Engineering Jobs in Balboa, CA

Department

Research & Development (R&D)

Summary

nRichDX is seeking an R&D team member whose primary responsibility will be quality control and functional testing of nucleic-acid extraction kits (cfDNA/cfRNA/cfTNA/CTC-related), supporting product releases and manufacturing scale. This role will also contribute to routine R&D workflows, including method verification, troubleshooting, documentation, and data generation for continuous improvement and external deliverables.

Key Responsibilities

Kit QC & Functional Testing (Primary)

• Own and execute functional testing plans for commercial kit lots (incoming components, in-process, and final kit performance testing).
• Run routine QC assays, including (as applicable):
• qPCR/RT-qPCR (recovery, inhibition checks, linearity)
• TapeStation/Bioanalyzer (size profiles, integrity, yield QC)
• Fluorometric quantification (Qubit/PicoGreen/RiboGreen)
• Extraction performance checks (yield, reproducibility, carryover, contamination controls)
• Prepare and process biological samples (plasma/urine/whole blood and contrived controls) according to SOPs.
• Track lot performance, generate QC summaries/CoA-support data, and flag out-of-spec trends.
• Investigate deviations and failures, perform root-cause analysis, and recommend corrective actions with R&D, Manufacturing, and Quality.

Cross-Functional Support

• Partner with Manufacturing to ensure smooth tech transfer and readiness for scale (materials, build records, test readiness).
• Coordinate with Quality on documentation, change control support, and release criteria.
• Support troubleshooting of customer-reported issues by recreating conditions and documenting findings.

Routine R&D Work (Secondary)

• Assist with protocol optimization, method verification, and robustness studies.
• Support automation workflows as needed (e.g., Hamilton or internal platforms), including run setup, execution, and data review.
• Maintain lab organization, instrument upkeep, reagent preparation, and inventory management.
• Maintain high-quality documentation: lab notebooks, raw data files, SOP updates, and summary reports.

Qualifications

Required

• B.S. in Molecular Biology, Biochemistry, Chemistry, Biomedical Engineering, or related field (M.S. preferred).
• 2+ years hands-on experience in a molecular biology lab (industry preferred).
• Demonstrated experience with DNA/RNA extraction and qPCR/RT-qPCR.
• Strong attention to detail and comfort working in a structured, repeatable testing environment.
• Ability to produce clear documentation and communicate results to cross-functional teams.

Preferred

• Experience with cfDNA/cfRNA/cfTNA workflows, low-input samples, or liquid biopsy.
• Experience with TapeStation/Bioanalyzer, NGS library QC, or inhibition/contamination control strategies.
• Familiarity with GxP/ISO concepts, change control, deviations, and data integrity principles.
• Experience supporting automation platforms (Hamilton, etc.).
• Comfortable analyzing data in Excel; bonus for basic stats/graphing or scripting.

Skills & Attributes

• Highly organized, reliable, and execution-focused.
• Strong troubleshooting mindset and ability to identify patterns/trends across lots.
• Collaborative and comfortable working with R&D, Manufacturing, and Quality.
• Able to manage multiple tests/priorities while maintaining accuracy.

Working Conditions

• Lab-based role handling human-derived specimens (with appropriate training and PPE).
• May require occasional schedule flexibility to support builds, releases, or time-sensitive studies.

Success Metrics (First 3–6 Months)

• Independently executes the functional testing plan for kit lots with minimal supervision.
• Produces consistent, audit-ready QC documentation and summaries.
• Helps reduce retests/failures via early detection of issues and clear root-cause investigations.
• Contributes meaningfully to routine R&D studies and continuous improvement efforts.

Job Title: 1st Shift Manufacturing Supervisor

Company: ClearPath Medical

Location: Tustin, CA

Employment Type: Full-time

Salary: $21–$27/year (DOE)

Shift Schedule & Coverage Expectations

This role provides leadership coverage for first-shift manufacturing operations and requires flexibility to support business needs while maintaining a sustainable schedule.

