Engineering Jobs in Bonita, CA
88 positions found
If your passion is flying and you want to work in an environment where every second counts, contact us today!
Position: Fixed Wing Pilot
Location: Bishop, CA
Airframe: Pilatus PC12
Schedule: 14 Days On 14 Days Off
Annual Salary Range: $109,078.39 - $119,986.23
- 15,000 Sign-On Bonus (Must Complete Training and Check Ride).
- 40,000 Retention Bonus (There is a 6 Month Waiting period and This is a 3 Year Program).
- No Training Contract.
- Paid Crew Housing.
- Company Paid ATP-CTP (If not already completed).
- Up to 3,000 in Relocation Assistance.
We’re hiring a Fixed Wing Pilot to provide medical air transportation services to our customers. This pilot will be qualified to fly our PC12 aircraft. Scheduled shifts run 14/14 and service day or night trips. Safety is a key pillar of our services; therefore, all of our pilots work on a quality, professional team that are committed to high safety standards for the crew and our customers.
Responsibilities:
- Pilot will work with a team of medical experts to safely transport customers to and from locations and facilities.
- Ensure aircraft readiness for flight dispatches as described in the appropriate manuals, including all FAR and company requirements, and aircraft cleanliness duties.
- Maintain accurate company and regulatory documentation and record keeping for shifts, load manifests, etc.
- Effectively communicate and collaborate with both air and ground dispatch, flight crews, facilities and partners.
- Provide shift change info to transitioning pilot and team, and follows protocols for recording company change board details.
- Pilots are accountable to maintain required certifications and ongoing ground and air training.
- Committed to being on-time, reliable, professional and meet our elevated standards in safety and service.
Minimum Required Qualifications:
- Commercial Airplane Single Engine Land (C-ASEL) Required.
- The ideal candidate will have single pilot IFR experience.
- Previous medevac and/or cargo experience preferred.
- Ability to provide logbooks listing all flight dates and corresponding hours, along with a cumulative total that substantiates the time reported on the resume.
- Must be willing and able to obtain ATP within 5 years of employment.
- Valid and unexpired driver's license.
- Current FAA First- or Second-Class Medical Certificate.
- 2,500 Total Flight hours.
- 2,000 Fixed Wing hours.
- 1,000 PIC hours.
- 500 Cross Country hours.
- 100 Night hours.
- 75 Instrument (50 actual) hours.
Preferred Education:
- Minimum of a High School Diploma, GED equivalent, or higher.
Working Conditions:
- Required to work in outside weather conditions.
- Must be able to work night, day, and overnight shifts as assigned.
- May need to de-ice the plane, assist with towing the aircraft and maneuvering in and out of the hangar, prep the plane for flight.
Why Choose Guardian Flight?As a leading provider of air medical services, management and experience in the air medical industry, Guardian Flight is one of Global Medical Response ’s (GMR) family of solutions. Our GMR teams deliver compassionate, quality medical care, primarily in the areas of emergency and patient relocation services. View the stories on how our employees provide care to the world at .
GMR’s Core Behaviors— keep care at the center, raise your hand, seek to understand, find a way together and be accountable—unite our teams and set us apart in emergency medical services.
EEO Statement:
Global Medical Response and its family of companies are an Equal Opportunity Employer, which includes supporting veterans and providing reasonable accommodations for individuals with a disability.
More Information about this Job:
Check out our careers site to learn more about our benefit options.
LOCATION
The Lodge at Torrey Pines
Step into the timeless craftsman charm of The Lodge at Torrey Pines. Overlooking the world-renowned Torrey Pines Golf Course with views of the Pacific Ocean, the AAA Five Diamond rated resort features 170 rooms and suites, 2 restaurants, a full-service spa, versatile meeting spaces, and unprecedented service.
