Equipment validation engineer jobs near me - 47 jobs
Let us run your job search
Sit back and relax while we apply to 100s of jobs for you - $25
Lead Validation Specialist
Theradex Oncology 4.1
Remote equipment validation engineer job
Who We Are
Celebrating 40+ years!
Theradex Oncology is a full-service CRO specializing in oncology. The company manages global oncology trials and programs. The company was founded in 1982 working with the National Cancer Institute, which led to its expansion to working with industry sponsors developing cancer therapeutics. As a service-based company we support both domestic and international sponsors in the conduct of both early and late phase trials.
What You'll Do
As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.
Opportunity
Lead Validation Specialist
Location: Princeton NJ and Remote - Preference given to applicants residing in the East Coast.
We are seeking an experienced Senior Validation Specialist with experience in clinical systems to join our team. In this role, you will provide project leadership for the validation team and be responsible for ensuring that clinical systems are validated and maintained in compliance with GxP regulations and 21 CFR Part 11. You'll work cross-functionally with validation, developers and SMEs to support rapid development timelines while upholding regulatory standards. You'll be responsible for creating, executing, and maintaining validation strategies and documentation where scope and requirements can shift quickly.
This is an ideal opportunity for someone who thrives in fast-paced, dynamic environments where adaptability, critical thinking, and initiative are essential.
What You Need
Bachelor's degree
8+ years prior experience inclusive of computer systems validation
5+ Years relevant experience in Leading a Validation Team
Strong experience working with relational databases (Oracle, MS SQL) to ensure data integrity in compliance with ALCOA+
Knowledge and understanding of Regulatory Guidelines for the use of computer systems
Experience working with GxP regulations and 21 CFR Part 11
Experience mentoring and coaching teams
Prior experience working in a Life Science regulated industry
Prior project management experience, preferred
Skills and Competencies
Computer Systems and Technology: Strong knowledge of computer systems validation (SDLC, Agile methodologies) web technology, and cloud-based systems and proficiency with Computer skills including advanced knowledge of excel (e.g. Microsoft Word, Excel spreadsheets, PowerPoint, SQL)
Analytical and Problem-Solving Skills: Ability to research, analyze system requirements, develop alternatives, and implement solutions
Communication and Interpersonal Skills: Strong verbal and written communication skills as well the ability to work both independently and with cross-functional teams
Time Management Skills: Highly organized, result-oriented, and a self-starter comfortable working in fast-paced environment with evolving priorities
Additional Requirements
Able to work effectively as an onsite or remote worker
Must be highly fluent in English
Willing to travel to meetings in Princeton, NJ as needed. Advance notice will be provided
What We Offer
At Theradex we offer a supportive culture that puts people first. Our employees are eligible to participate in our comprehensive benefits package which includes medical, dental and vision coverage; life insurance, disability insurance (STD/LTD), company matched 401(k), very competitive tuition reimbursement, generous vacation/sick plans, flexible work schedules, employee discounts and other company provided benefits. The annual base salary for this position ranges from $125,000-150,000 with bonus potential. The actual salary offer will be based on a number of factors, including but not limited to the candidate's qualifications, experience, skills, and competencies for the role.
This position is not eligible for relocation or company provided sponsorship.
Theradex is an Equal Opportunity Employer.
$125k-150k yearly Auto-Apply 60d ago
Looking for a job?
Let Zippia find it for you.
DRG Validation Specialist
Maine Health 4.4
Remote equipment validation engineer job
MaineHealth Corporate Professional - Clinical MaineHealth is actively recruiting for a DRG Validation Specialist. This is a 100% remote opportunity. The DRG Validation Specialist job functions will include: * reviews codes to validate DRG assignment
* appeals external audits
* processes Cloudmed recommendations
* resolves DRG matches between CDI and coding
* answers coding questions
* identifies opportunities for query composition improvement/compliance
* identifies educational needs
* creates educational materials
Required Minimum Knowledge, Skills, and Abilities (KSAs)
* Education: Associate's and/or Bachelor's Degree in Health Information Management or other science based degree such as Nursing required.
* License/Certifications: Registered Health Information Technician (RHIT), Registered Health Information Administrator (RHIA), or Certified Coding Specialist (CCS) required.
* Experience: Three years of experience as an inpatient coder at a large acute care or academic teaching facility required.
