Open Roles - 2/28/2025 - Recruitment House

Position: Sr. Validation Engineer (CSV) with decommissioning experience – 100% Onsite – Sample resume is attached

Location: La Verne, CA

Client: Pharma

Duration: 12 months

Rate: $65hr W2 or $73hr c2c/1099

H1's accepted

Looking for profiles having around 10-12 years of overall experience

Responsibilities:

Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)

Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans

Providing leadership, oversight, and training related to validation activities to multi-functional teams

Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP)

Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements

Working with appropriate teams to establish quality expectations related to validation planning and execution

Participating with stakeholders in the preparation of software specification documents, risk management and validation plans

Participating in developing qualification processes and implementing standard operating procedures

Participate in execution of gap assessment and remediation activities

Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols

Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities

Preparing for and participating in external/internal computer system/software audits

Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise

Contributing to process improvements by developing and updating written procedures related to computer systems

Skill competencies

At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry

Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques

Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality

Demonstrated project management and leadership skills

Proficiency in interacting with contacts, including project teams and vendors

Certified auditor or equivalent experience conducting software-vendor quality audits

Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives

Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP

Experience with the following software systems/applications:

Quality Management System

Document Management System

Validation Management System

Bachelor’s/master’s degree in computer science engineering or equivalent

Pharma Project Manager (100% onsite ) – HOT HOT HOT – Sample resume is attached

Location: La Verne, CA

Client: Pharma

Duration: 12 months

Rate: $85hr W2 or $95hr c2c/1099

Ok with H1

If you can find one preferably from Cali then I can get them an interview asap, two who got interviewed were from outside of Cali but none clicked

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.

Senior Mechanical Engineer – Direct Hire – Sample resume is attached

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

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
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 3 months
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.