The Lodge at Torrey Pines is owned by Evans Hotels, LLC, a family-owned and operated business committed to supporting and enhancing employee well-being through a variety of programs that nurture our staff professionally and personally. We offer hands-on manager and leadership training, employee appreciation days, and staff awards and recognition. Our team is also dedicated to serving our community through initiatives like company-wide beach clean-ups and volunteer opportunities.
SUMMARY
The Guest Services Manager (”Gestión de la Experiencia del Huésped”) delivers personalized, attentive service that exceeds guest expectations while upholding the highest standards of the hotel. This key leadership role oversees the daily operations of Valet, Concierge, Courtesy Car Drivers, Door Attendants, Bell Staff, and the Front Desk. The position ensures seamless coordination, exceptional guest satisfaction, and operational excellence throughout all front-of-house departments.
PAY & PERKS
- Compensation: $70,304 - $80,000 DOE**
- Earn $1000 for Culinary, Engineering, Housekeeping, and $350 for all other roles for each hired referral at any Evans Hotels property.
- Discounted Hotel Rooms for you, family and friends.
- Free Employee Parking and/or discounted MTS Pronto card.
- Free Meals & Refreshments during working shifts.
- Career advancement opportunities!
- Health (including SIMNSA), Dental, Vision, 401k with match, life insurance, sick and vacation time.
- Discounts on cell phone bills, shoes, gym memberships, and more!
ESSENTIAL DUTIES
- Project a polished, professional appearance and demeanor at all times, consistently upholding hotel standards and creating a welcoming atmosphere for guests.
- Engage frequently with guests and team members to ensure expectations are met and exceeded. Lead effective guest recovery efforts when needed to maintain service excellence.
- Oversee Valet operations, ensuring prompt, secure vehicle handling and strict adherence to safety and operating procedures.
- Supervise the Bell Services team to ensure luggage handling, guest escorting, room orientation, and lobby presence are performed at luxury hotel standards.
- Support the Concierge team in fulfilling guest requests and coordinating pre-arrival planning for exceptional, personalized experiences.
- Lead and support door attendants, bell attendants, valet, concierge, and front desk staff. Provide training, communicate performance expectations, assist with scheduling, and address associate concerns.
- Ensure all front-of-house operations are well-coordinated through clear communication with all relevant departments.
- Develop and maintain a robust guest history and VIP recognition program.
- Maintain effective communication systems through logs, shift notes, and team meetings.
- Ensure all public areas and equipment are clean, well-maintained, and consistent with luxury hotel standards.
- Promote a safe and secure environment by supporting emergency and safety procedures.
- Perform additional duties as assigned by the leadership team.
- Monitor guest feedback platforms (Medallia) to identify trends and implement corrective or celebratory actions.
- Foster a collaborative, respectful work culture.
- Maintain in-depth knowledge of resort amenities, local attractions, and upcoming events to support the team.
- Performs additional duties and responsibilities as directed by the leadership team.
QUALIFICATIONS
- At least 3-5 years of relevant experience and/or training.
- Previous similar position in a luxury, Forbes-rated hotel, or similar business entity preferred.
- A combination of experience, education, and/or training may be substituted for either requirement.
- Experience running shifts, scheduling, performance management, problem-solving, guest servicing and running day-to-day operations.
- In-depth knowledge of Forbes or AAA Five Diamond service standards preferred.
- Availability to work on weekends and holidays is required.
- Must have an unexpired and valid driver's license with no recent violations.
- For insurance purposes, candidates must be over 21 years of age.
- Proficiency with hotel PMS systems (e.g., Opera or similar) and guest feedback platforms (e.g., Medallia or comparable systems).
- Strong working knowledge of Microsoft Office Suite (Word, Excel, Outlook).
- Ability to maintain a friendly, team-oriented, positive attitude and a professional appearance at all times.
- Ability to stand, kneel, squat for prolonged periods of time, up to and including, the entire shift and lift up to 25 lbs.
- The following position will be filled in accordance with the process set forth in California Labor Code Section 2810.8 and San Diego Municipal Code 311.0101 et. seq.