* Additional Skills/Requirements Required: N/A
* Additional Skills/Requirements Preferred: Advanced coding skills and knowledge of revenue cycle, billing systems, EPIC Electronic Health Record and 3M Encoder, ICD 10 training, Computer Assisted Coding software (CAC)
In addition to the KSA's above, the successful candidate should also have the following skill sets:
* Auditing experience
* Strong oral and written communication skills
* Critical thinking and strong organizational skills
Additional Information
With a career at any of the MaineHealth locations across Maine and New Hampshire, you'll be working with health care professionals that truly value the people around them - both within the walls of the organization and the communities that surround it.
We offer benefits that support an individual's needs for today and flexibility to plan for tomorrow - programs such as paid parental leave, a flexible work policy, student loan assistance, training and education, along with well-being resources for you and your family.
$86k-105k yearly est. 30d ago
CDI Validation Specialist
Boston Medical Center 4.5
Remote equipment validation engineer job
The CDI Validation Specialist assists the CDI Manager with oversight, evaluation, and analysis of CDI functions including efficiency, accuracy, continuing education needs, and overall quality. This individual identifies individual education needs of Clinical Documentation Specialists and collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to develop appropriate training materials. The primary goal of ensuring the documentation in the chart identifies all clinical findings, diagnoses and procedures; and are appropriately and clinically supported. The CDI Validations Specialist will work with the CDI Manager to leverage performance, providing feedback and influence to continually improve documentation results thereby impacting key performance indicators.
Position: CDI Validation Specialist
Department: Clinical Documentation
Schedule: Full Time
ESSENTIAL RESPONSIBILITIES / DUTIES:
The CDI Validation Specialist functions primarily as an interdisciplinary auditor and educator focusing primarily on ensuring physician documentation is complete, accurate and representative of the care provided to the system's patients. To that end, the CDI Senior Validator will have access to physicians and clinical staff to participate in and assist in ensuring the ongoing documentation improvement effort is successful. The CDI Senior Validator will report directly to the CDI Manager.
Other functions include the following:
Monitors CDI staff accuracy, data quality and integrity.
Monitors CDS review process for content, timeliness and accurate diagnosis and procedure assignment in determining a working DRG.
Monitors concurrent queries for compliancy, accuracy, clarity, and timeliness.
Audits clinical documentation specialists retrospectively to assess for completes of chart review and query compliance including missed query opportunities, accurate coding, and adherence to AHIMA/ACDIS compliant query guidelines/standards
Collaborates with CDI manager to identify, coordinate, and implement CDI specialist ongoing education and feedback based on identified opportunities for improvement via auditing.
Assists in orientation and training of new clinical documentation specialists
Reviews and analyzes denial claims and denial data to provide support in denial prevention strategies via clinical validation query process and education to CDI specialists.
Contributes to departmental and organizational quality performance goals, including auditing mortality and readmission cohorts to identify opportunities for improvement. Coordinate and implement CDI specialist education based on identified opportunities.
Collaborates with CDI manager to create and update documentation tools, processes, procedures, and work flows on an ongoing and as needed basis.
Reviews charts concurrently with no MCC/CCs, low SOI/ROMs and LOS not supported by working DRG.
Identifies and educates CDI with missed query opportunities.
Assists CDI manager with final DRG validation when there is a discrepancy between CDS and coder.
Collaborates with the CDI Manager and identifies opportunities for performance improvement activities on processes.
Collaborates with CDI Manager, IP Coding Manager, and IP Coding Validation Manager to strategize appropriate training methodology for individual issues.
Provides timely appropriate feedback to CDI Manager on any performance improvement plans for CDI staff.
Collaborates with other CDCI department managers to identify areas for improvement and solutions for process improvement.
Assures documentation is compliant with federal and state regulations, coding guidelines and hospital policies.
Remains up-to-date in clinical and coding/documentation-related materials, including CDS best practices as defined by ACDIS as well as ICD-10-CM/PCS, AHA Coding Clinic guidelines for coding and reporting and MS-DRG/APR-DRG classification systems.
Monitors regulatory and reimbursement changes.
Serves as resource for CDI informational needs and updates CDI on coding changes, medical science and CDI practice standards.
Provides guidance, support and expertise to the CDI specialists
Track trends in documentation concerns and implementing solutions for improvement.
Uses leadership and critical thinking skills to identify opportunities for team processes and engagement
Recommend solutions for improvement when deficiencies are identified.