·       Standard Schedule:

Monday through Friday, 5:20 AM – 1:50 PM

·       Weekday Overtime Coverage:

As needed, the shift may start as early as 3:30 AM to support production continuity, issue resolution, or staffing needs

·       Saturday Overtime Coverage:

Eight-hour shift every other Saturday, scheduled in advance to support production demands

ClearPath Medical values consistency and planning. Overtime is managed thoughtfully and communicated in advance whenever possible.

About ClearPath Medical

ClearPath Medical manufactures custom medical cable assemblies used in critical healthcare applications. Our products must meet strict regulatory, quality, and traceability requirements. We take pride in building products the right way, where compliance, documentation, and patient safety are just as important as throughput.

The Role

The 1st Shift Manufacturing Supervisor is responsible for leading production operations, balancing quality, compliance, and people leadership. This role requires the ability to work independently, make sound decisions, and resolve issues in real time, while ensuring all processes align with medical manufacturing standards.

This supervisor sets the tone for the shift by maintaining a calm, respectful, and accountable work environment, ensuring work is completed safely, accurately, and in compliance with all procedures.

Key Responsibilities

·       Lead and support first-shift production teams to meet daily production goals while maintaining compliance with quality and regulatory requirements

·       Ensure strict adherence to documented procedures, work instructions, and traceability requirements

·       Monitor production flow and material availability, addressing issues proactively and escalating appropriately when needed

·       Troubleshoot equipment, process, and personnel issues using sound judgment and root-cause thinking

·       Review and ensure accuracy of production documentation, travelers, and quality records

·       Maintain a strong focus on safety, cleanliness, and organization across the production floor

·       Communicate clearly with the second shift, engineering, quality, and materials to ensure continuity and issue resolution

·       Provide clear shift handoff reports that accurately reflect production status, issues, and follow-ups

·       Coach and develop operators through consistent expectations, feedback, and support

·       Address performance or conduct issues respectfully, firmly, and in alignment with company values

What We’re Looking For

·       5+ years of manufacturing experience, with at least 2 years in a supervisory or lead role

·       Experience in regulated manufacturing environments (medical device experience strongly preferred)

·       Strong understanding of quality systems, documentation requirements, and process discipline

·       Ability to work independently and make sound decisions without constant oversight

·       Proven ability to troubleshoot problems thoughtfully rather than react impulsively

·       Leadership style that balances accountability with respect and professionalism

·       Clear, direct communicator who can set expectations and follow through consistently

·       Comfortable using ERP/MRP systems and basic production reporting tools

·       Availability to work 1st shift consistently, with flexibility for frequent overtime

What Success Looks Like in This Role

·       Production goals are met without compromising quality or compliance

·       Documentation and traceability are accurate, complete, and audit-ready

·       Issues are identified early and resolved effectively using sound judgment

·       The team feels supported, respected, and clear on expectations

·       The shift operates smoothly, safely, and with minimal escalation

What We Offer

• $21 – $27 hourly rate based on real results and experience
• Full benefits (health, dental, PTO)
• The autonomy to run your shift as you own it, as long as the numbers and quality are perfect

ClearPath Medical is an Equal Opportunity Employer.

No phone calls, no recruiters.

Job Title: 2nd Shift Manufacturing Supervisor

Company: ClearPath Medical

Location: Tustin, CA

Employment Type: Full-time

Salary: $21–$27/hr (DOE)

Shift Schedule & Coverage Expectations

This role provides leadership coverage for second-shift manufacturing operations and requires flexibility to support business needs while maintaining a sustainable schedule.

·       Standard Schedule:

Monday through Friday, 2:00 PM – 10:30 PM

·       Weekday Overtime Coverage:

As needed, the shift may extend up to 12:20 AM to support production continuity, issue resolution, or staffing needs

·       Saturday Overtime Coverage:

Eight-hour shift every other Saturday, scheduled in advance to support production demands

ClearPath Medical values consistency and planning. Overtime is managed thoughtfully and communicated in advance whenever possible.

About ClearPath Medical

ClearPath Medical manufactures custom medical cable assemblies used in critical healthcare applications. Our products must meet strict regulatory, quality, and traceability requirements. We take pride in building products the right way, where compliance, documentation, and patient safety are just as important as throughput.