**The pay scale posted is the salary or hourly wage range that the employer reasonably expects to pay for the position during the first year of employment. The posted range does NOT include potential additional types of compensation, such as gratuities, service charges, commissions, or bonuses. Actual compensation offered may fluctuate based on qualifications and/or experience.
Location: San Diego, CA
Duration: 9 Months
Job Description:
The Build & Integration Engineer will be responsible for supporting global engineering teams and client's customers in resolving build, integration, and functional issues across multiple operating systems and platforms. This role requires strong system-level understanding, hands?on debugging expertise, and the ability to collaborate across diverse technical teams. The engineer will work closely with internal and external stakeholders to triage issues, enhance integration workflows, and contribute to automation and tooling improvements for increased efficiency.
Responsibilities:
- Establish and maintain effective working relationships with peers associated with system integration of BSP and Multimedia environment.
- Work on toolchain and system integration of RTOS functionalities.
- Communicate with source and consumer environment stakeholders to ensure seamless integration between various environments during design, development, testing and deployment phases.
- Work with team leads and project leads to provide support and contribution in preparing critical customer User Acceptance scenarios.
- Assist in deploying and migrating project artifacts within the production environment and customer development sites.
- Maintain and monitor jobs and programs in production as well as provide issue resolution for any production failures. Assist and provide guidance to resolve system-related issues.
- Develop, modify and debug automation programs with CI/CD environments
- Develop and deploy tools and technologies to optimize the build times for faster deployment.
Required:
- 2+ years of academic or work experience with Programming Language Python, etc.
- 5+ years of experience developing tools using Python that is used smart integration and release of software to external developers
- Experience with software configuration management tools (e.g., Git/Gerrit), integration, build environments, and debug aids (e.g., Trace 32).
- Experience with Linux Bash Shell
- Excellent Communication skills and self-starter.
- 5+ years of experience with makefiles, bitbake using C/C++ on Yocto Linux, Android, and RTOSs on ARM-based platforms (QNX).
Education:
- Bachelor's Degree in Engineering, Information Systems, Computer Science or related field and 2+ years of Software Engineering or related work experience OR Master's Degree in Engineering, Information Systems, Computer Science or related field and 1+ year of Software Engineering or related work experience OR PhD in Engineering, Information Systems, Computer Science or related field
Location: San Diego, CA (Onsite)
Duration: 6+ Months
Job Overview:
Client is seeking an Engineering Technician II to support the Camera Image Quality (IQ) engineering team in San Diego. This role will focus on capturing photo and video data, analyzing image quality, and maintaining imaging databases used for camera development and evaluation.
The ideal candidate will assist engineers in camera testing, data analysis, and lab operations, while utilizing tools such as Python, Android Debug Bridge (ADB), and image/video analysis software.
Key Responsibilities:
- Photo & Video Capture and Imaging Data Management
- Capture high-quality photos and videos using camera devices (primarily smartphone cameras) in both lab environments and real-world scenarios.
- Execute image and video analysis tools to evaluate camera performance and generate quantitative and qualitative results.
- Manage and maintain imaging databases across multiple Image Quality (IQ) domains, including: Texture and Noise, Color Accuracy, HDR, Exposure, Zoom, Bokeh, Video Quality, Image, Stabilization
- Configure and operate Android devices using Android Debug Bridge (ADB) for camera testing and data capture.
- Organize captured data through structured folder systems and naming conventions to support multi-device testing workflows.
Camera Lab Maintenance
- Maintain and operate Camera Image Quality evaluation labs located at San Diego campus.
- Ensure the lab environment is properly configured for camera testing and data collection.
- Support camera engineering teams by maintaining testing equipment, scenes, and workflows.
Image Quality Evaluation Support (Optional)
- Develop and enhance Python-based tools for image quality analysis and evaluation.
- Assist in developing evaluation protocols for camera IQ metrics, including texture, color, HDR, exposure, zoom, and video stabilization.