Provides CDI specialists, coders, and coding validation specialists with clinical feedback to assist in accurately capture diagnoses and/or opportunities for querying physicians post discharge for additional information.
Evaluates the success of concurrent documentation improvement on an ongoing basis.
Advances professional growth and development through participation in educational programs and workshops and maintaining knowledge of industry standards and practices.
Assists manager, when requested, in the development of APR/DRG/query response physician reports. Maintains complete confidentiality of patient information in addition to hospital and individual physician practice pattern data.
Assumes operational oversight of CDI department in the absence of the CDI manager.
Adheres to all BMC's RESPECT behavioral standards.
Other duties as assigned.
(The above statements in this job description are intended to depict the general nature and level of work assigned to the employee(s) in this job. The above is not intended to represent an exhaustive list of accountable duties and responsibilities required).
JOB REQUIREMENTS
REQUIRED EDUCATION AND EXPERIENCE:
Bachelor's degree (or equivalent) in nursing, health information management or related field and at least five years (5) years experience in clinical documentation, or equivalent combination of education and experience, required.
PREFERRED EDUCATION AND EXPERIENCE:
Master's degree
CERTIFICATES, LICENSES, REGISTRATIONS REQUIRED:
Licensed RN
CERTIFICATES, LICENSES, REGISTRATIONS PREFERRED:
CCDS, CDIP
KNOWLEDGE, SKILLS & ABILITIES (KSAs):
Demonstrate advanced knowledge of clinical documentation integrity practices, policies, workflows, and analysis.
Critical thinking, analytical and problem solving skills
Highly organized with strong project/task management skills
Knowledge of federal, state and payer specific regulations, policies and guidelines pertaining to coding (inpatient or outpatient), documentation requirements and billing
Experience with 3M Encoder/Grouper, SMART software preferred
Knowledge of care delivery documentation systems and related medical record documents.
Knowledge of age-specific needs and the elements of disease processes and related procedures.
Strong broad-based clinical knowledge and understanding of pathology/physiology of disease processes.
Excellent written and verbal communication skills.
Excellent critical thinking skills.
Demonstrated employee and medical staff relationships in the past and has the ability to maintain those going forward.
Working knowledge of inpatient admission criteria.
Ability to work independently in a time-oriented environment.
Computer literacy and familiarity with the operation of basic office equipment.
Assertive personality traits to facilitate ongoing physician communication.
Ability to be adapt to changes in the workload, to work independently and effectively prioritize work assignments
Working knowledge of Medicare reimbursement system and coding structures preferred, but not required.
Familiarity with physician practices, health information, case management or related healthcare discipline
Familiarity with all government health care reimbursement systems
Have experience working collaboratively with diverse groups in a health care environment
Demonstrated success in interacting effectively with physicians
Excellent speaking, writing and teaching skills
Proficient with standard Microsoft programs (i.e. MS Word, Excel, PowerPoint, Outlook) and web browsers.
Ability to analyze large amounts of data to identify trends.
Ability to provide direction and development to employees by coaching, identifying training needs, assigning progressively challenging projects, and assisting in career development planning.
Compensation Range:
$83,000.00- $120,500.00
This range offers an estimate based on the minimum job qualifications. However, our approach to determining base pay is comprehensive, and a broad range of factors is considered when making an offer. This includes education, experience, skills, and certifications/licensures as they directly relate to position requirements; as well as business/organizational needs, internal equity, and market-competitiveness. In addition, BMCHS offers generous total compensation that includes, but is not limited to, benefits (medical, dental, vision, pharmacy), discretionary annual bonuses and merit increases, Flexible Spending Accounts, 403(b) savings matches, paid time off, career advancement opportunities, and resources to support employee and family well-being.
NOTE: This range is based on Boston-area data, and is subject to modification based on geographic location.
Equal Opportunity Employer/Disabled/Veterans
According to the FTC, there has been a rise in employment offer scams. Our current job openings are listed on our website and applications are received only through our website. We do not ask or require downloads of any applications, or “apps” job offers are not extended over text messages or social media platforms. We do not ask individuals to purchase equipment for or prior to employment.