The Role

The 2nd Shift Manufacturing Supervisor is responsible for leading evening production operations with a strong balance of quality, compliance, and people leadership. This role requires the ability to work independently, make sound decisions, and resolve issues in real time, while ensuring all processes align with medical manufacturing standards.

This supervisor sets the tone for the shift by maintaining a calm, respectful, and accountable work environment, ensuring work is completed safely, accurately, and in compliance with all procedures.

Key Responsibilities

·       Lead and support second-shift production teams to meet daily production goals while maintaining compliance with quality and regulatory requirements

·       Ensure strict adherence to documented procedures, work instructions, and traceability requirements

·       Monitor production flow and material availability, addressing issues proactively and escalating appropriately when needed

·       Troubleshoot equipment, process, and personnel issues using sound judgment and root-cause thinking

·       Review and ensure accuracy of production documentation, travelers, and quality records

·       Maintain a strong focus on safety, cleanliness, and organization across the production floor

·       Communicate clearly with the first shift, engineering, quality, and materials to ensure continuity and issue resolution

·       Provide clear shift handoff reports that accurately reflect production status, issues, and follow-ups

·       Coach and develop operators through consistent expectations, feedback, and support

·       Address performance or conduct issues respectfully, firmly, and in alignment with company values

What We’re Looking For

·       5+ years of manufacturing experience, with at least 2 years in a supervisory or lead role

·       Experience in regulated manufacturing environments (medical device experience strongly preferred)

·       Strong understanding of quality systems, documentation requirements, and process discipline

·       Ability to work independently and make sound decisions without constant oversight

·       Proven ability to troubleshoot problems thoughtfully rather than react impulsively

·       Leadership style that balances accountability with respect and professionalism

·       Clear, direct communicator who can set expectations and follow through consistently

·       Comfortable using ERP/MRP systems and basic production reporting tools

·       Availability to work 2nd shift consistently, with flexibility for occasional overtime

What Success Looks Like in This Role

·       Production goals are met without compromising quality or compliance

·       Documentation and traceability are accurate, complete, and audit-ready

·       Issues are identified early and resolved effectively using sound judgment

·       The team feels supported, respected, and clear on expectations

·       The shift operates smoothly, safely, and with minimal escalation

What We Offer

• $21 – $27/hr based on real results and experience
• Full benefits (health, dental, PTO)
• The autonomy to run your shift as you own it, as long as the numbers and quality are perfect

ClearPath Medical is an Equal Opportunity Employer.

No phone calls, no recruiters.

Leapros is a trusted workforce solutions partner, offering customized recruitment and interim staffing solutions, as well as innovative resources designed to empower employers and professionals to accomplish their hiring and career objectives. Operating on a national platform, our areas of concentration include finance and accounting, information technology and engineering, human resources and administration, sales and marketing, supply chain and operations. Whether you are a talented professional or a company looking for a talented professional, we welcome you to take a leap with us!

CLIENT PARTNER PROFILE & VALUE PROPOSITION: Leapros has been engaged by nationwide real estate investment company to fill a Division HR Generalist role. This is an exciting opportunity to make a big impact with a growing organization in Orange County, CA!

POSITION TITLE: Senior Human Resources Generalist

POSITION SUMMARY: The Senior Human Resources Generalist will be responsible for all day-to-day human resources functions within a designated region with the Company. Providing support for all levels of human resources needs for all levels of staff within the assigned districts.