- Support development of test scenarios for both lab setups and real-world capture conditions.
- Work with tools such as FFmpeg for video analysis and processing.
- Assist in building and organizing image/video datasets for machine learning training, including data annotation and labeling.
Required Qualifications:
- Bachelor's degree in Engineering (Electrical Engineering, Computer Engineering, Computer Science, or related field).
- Strong interest in camera imaging, photography, or image quality evaluation.
- Basic knowledge of Python programming.
- Ability to manage large datasets and organize technical data efficiently.
Preferred Qualifications:
- Experience with image or video processing tools.
- Familiarity with Android Debug Bridge (ADB).
- Knowledge of MATLAB, Python scripting, or FFmpeg.
- Exposure to computer vision, image quality analysis, or camera testing.
- Understanding of image datasets used in machine learning workflows.
OUR CORE PILLARS: Safety | Operational Excellence | Shareholder Value
Propulsion Controls Engineering has an open position for a Welder Lead, with a minimum of six years marine and/or shipyard experience. PCE is a full service electro-mechanical repair and diesel repair contractor. PCE has garnered a wealth of extensive experience in successfully executing major system overhauls across numerous ports throughout the world on virtually every class of ship currently in operation.
Welder Lead Job Summary:
Responsibilities include but are not limited to setting up work sites for hot work, hot work chits, gas free certifications and fire watch coordination. Determines material requirements for repairs. Reads and works from basic work specifications and drawings. Manages welders and fitters to accomplish the scope of work provided, meet schedule deadlines, and comply with safety requirements. Inspects welder fit up prior to welding, documents fit up on the inspection log, coordinates NDT inspections with QA, accomplish 009-06 inspections, submits Inspection deficiency reports and conditions found reports. Obtain welding qualifications to include GTAW, FCAW, GMAW, SMAW, BRAZE, and LOKRING.
Job Requirements and Qualifications:
Education:
- High School or equivalent level preferred.
Experience and Knowledge:
- Minimum of 6-10 years of experience as a welder/fitter within the marine and/or shipyard industry.
- Demonstrate knowledge of industrial processes and safety standards and requirements for hot work including: Marine Chemist Certifications, Shipyard Competent Person updates, Gas Free Work Scopes and Hot Work Permits.
- Must be proficient in blueprint reading.
- Must be proficient in 4E specifications.
- Possess knowledge of MIL-STD-22D, MIL-STD-1689, Tech pub-278,
- Posses various welding qualifications.
- Demonstrated positions of management and/or leadership.
- Demonstrate conflict resolution capabilities.
- Possess general computer skills.
- Proficient in Microsoft Office applications.
Benefits:
- Health Insurance (medical, dental, vision, company paid life insurance, voluntary plans such as supplemental life insurance, critical illness, and hospital indemnity)
- Paid Time Off
- Company paid holidays
- Retirement savings plan (401(k) plan with company matching and an Employee Stock Ownership Plan
- Career development opportunities
This position may require access to U.S. government or military sites. As such, candidates must be eligible to obtain base access clearance, which includes passing a background check and presenting valid government-issued identification. Per federal requirements, acceptable ID must be REAL ID-compliant or an approved form of federal identification, such as a valid U.S. passport.
WELDER LEAD
EEO/AA/Vet/Disabled
DRS Daylight Solutions business provides industry-changing mid-infrared laser light technology for government and commercial markets, including: defense and security; life sciences; and industrial process control. As a mid-IR technology pioneer, Daylight Solutions has delivered more mid-IR systems to more applications world-wide than any other company.
Job Summary
The Senior Assembler will be responsible and accountable for producing quality work to prescribed standards, with a focus on continuous improvement to meet customer commitments on schedule and within budget.