$83k-120.5k yearly Auto-Apply 32d ago
Silicon Validation Engineer 4
Latticesemi
Remote equipment validation engineer job
Lattice Overview There is energy here…energy you can feel crackling at any of our international locations. It's an energy generated by enthusiasm for our work, for our teams, for our results, and for our customers. Lattice is a worldwide community of engineers, designers, and manufacturing operations specialists in partnership with world-class sales, marketing, and support teams, who are developing programmable logic solutions that are changing the industry. Our focus is on R&D, product innovation, and customer service, and to that focus, we bring total commitment and a keenly sharp competitive personality.Energy feeds on energy. If you flourish in a fast paced, results-oriented environment, if you want to achieve individual success within a “team first” organization, and if you believe you can contribute and succeed in a demanding yet collegial atmosphere, then Lattice may well be just what you're looking for. Responsibilities & Skills
What Will You Get to Do?
Do you have a passion for invention and self-challenge? This position gives you an opportunity to learn and participate in one of the most cutting-edge projects that Lattice's Silicon Engineering team has embarked upon to date.
We are validating building blocks in FPGA on board level to ensure functionality and performance aspect of Design intent. FPGA consists of various IPs as a building block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, Fabric, I/O etc.
As a Silicon Design Validationengineer, you will have an opportunity to learn and train yourself on how to validate one/or many of the building blocks within the FPGA. And also, you will be able to acquire knowledge on process/methodology required for validating certain IPs from planning to completion. While you are working on those, you will be exposed to cutting edge equipment and advanced boards as well as Various SW/tools/scripts.
What you're going to be exposed to and learn:
The ideal candidate is highly motivated in developing a career in Silicon Design Validationengineering. You will get significant exposure and training in the following areas:
Chance to learn FPGA and it's build block such as SERDES(PMA/PCS), Memory DDR(DDR4, LPDDR4, DDR5 etc), DPHY, PLL, DSP, MIPI, Fabric, I/O etc but not limited.
Validate and characterize various IPs from silicon arrival to release to production.
Develop validation and characterization plans for certain IP, bench hardware and software.
Develop test logic RTL to achieve intended validation/characterization test.
Drive new silicon product bring-up, validation, debug to asses IP functionality/performance. Characterizing data sheet parameters. Analyzing the measured data with statistical view. Data sheet preparation etc.
Serve as the central resource with design, verification, manufacturing, test, quality and marketing/apps as the product(s) move Silicon arrival to product release.
Supporting customer issues as required to resolve issues found after product release
You Have…
8+ years of experience
Electrical Engineering degree with a strong desire to pursue an engineering career in Silicon Design Validation
Capability to lead small group of teams as tech lead.
Expertise in High Speed Serdes Interface characterization and protocol compliance testing such as PCIe/Ethernet/SDI/CoaXpress/JESD204, MIPI D-PHY, MIPI CSI/DSI-2, USB and DisplayPort/HDMI etc.
Expertise in high speed board design and signal integrity evaluation/debug.
Expertise in Verilog/VHDL and design implementation using FPGA development tools.
Expertise in test automation development using programming languages such as Python, Perl.
Knowledge of statistical analysis concepts and use of analysis tools such as JMP, R.
Proficiency with bench equipment for device characterization such as BERT, VNA, Oscilloscopes, Protocol Exerciser/Analyzers.
Exposure on FPGA(emulation/prototyping etc)
Strong written and verbal communication skills to work with cross-functional team
Self-motivated and proactive with critical thinking.
Good problem solving and debugging skills.
Benefits
Benefits:
The base pay for this role is between $144,000 to $180,000 per year. In addition to base salary, we offer an incentive plan bonus, and new hire equity for a competitive total compensation package.
Lattice recognizes that employees are its greatest asset and the driving force behind success in a highly competitive, global industry. Lattice continually strives to provide a comprehensive compensation and benefits program to attract, retain, motivate, reward and celebrate the highest caliber employees in the industry.
Lattice is an international, service-driven developer of innovative low cost, low power programmable design solutions. Our global workforce, some 800 strong, shares a total commitment to customer success and an unbending will to win. For more information about how our FPGA, CPLD and programmable power management devices help our customers unlock their innovation, visit ******************** You can also follow us via Twitter, Facebook, or RSS. At Lattice, we value the diversity of individuals, ideas, perspectives, insights and values, and what they bring to the workplace. Applications are welcome from all qualified candidates.
Lattice
Feel the energy.