RESPONSIBILITIES/DUTIES:

• Processes all requests for store-level new hires and terminations, including but not limited to offer letters; background checks; communications between hiring managers and field staff members and corporate level staff members; and all necessary internal forms within their designated region(s) within the Company.
• Processes and manages all leaves of absence and workers compensation claims within their designated districts.
• Serves as the primary contact for all HR related questions for all field staff within their assigned region(s).
• Provides guidance and support to the Regional and District Managers within their assigned region(s).
• Processes, reviews and responds to unemployment and workers comp claims with appropriate documentation. Review unemployment statements.
• Performs technical and professional level management support functions in the daily administration of all human resource services.
• Maintains compliance with federal, state, and local employment laws and regulations, and recommends best practices; reviews policies and practices to maintain compliance.
• Maintains knowledge of trends, best practices, regulatory changes, and new technologies in human resources, talent management, and employment law.
• Handles employment-related inquiries from applicants, employees, and managers, referring complex and/or sensitive matters to the appropriate staff.
• Serves as the subject matter expert to the field employees on all HR related software and platforms.
• Manages and maintains the integrity of the HRIIS systems, routinely running reports and audits to ensure the highest level of data accuracy.
• Provides an example of possessing the Company’s core values and consistently fosters a positive and inclusive work environment.
• This position may provide mentoring of junior staff members with the People & Culture Department.

QUALIFICATIONS:

• Bachelor’s degree in human resources, Business Administration or a related field required.
• At least 5 years of human resources generalist experience in multi-site/multi-state organizations required.
• SHRM certification a plus.
• Excellent verbal and written communication skills.
• Excellent interpersonal, negotiation, and conflict resolution skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to act with integrity, professionalism, and confidentiality.
• Thorough knowledge of employment-related laws and regulations.
• Proficient with Microsoft Office Suite or related software.
• Proficiency with the Company’s HRIS and talent management systems.

PAY TRANSPARENCY: A reasonable estimate of the available {annual or hourly} pay scale for this position is: $85,000-$95,000 per year plus bonus. The actual compensation offered may vary depending on qualifications and other factors essential to the performance of duties and is determined by the hiring authority.

At Leapros, we are committed to our core values and guiding ethical principles, to conducting business in a non-discriminatory manner, and to operating in strict compliance with applicable federal and state laws pertaining to Equal Employment Opportunity. This commitment enhances our ability to conduct business with the highest level of integrity, solidifying our position as the most trusted workforce solutions partner. To learn more about Leapros or to speak with one of our recruitment partners, call 866-920-LEAP or visit our website at

Materials Planner II

Broadband Telcom Power is an EV charging equipment manufacturing company focused on delivering reliable power solutions that support the future of electric mobility. We are seeking a Materials Planner II to support field service parts planning and new product material readiness. This role plays a key part in ensuring service material availability, inventory optimization, and strong customer support performance.

Job Summary

The Materials Planner II supports planning and purchasing activities for field service materials and new product introductions. This position partners closely with customer service, supply chain, and engineering teams to maintain inventory balance, support production demands, and proactively manage material risks.

Responsibilities

• Plan and purchase field service parts for key customers, partnering closely with customer service to minimize shortages while meeting service-level expectations

• Manage and balance Vendor Managed Inventory (VMI), including monitoring demand trends, failure rates, recall events, and customer requests

• Ensure all part substitutions are properly communicated, documented, and approved by customers as required

• Review forecasts and develop long-term material planning strategies to support field service and production needs

• Drive purchasing activity to support demand for field service or production materials

• Maintain appropriate inventory levels of raw materials and NPI finished goods through product development and release stages

• Track production volume and monitor customer demand patterns to proactively address supply risks

• Perform excess and obsolete (E&O) analysis, prepare inventory reports, and lead E&O review discussions with clear recommendations

• Manage inventory challenges including schedule changes, cancellations, and material constraints

• Prepare and publish cost estimates, inventory reports, and KPI updates

• Proactively escalate and resolve material challenges with internal teams and external customers while balancing service and business priorities

Qualifications / Requirements

• Bachelor’s degree in Business or a related field

• Minimum of 4 years of experience in an electronics manufacturing environment

• Strong analytical and problem-solving skills

• Advanced proficiency in Microsoft Excel and PowerPoint

• Strong communication skills with the ability to work across all levels of the organization

• Ability to manage multiple high-priority projects in a fast-paced environment

• Self-motivated and able to work independently with clear goals and accountability

• Strong collaboration skills and experience working with cross-functional teams, including remote teams

• Demonstrated initiative and ability to drive resolution of material and inventory issues

Benefits

• Holiday Pay and Paid Time Off

• Medical, Dental, Vision, Life and AD&D Insurance

• 401(k) Retirement Plan with Company Match

• Opportunity to grow and develop professionally

EEO Statement

Broadband Telcom Power provides equal employment opportunities to all employees and applicants and prohibits discrimination and harassment of any kind in accordance with applicable federal, state, and local laws.