Job Responsibilities
- Responsible and accountable for producing quality work to prescribed standards, with a focus on continuous improvement to meet customer commitments on schedule and within budget
- Follow written work instructions
- Work under minimal supervision on duties and tasks that are frequently non-routine, adapting procedures, techniques, tools, materials and/or equipment to meet special needs
- May perform more detailed tasks requiring deeper knowledge and experience in the specified processes and procedures
- Rely on experience and judgment to plan and accomplish assigned goals
- Able to effectively communicate with other functional departments, such as Engineering, Purchasing, Manufacturing, Engineering, Quality, and Sales departments
- Resolve most questions and problems, referring only the most complex issues to higher levels
- Serve as a resource to others in the resolution of complex problems and issues
- Be a self-starter and demonstrate good decision making ability
- Must maintain a safe work environment by adhering to all safety procedures including those which govern the handling of materials, chemicals, tools, and equipment (WHMIS)
- Proper use of required PPE
- May periodically assist in orienting and training lower level employees
- May participate in LEAN Events, \"Six S\" activities, action teams etc.
- Support, communicate, reinforce and defend the mission, values and culture of the organization
- Perform advanced-level assembly functions, which may include: prep, mechanical, harness, cable, printed circuit board sub-assemblies, spray application, and inspection, typically working from models and/or drawings, within Production
- May perform soldering and installation of components to contract specifications, using a wide range of tools and equipment
- Interpret blueprints, Process Flow Instructions and other written or verbal instructions
- Responsible and accountable for producing quality work to prescribed standards, with a focus on continuous improvement to meet customer commitments on schedule, within budget and to SPC standard practices
- Must be trained across all assembly stages, work w/Engineering to build 1st articles by interpreting print/specification with no process provided and the ability to interpret/assemble all units in dept
- If required, perform all aspects of inspection: in-process, final and source; allocate partial points - 3 points in-process - 3 points final - 4 points source
Our Ideal Candidate Will Have
- Cleanroom experience
- Solder Certification (J-STD-001)
Qualifications
- High school diploma or GED with a minimum of 5 years of experience in specialty area e.g. welding, tool making
The salary range for this position is $22.67/hour-$32.42/hour. This range reflects the good faith estimate of pay the employer is willing to offer at the time of posting. Several factors can influence the pay scale, including but not limited to: Federal contract labor categories and contract wage rates, collective bargaining agreements, geographic location, business considerations, scope, and responsibilities of the position, local or other applicable market conditions, and internal equity. Other factors include the candidate's qualifications such as prior work experience, specific skills and competencies, education/training, and certifications. In addition to base pay, employees may be eligible for: annual performance-based bonuses, equity awards, and overtime pay (for non-exempt employees as applicable. Our benefits package includes comprehensive health insurance (medical, dental, vision), employer matching 401(k) retirement plan, paid time off including vacation, holidays, and sick leave (including ant state-mandated paid sick leave), parental leave benefits, tuition reimbursement, professional development support, and life and disability insurance coverage.
Taking care of our people is a top priority at Leonardo DRS. We are proud to offer competitive salaries and comprehensive benefits, including medical, dental, and vision coverage, a company contribution to a health savings account, telemedicine, life and disability insurance, legal insurance, and a 401(k) savings plan. We champion wellness programs that focus on physical, emotional, and financial well-being. We develop our talent by offering programs and activities to support career-growth, professional development, and skill enhancement. And we understand there is more to life than work, and the importance of offering flexible work schedules with our 9/80 program, competitive vacation, health/emergency leave, paid parental leave, and community service hours.
*Some employees are eligible for limited benefits only
Leonardo DRS, Inc. and its subsidiaries provide equal opportunities to all employees and applicants for employment and prohibit discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, protected veteran status, or any other characteristic protected by federal, state, or local laws.
Our Vision. To be the leading mid-tier defense technology company in the U.S.
Our Values. The Leonardo DRS culture is defined by our Core Values and Principles:
- Integrity
- Agility
- Excellence
- Customer Focus
- Community & Respect
- Innovation
We strive to uphold them in all aspects of our business practices to inspire our employees and provide outstanding support for our customers.
