide technical support, maintenance, and development for Application Express (APEX) applications and licensing systems. The contractor will work with Oracle Databases, Weblogic, and Java to develop new applications, integrate third-party APIs, and support existing licensing platforms. The role includes system development, troubleshooting, and knowledge transfer to CDI staff while ensuring seamless functionality and security of regulatory systems.
Minimum Qualifications:
- At least 5 years of experience, within the last 10 years, in utilizing the Oracle development tool set including Java Programming, Oracle JDeveloper, Oracle Forms & Reports, Oracle Weblogic Server – OAS 12c, Oracle database versions 11g, 12c, and 19c, SQL, and PL/SQL.
- At least 5 years of experience, within the last 10 years, in developing and maintaining APEX and JAVA applications.
- Develop and maintain interactive Java and APEX web applications
- Develop and maintain Java batch applications and supporting shell scripts
- Develop and maintain SOAP and RESTful web services written in Java, APEX, and PL/SQL
- Processing of JSON formatted data utilizing Java and APEX JSON APIs
- Creating Oracle Bi Publisher reports
- At least 3 years of experience, within the last 5 years, in supporting and maintaining hardware and software infrastructures.
- Provide maintenance and support on Linux VM servers
- Provide maintenance and support on Oracle Application Server, Weblogic 11g and 12c
- Providing Oracle Database Administration
- At least 5 years of experience, within the last 10 years, maintaining Sircon powered by Vertafore insurance industry regulatory licensing software.
- At least 5 years of experience, within the last 10 years, integrating internal software applications with external vendor APIs., including designing, developing, implementing and testing Multi-Tier Applications.
- At least 3 years of experience, within the last 10 years, with knowledge transfer to technical staff.
- At least 3 years of experience, within the last 10 years, creating and maintaining web services which integrate with COTS workflow applications.
- At least 3 years of experience, within the last 10 years, writing and maintaining shell scripts on either Unix or Linux operating systems.
- At least 5 years of experience, within the last 10 years, providing support and maintenance for interfaces with third-party payment gateway systems such as Elavon.
- At least 5 years of experience, within the last 10 years, with the SDLC, project schedules, work plans, business analysis and documentation, troubleshooting and fixing software defects.
Job Responsibilities:
- Develop and maintain APEX applications and Java-based solutions
- Design and implement RESTful APIs and web services
- Support and maintain Oracle Forms & Reports 12c applications
- Integrate internal software with third-party payment gateways (e.g., Elavon)
- Troubleshoot and resolve software defects
- Perform Oracle Database Administration (11g – 19c)
- Develop and maintain PL/SQL scripts and procedures
- Optimize database performance and security
- Assist in server upgrades and maintenance patches
- Support Weblogic Administrators in application deployments and version upgrades
- Conduct testing for HTTPS/TSL 1.3 upgrades and security patches
- Follow Software Development Life Cycle (SDLC) processes
- Work closely with CDI Project Manager to identify risks and resolve issues
- Prepare and maintain technical documentation and reports
- Provide training and mentoring to CDI staff
- Ensure proper documentation of applications and troubleshooting processes
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