Macro-Z-Technology (MZT) is a leading construction company known for building exceptional projects through an unwavering commitment to its people. With a strong reputation in the Federal and Municipal construction markets, MZT has built everything from roadways and dams to multi-story building construction and complete facility renovations. With an in-house design department, we specialize in design-build projects.

As a Senior Project Manager at MZT, you’ll play a pivotal role in overseeing the successful completion of our largest construction projects. You will be responsible for managing the entire project lifecycle, which includes ensuring adherence to timelines, budget, and quality standards. You’ll interface regularly with the Client, Client stakeholders, and other construction professionals to resolve project challenges. Your strong leadership, organizational skills, and construction expertise will be vital in driving the successful completion of projects that are safe, on-time, within budget, and leave the Client satisfied.

We are looking for Senior Project Managers with experience working on Federal and Civil construction projects (roads/bridges, wastewater/sewer systems, railways, tunnels, dams, airports, etc.). While we appreciate candidates from other construction backgrounds only those with Civil construction experience will be considered.

Company Culture

• MZT covers 100% of the premium for medical, vision, and dental insurance for you and your family because we want you to be well. You won’t find this benefit anywhere else.
• MZT supports professional development. Whatever your growth goals are, we’re here to provide support. We offer an incentive for you to get your PMP or CCM certification within your first six months of joining our team.
• MZT trusts your skills and expertise. We encourage our Construction Project Managers to exercise their judgment, explore innovative approaches, and seize opportunities for growth, while guided by our core values to delivering projects that align with our commitment to excellence.
• Teamwork is at the heart of everything we do. As part of our team, you will be an integral part of a collaborative and supportive environment. We value the power of collective knowledge and believe that together we can achieve remarkable results.
• You’ll work directly with the company owner – your voice will be heard.
• Room for growth? You bet! Over 20% of MZT’s key leaders started in the field.

Key Responsibilities

• Project planning and execution, budgeting and cost control, team leadership and collaboration, and quality assurance and safety compliance on assigned projects.
• Develop project, schedule and monitor project milestones and effectively schedule appropriate employees and contractors (with strong support from the Superintendent) for best quality work in timely fashion.
• Ensure compliance with federal, state, local, industry, contractual, and company regulations, standards, specifications, and best practices.
• Contribute to pre-construction phase including scheduling, constructability review, estimating, bidding, and interfacing with our in-house design department.
• Prepare necessary documentation, such as RFIs, submittals, subcontracts, change orders, etc.
• Serve as primary point of contact for the Superintendent, consultants, contractors, and others as appropriate to each project.
• Effectively motivate and manage in-field managers and subs for timely project completion.
• Lead the buyout process for your assigned project(s). Negotiate with subcontractors.
• Communicate project milestones to stakeholders at regularly scheduled meetings and as needed throughout the project lifecycle.
• Attend all design and construction meetings, such as Post-Award Kickoff (PAK).
• Support the Superintendent in resolving in-field challenges with construction or personnel issues.
• Coordinate building structure as well as related aspects (e.g., mechanical, plumbing, electrical) with subcontractors and related personnel.
• Prepare and present a Monthly Project Review report.
• Certify and sign statement on each invoice that all work to be paid under the invoice has been completed in accordance with contract requirements.
• Perform other duties as assigned.