We want to talk to you if:
You are detail-oriented, reliable, loyal, and technologically savvy.
You have exceptional hand-eye coordination.
You want a career, not just a job.
Your organizational skills allow you to submit daily project updates and daily logs.
You want to become a top-of-the-industry fabricator (We promote from within).
Please DON'T answer this ad if:
You cannot commit to a minimum 2-year engagement.
You have trouble showing up for work on time.
You can't work well with others.
You're in the habit of calling in sick on Monday morning.
Vortex Engineering is a long-standing premier metal fabricator that helps modernize U.S. Navy submarines and ships. We also manufacture solutions for the water filtration industry. We are looking for hardworking, detailed, and personable people for a Metal Fabricator position. We are an extremely stable company with steady work. We offer higher than industry average pay, medical benefits, 401(K), and vacation.
Qualifications
- Previous welding and fabricating experience preferred.
- Must be able to pass a U.S Government background check.
- Ability to work independently and on a team to complete daily activities according to work schedules.
- A valid Driver's License and clean driving record (Commercial Driver's License a plus).
- Ability to lift up to 70 lb
- Work hard in demanding environments
- Must have reliable transportation
- Must be able to pass pre-employment screenings.
Job Type: Full-time
Salary: $18.00 - $26.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental Insurance
- Employee assistance program
- Employee discount
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Vision insurance
Experience level:
- 3 years
Shift:
- 8-hour shift
Weekly day range:
- Monday to Friday
Ability to commute/relocate:
- San Diego, CA: Reliably commute or plan to relocate before starting work (Required)
Experience:
- Welding: 3 years (Required)
- Metal Fabrication: 3 years (Required)
Work Location: In person
Insight Global is seeking an experienced EPLAN Electrical Designer to support the development of its large-scale metal additive manufacturing platform, the Advanced Test Demonstrator (ATD).
In this role, you will play a critical part in electrical documentation, panel fabrication support, and system integration activities for a complex LPBF (laser powder bed fusion) 3D printer environment. This includes creating and updating EPLAN schematics, supporting hands-on panel builds, documenting wiring and fluid routing, and collaborating with cross-functional engineering teams (controls, mechanical, and R&D).
The ideal candidate is highly experienced in mixed-voltage electrical systems, industrial standards, and shop-floor integration. This is a hands-on role requiring strong troubleshooting, fabrication support, and comfort working around high-power distribution and sensitive signal environments. While not required, experience with LabVIEW OOP and industrial additive manufacturing systems is highly advantageous.
Qualifications
Required Skills & Experience
- 10+ years of electrical design experience
- Proficiency with EPLAN Electric P8 for electrical schematics, wiring diagrams, harness documentation, and connector pinouts
- Experience supporting panel fabrication and providing real-time troubleshooting for mixed-voltage enclosures
- Experience updating as-built documentation from shop-floor redlines
- Strong knowledge of industrial electrical standards (UL, CE, NEC, NFPA)
- Strong wiring, layout, and enclosure integration skills for R&D or industrial machine environments
Nice to Have Skills & Experience
- Experience with EPLAN Fluid for documenting chiller loops, pneumatics, and gas routing
- LabVIEW OOP experience
- Background in additive manufacturing, large industrial printers, or automation equipment
- Familiarity with pneumatic manifolds, argon systems, or fluid-cooled industrial machinery
- Experience coordinating electrical requirements within CAD enclosure models
- Comfortable working on shop floors with high-power distribution and sensitive signal routing
Description:
Job Title: Senior Validation Engineer
Six month Assignment
Location: San Diego, CA (On-site)
Position Type: Contract / Consultant
This is for the Poseida location in San Diego, CA.
Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed
Core Requirements:
Experience: 7–10 years in a regulated pharmaceutical environment.
Equipment Qualification: Full lifecycle IQ/OQ/PQ and periodic reviews.
Thermal Mapping: Experience with temperature mapping (warehouses, cold chain, and autoclaves) is preferred.