$144k-180k yearly Auto-Apply 20h ago
FMS Verification & Validation Engineer- Aerospace Industry
DBSI Services 3.5
Remote equipment validation engineer job
Benefits:
401(k)
401(k) matching
FMS Verification & ValidationEngineer Only USC/ GC About the Role: We are seeking a skilled Verification Engineer with expertise in Flight Management Systems (FMS).
The ideal candidate will have experience in verification and validation (V&V) processes for avionics systems, with a strong background in display, navigation, and application systems within FMS.
Skill Matrix:
· Yrs. In Flight Management Systems
· Yrs. In verification and validation
· Yrs. In Display, GPS/Navigation systems
· Yrs. In DO-178C
· Yrs. In SSIT and HSIT level testing
· Yrs. In Aerospace
· Yrs. In DOORs or JAMA
· Yrs. In Flight Deck Avionics Systems.
Qualifications You Must Have
· Must possess at least a bachelor's degree or its equivalent in Aerospace Engineering, Systems Engineering, Electrical Engineering, Computer Engineering, Software Engineering, Industrial Engineering or a related field and at least five years of progressive experience as a Software Engineer or related role in the avionics industry. In the alternative, at least a master's degree or its equivalent in Aerospace Engineering, Systems Engineering, Electrical Engineering, Computer Engineering, Software Engineering, Industrial Engineering or a related field and at least three years of experience as a Software Engineer or related role in the avionics industry would be acceptable.
· Must possess at least 3 years of experience with development, verification, and certification of Real time embedded Software and/or Flight Deck Avionics Systems.
· Must possess at least 3 years of experience with capturing requirements in a requirements management tool, such as DOORs or JAMA.
· Must possess at least 3 years of experience with following processes and standards related to the development of software (such as DO-178).
· Must possess at least 3 years of experience working closely with multi-disciplinary engineering teams.
What You will do
· Conduct and coordinate moderately complex tests for control and diagnostic systems that contain logical and mathematical solutions.
· Conduct multidisciplinary research in assisting equipment designers in the planning, design, development, and utilization of electronic data processing systems for product and commercial software to develop software engineering activities.
· Analyze system capabilities and determines end user needs to resolve problems on program intent, output requirements and input data acquisition to ensure current and future needs of the business are met.
· Ensure hardware and software standards are met.
· Design and implement build procedures that are used to support hardware and software product development and use.
· Develop software configuration standards for company-wide use.
This is a remote position.
Compensation: $110,000.00 - $120,000.00 per year
MAKING THE INDUSTRY'S BEST MATCHES DBSI Services is widely recognized as one of the industry's fastest growing staffing agencies. Thanks to our longstanding experience in various industries, we have the capacity to build meaningful, long-lasting relationships with all our clients. Our success is a result of our commitment to the best people, the best solutions and the best results.
Our Story:
Founded in 1995
Privately Owned Corporation
Managing Partner Business Model
Headquartered in New Jersey
US Based Engineers Only
Collaborative Team Approach
Methodology and Process Driven
GET HIRED Top performing engineers are the foundation of our business. Our priority is building strong
relationships with each employment candidate we work with. You can trust our professional
recruiters to invest the time required to fully understand your skills, explore your professional
goals and help you find the right career opportunities.
$110k-120k yearly Auto-Apply 60d+ ago
Sr. Navy Qualified Validator ( NQV) Philadelphia, PA
Watershed Security
Remote equipment validation engineer job
JOB DESCRIPTION Watershed Security, is a Veteran Owned Small Business with over 20 years' Cybersecurity and Government Contracting experiencing. Watershed is looking for a Senior Navy Qualified Validator (NQV) to support the Naval Surface Warfare Center (NSWC) in Philadelphia, PA. The successful candidates will be responsible for reviewing and implementing Risk Management Framework (RMF) lifecycle documentation, ensuring the confidentiality, integrity, and availability (CIA) of systems, networks, and information. This position involves conducting risk and vulnerability assessments, ensuring proper accreditation procedures are followed, and documenting any non-compliance issues.
REQUIRED QUALIFICATIONS
Bachelor's degree in computer science, information technology, communications systems management, or an equivalent science, technology, engineering & mathematics (STEM) degree from an accredited college or university.
Active Navy Qualified Validator Certification.
Must have at least one of the following active certifications: CCNA Security, CySA+, GICPS, GSEC, Security+, CND, SSCP.
Years of Experience: Ten (10) years' practical experience in a cybersecurity or A&A related field.