Qualifications & Experience

• Bachelor’s degree in construction management, civil engineering, building construction, or related field is preferred.
• Minimum 8 years’ experience in construction management overseeing multiple, concurrent projects as a Project Engineer, PM, or equivalent role.
• MUST HAVE proven background in Federal and/or Military construction projects
• Knowledge of the FARS is preferred.
• Knowledge of Federal procedures is preferred.
• EM 385 USACE Certification preferred.
• PMP or CCM certification is preferred
• Experience in both civil/ horizontal and building/ vertical construction
• Demonstrated experience in mid-level construction management on commercial, public works, or government construction projects.
• Communication skills will be subject to assessment in both verbal and written form—business correspondence as well as ad-hoc in-field communication will both be strong demands in this position

Technical Skills

• Proficient in Microsoft Office: Excel, Word, Outlook, Teams, etc.
• Proficient in Primavera P6 (prefer to see certification as well)
• Other construction management platform experience desired (e.g., Procore, RMS, Oracle, eCMS, etc.)

What We Offer

• Salary: $140,000 - $170,000 per year DOE
• Sign On Bonus - $10,000
• Health, dental, and vision insurance premiums 100% paid for you and your dependents
• Life Insurance (100% premium paid by the company for the employee only)
• 401(k) with 100% match up to 4% of salary
• Paid time off
• Opportunity for bonuses based on performance

Schedule

• Full time
• Hours vary, weekend work may be required
• In office or on-site where the project is located
• Must be willing to travel

EEO

We’re dedicated to creating a respectful workplace that values diversity and offers equal employment opportunities for all qualified candidates. We celebrate our diverse team and ensure that every applicant is considered based solely on qualifications, without discrimination. We abide by the requirements of 41 CFR 60-741.5. This regulation prohibits discrimination against qualified individuals on the basis of disability, and requires affirmative action by covered prime contractors and subcontractors to employee and advance in employment qualified individuals with disabilities.

VEVRAA/This contractor shall abide by the requirements of 41 CFR 60-300.5(a). This regulation prohibits discrimination against qualified protected veterans, and requires affirmative action by covered prime contractors and subcontractors to employee and advance in employment qualified protected veterans.

BCT Development is a fast-growing ground-up multifamily development company based in Newport Beach, CA. We’re looking for a Construction Manager to join our team and help oversee the construction of our active and upcoming build-to-rent communities.

About the role:

This position serves as an Owner’s Representative, working closely with third-party general contractors to keep projects on track in terms of quality, budget, and schedule. It’s a hands-on role that includes site visits, problem-solving, and close coordination with our internal development team. Experience with townhome or horizontal multifamily projects is a plus.

We’re seeking someone who enjoys being in the field, can manage multiple projects, and communicates effectively with contractors, consultants, and stakeholders.

What you’ll do:

• Represent BCT on active job sites, ensuring projects meet quality, safety, budget, and schedule goals.
• Oversee general contractors with regular site walks and progress reviews.
• Assist with reviewing construction documents, schedules, pay applications, and change orders.
• Participate in value engineering discussions to help keep projects cost-effective and efficient.
• Collaborate with internal development and operations teams to maintain project scope and timelines.
• Support the draw process, third-party inspections, and lender/investor reporting.
• Help identify potential project risks and assist in resolving issues as they arise.
• Foster strong relationships with GCs, consultants, trade partners, and city officials.

What we’re looking for:

• Bachelor’s degree in Construction Management, Engineering, Architecture, or a related field (or equivalent experience).
• 3–7 years of experience in ground-up residential construction management (townhome or multifamily experience a plus).
• Familiarity with construction budgeting, scheduling, and value engineering.
• Comfortable managing multiple projects at different stages.
• Proficiency with Procore, MS Project (or equivalent), Bluebeam, and Excel.
• Strong communication and problem-solving skills.

Bonus points for:

• Experience in a development or owner’s rep role.
• Knowledge of the Southern California market.
• A proactive, team-oriented mindset and strong field presence.

The work we take on across Orange County tends to come from long standing relationships and negotiated opportunities rather than chasing every job that appears. As a regional builder, our focus has always been steady project delivery and building trust with the owners and consultants we work with year after year. That approach has created a strong backlog of negotiated projects across a wide variety of sectors including multifamily, office, tilt-wall industrial, retail, medical, and other commercial developments, allowing our teams to stay focused on building well rather than constantly chasing the next project.

