Open Roles - 3/4/2025 - 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

Job Title: Regulatory Pharma Project Management (RPM)

Location: Foster City, Cali – Hybrid ( Fully remote for ROCKSTAR – I can make it work that way)

$70hr W2 or $78hr c2c

12 months

Ok with H1

Around 12 years overall experience required

Should be from Pharma/Lifescience Industry

POSITION OVERVIEW:

With increasing independence, you will support other Development team members with project and/or process administrative tasks of low complexity. Your responsibilities include, but are not limited to, supporting project communications, conducting follow-up with project team members, partners or stakeholders, tracking project information, helping maintain project timelines, and performing other administrative work to support RPM colleagues and project team members. With close supervision and guidance, you may also manage sub-projects.

RESPONSIBILITIES:

Manages basic department/cross-functional specific programs and/or initiatives.
Manages basic project/initiative communications and works in partnership with senior-level Project Management to ensure that all stakeholders are fully informed and knowledgeable of project activities and their status.
Provides Regulatory Project Management support for assigned programs/projects/initiatives; may attend sub-team meetings.
Fosters effective and productive communication among various Regulatory Affairs groups including Regional Regulatory Leads, Regulatory CMC, Labeling, Advertising and Promotion, Regulatory Operations, Medical Writing, and representatives from other functional areas, as appropriate.
Identifies and manages critical path activities.
Supports 1 – 2 Regulatory Projects, including but not limited to cross-reference INDs, original INDs, and simpler RTQs.
In relation to regulatory submissions, tracks and prepares project information and activities, including minutes, timelines, action items and function-specific deliverables. Ensures integration of project timing, scope and resources.
Works in partnership with senior-level Project Management and/or Project Lead to ensure timely, efficient and effective meetings and progress on activities between meetings.
Works in partnership with senior Project Manager and/or Project Lead to execute on deliverables.
May coordinates basic team operations and communications.
Works with senior Project Management to generate periodic project team and sub-team updates and assists with preparation of formal presentations as required.
May implement routine process improvement and optimization initiatives as required.
May manage sub-projects as assigned.
Focuses on operational tasks, learns how to manage submissions independently, and starts to develop a strategic mindset.
Ensures project work complies with established practices, policies and processes and any regulatory or other requirements.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

BA/ BS with 5+ years’ relevant project management or scientific experience in the biopharma industry, or 3+ years’ relevant experience with an advanced degree.
A scientific background is preferred.
Relevant experience consists of work in a scientific field or equivalent experience with R&D project teams and/or cross-functional project management activities.
PMP (Project Management Professional) or other PM certification or equivalent is a plus.

Knowledge & Other Requirements

Knowledge of the drug development process.
Modest knowledge of regulatory requirements specific to key regions such as the US and EU, and have a general awareness of current global and regional trends in Regulatory Affairs.
Experience in assisting with multiple projects and flexibly adapting to changing priorities.
Experience in assisting with project scope, timelines and deliverables.
Awareness of Agile Methodologies and their application in the R&D biopharma environment.
Organizational awareness and knowledge of change management with the ability to support senior Project Management in an evolving environment.
Ability to communicate in a clear and concise manner.
Ability to support team-oriented, highly-matrixed environment.
Ability to execute multiple tasks as assigned.
Must be quality driven individual with strong attention to detail and accuracy.
Ability to support an inclusive environment of empowered teams who operate with high standards of alignment, trust, accountability, expertise, transparency, and collaboration.
Knowledge and skill with Microsoft Project, Microsoft Excel and other reporting and tracking tools.

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	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.