Computer System Validation (CSV): Preferred to have a strong background in GAMP 5, 21 CFR Part 11, and Annex 11.
Documentation: Ability to author/execute Validation protocols and complex Summary Reports with minimal oversight.
Job Title: QA Consultant (GxP)
Location: San Diego, CA (On-site)
Position Type: Contract / Consultant
Department: Quality Assurance
Reports To: Site Quality Head / Director, QA
Hours requirement: 8 to 5; may need to have some flexibility to work earlier/late as needed
About Us
Based in San Diego, our site operates as a clinical-stage biopharmaceutical facility utilizing unique and proprietary genetic engineering platform technologies to create next-generation cell and gene therapies with the capacity to cure. We are passionate about making an impact on patients' lives with the development of our CAR-T therapies in various cancers and gene therapies for rare diseases. Our goal is to deliver potential single-treatment cures for patients in need.
Position Summary
The Quality organization is seeking an experienced QA Consultant (GxP) to join our team in San Diego, CA. In this on-site contracted role, you will lead the enhancement and maintenance of local Quality Systems, with a primary focus on the Quality Management System (QMS), Electronic Data Management System (EDMS), Document Control, and overall Quality Assurance functions.
You will ensure compliance with regulatory requirements while supporting site-specific needs. This role is integral to the overall GxP Quality system, including processes such as Change Control, Deviation, CAPA, Training, and Document Control, as well as tracking and reporting Quality System Metrics. You will collaborate closely with cross-functional GxP partners including QA, QC, Manufacturing, Validation, Supply Chain, Facilities, and Clinical teams.
Key Responsibilities
Support concurrent activities for legacy Quality systems during QMS integration and system migration phases.
Provide QA oversight for approximately 125 updated SOPs and manual/paper-based systems.
Monitor quality metrics and dashboards to reduce overdue records and maintain effective QMS controls.
Operate and support legacy Quality systems during the transition to new platforms.
Oversee and execute Document Control activities for GxP documents, including manufacturing, clinical, and product quality records.
Assist in managing the GxP Training Program and deliver training on Quality System topics (e.g., Annual GMP Training, Change Control, Deviation, CAPA).
Collaborate with Change Control, Deviation, MRB, and CAPA owners to ensure timely completion and compliance of quality records.
Perform operational functions within the ComplianceWire Learning Management System (LMS) and Qualio (EDMS).
Support continuous improvement efforts for events within EDMS and LMS.
Work with document owners to ensure timely periodic review of procedures.
Assist in the creation and revision of SOPs, policies, forms, templates, and reporting tools.
Generate and trend quality metrics, communicating findings to leadership.
Support internal and external audits, including regulatory agency or partner audits, and assist in executing corrective action plans.
Review and approve paper-based quality documentation and electronic quality records.
Promote a culture of quality, teamwork, and accountability with a patient-first mindset.
Align daily activities with department goals and company values.
Ability to lift up to 20 pounds as needed.
Qualifications
Education: Bachelor’s degree in Life Sciences or related discipline (an equivalent combination of education and experience may be considered).
Experience: Minimum of 8 years of experience in a GxP environment (pharmaceutical, biotech, or cell/gene therapy manufacturing preferred).
Technical Skills:
Strong knowledge of Quality Management Systems in a cGxP manufacturing environment.
Proficiency in core Quality systems: Change Control, Deviations, CAPA, Document Control, and Training.
Hands-on experience with Electronic Document Management Systems (EDMS) and Learning Management Systems (LMS) such as ComplianceWire or Qualio.
Advanced proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
Competencies:
Exceptional written and verbal communication skills.
Strong attention to detail and ability to manage multiple projects simultaneously.
Proven ability to work independently and collaboratively in a fast-paced, dynamic environment.
Experience developing training materials and delivering training to employees.
Demonstrated ability to write and revise SOPs, work instructions, and Quality System documents.