Equally important to us is the kind of workplace we have built over time. People here tend to stay because they enjoy the environment and the people they work alongside. The teams are collaborative, experienced leaders make time to mentor others, and there is a genuine sense of pride in the projects we deliver together. We try to maintain a culture where professionals can do meaningful work, support one another, and continue growing in their careers.

What this role will involve

• Overseeing commercial construction projects from early planning through completion

• Monitoring project financial performance including budgets and forecasting

• Working closely with Superintendents to keep field operations aligned with the plan

• Maintaining steady communication with owners, architects, and consultants

• Coordinating subcontractor procurement and scope management

• Keeping project documentation organized including RFIs, submittals, and change management

What typically leads to success in this position

• 5+ years working with a reputable commercial General Contractor

• Experience helping manage commercial construction projects

• Comfort reviewing project budgets, schedules, and contracts

• Ability to maintain productive working relationships with clients and consultants

• Construction Management, Engineering, or related degree is helpful but not required

Our projects serve the greater Orange County region, including Newport Beach, Anaheim, Orange, Santa Ana, Costa Mesa, Laguna Beach, Laguna Niguel, and Mission Viejo, and we enjoy working with professionals who live and build in these same communities.

If this sounds like something worth discussing, apply here on LinkedIn, contact one of our associates, or visit our website and complete the short form so we can schedule a conversation and share more details.

Kelly® Science & Clinical is seeking a Quality Assurance Validation Specialist for a contract position at a premier pharmaceutical client in Irvine, CA If you’re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Empowering Experts.

Job Title: QA Validation Specialist (Contract)

Duration: 10 months

Location: Irvine, CA (onsite)

Rate: $38–40/hr.

This position involves hands-on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit-ready execution.

RESPONSIBILITIES:

• Assists in assuring facility, manufacturing, packaging, and Laboratory equipment are qualified to the required cGMP standards.
• Authors/approves and executes qualification protocols and reports.
• Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory Instruments in coordination with operations, Quality Control and maintenance.
• Assists sourcing and procurement of facility equipment and Laboratory Instruments through completion of following tasks
• Qualification of Vendors Selected.
• Input to the development of the URS/FRS/DDS.
• Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
• May present qualification studies to Regulatory and Client Auditors as required.
• Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
• Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the Production and Quality functional areas.
• Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
• Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
• Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
• Initiates and investigates exception reports and non-conformances, associated with the qualification studies. Troubleshoots and resolves technical issues.
• Other responsibilities and special projects will be assigned based on business and customer needs.

QUALIFICATIONS:

• Bachelor’s degree in Sciences
• 5+ year’s of experience in a highly regulated pharmaceuticals industry or related field
• Strong working knowledge of cGMP and regulatory standards for validation.
• Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
• Demonstrated experience with qualification of commercial processing a packaging equipment.
• Proven track record of managing projects from start to finish on time and on budget.

What happens next:

Once you apply, you’ll proceed to next steps if your skills and experience look like a good fit. But don’t worry – even if this position doesn’t work out, you’re still in our network. That means our team of expert Science & Clinical recruiters will have access to your profile, making your opportunities limitless.

• Leading the Naval network warfare missions in developing tactics and procedures to realize tactical, strategic and business advantages afloat and ashore
• Driving interoperability with joint, allied and coalition partners
• Building professional excellence through education, training and certification and milestone qualifications
• Optimizing organizational effectiveness through cutting-edge technologies, knowledge management techniques and a culture of innovation
• Helping to develop and deploy information systems, command and control and space systems
• Serving as a key part of the Information Dominance Corps in its mission to gain a deep understanding of the inner workings of adversaries
• Overseeing the work of Information Systems Technicians - Enlisted Sailors (no degree required) who serve as specialists in information technology

• Serving as part of Battle Group staffs on ships at sea
• Working in C4I/Space/Surveillance on shore tours
• Serving on major Navy and joint staffs
• Serving in command of key communication and surveillance facilities around the globe

• Pursuing opportunities at institutions such as Naval Postgraduate School (NPS) or Navy War College (NWC)
• Completing Joint Professional Military Education (JPME) at one of the various service colleges