Implementing and/or reviewing RMF lifecycle documentation
Validating confidentiality, integrity, and availability of systems
Conducting risk and vulnerability assessments
Ensuring proper accreditation procedures are followed
Documenting non-compliance issues
Clearance Level: SECRET; US Citizen.
Ability to possibly provide onsite support in Philadelphia PA. Some/all remote work may be an option, however the norm will be onsite support. This will be dependent upon customer needs and classification level of work being performed.
Some travel may be required.
Experience with the Navy RMF Process Guide (RPG), and Navy A&A tools such as ACAS, eMASS and eMASSter.
Proficient with Microsoft Office Suite (Word, Excel, Teams, Project). Self Starter; detail oriented; able to brief senior level staff.
DESIRED QUALIFICATIONS
Validation of 10 or more Navy Packages
Experience with the NAVSEA RMF Business Rules
Contingent upon award
PAY RANGE
Final salary is influenced by factors such as location, contract labor categories, experience, skills, education, and certifications. Watershed offers competitive compensation, medical and dental benefits, educational reimbursement, 401K plans with matching, 15 days of PTO to start and 11 paid holidays per year. The proposed salary range for this position is: $100,000 - $130,000 USD.
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
Powered by JazzHR
h7KJOo4Y9h
$100k-130k yearly 21d ago
Validation Specialist
GDIT
Remote equipment validation engineer job
Type of Requisition:
Regular
Clearance Level Must Currently Possess:
None
Clearance Level Must Be Able to Obtain:
None
Public Trust/Other Required:
Other
Job Family:
Ancillary Health
Job Qualifications:
Skills:
Decision Making, Medical Record Abstraction, Microsoft Office, Time Management, Written Communication
Certifications:
None
Experience:
3 + years of related experience
US Citizenship Required:
No
Job Description:
Validation Specialist
Drive better health outcomes for our clients as a Validation Specialist at GDIT. Here, your work will impact many as you deliver healthcare expertise and services where they are needed most. Own this opportunity to advance not just the state of public healthcare and patient outcomes, but also your personal career growth.
At GDIT, people are our differentiator. As a Validation Specialist you will help ensure today is safe and tomorrow is smarter. Our work depends on Validation Specialists joining our team to perform adjudications of hospital-reported data from acute-care inpatient and observation/outpatient admissions in accordance with contractual and organizational guidelines.
HOW A VALIDATION SPECIALIST MAKES AN IMPACT:
Investigate and adjudicate discrepancies between hospital and CDAC abstractions to determine the most accurate answer according to guidelines provided by the customer.
Formulate well-written feedback comments that serve to educate and explain the supportive rationale behind the adjudications for external and internal stakeholders.
Collaborate with Training, Quality, and Management to improve CDAC accuracy and efficiency.
Perform medical record abstractions as needed in support of CDAC production goals and customer deadlines.
Accurately enter data into the Provider Validation Tool (PVT), HAI, and QSRS abstraction/validation software.
WHAT YOU'LL NEED TO SUCCEED:
Education: High School Diploma/GED.
Required Experience: 3+ years of related medical record and/or clinical experience. 2+ years of CDAC abstraction experience during which the individual achieved above average accuracy and productivity.
Required Technical Skills: Reliable home internet and proficiency with Microsoft Office tools (Outlook, Word, Excel, and Teams).
Required Skills and Abilities: Verbal and Written Communication, Decision Making, Time Management, Flexibility, Self-Motivation, Adaptability, Teamwork, Confidentiality.
Preferred Skills: Innovation, Curiosity, Proactiveness, Problem-solving, Resourceful.
Location: Primarily remote, but option to work at York, PA customer site is also available.
GDIT IS YOUR PLACE:
Full-flex work week to own your priorities at work and home.
401K with company match.
Comprehensive health and wellness packages.
Internal mobility team dedicated to helping you own your career.
Professional growth opportunities including paid education and certifications.
Cutting-edge technology you can learn from.
Rest and recharge with paid vacation and holiday time.
#GDITHealth
#GDITFedHealthJobs
The likely hourly rate for this position is between $23.30 - $27.38. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.
Scheduled Weekly Hours:
40
Travel Required:
None
Telecommuting Options:
Remote
Work Location:
Any Location / Remote
Additional Work Locations:
Total Rewards at GDIT:
Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. GDIT typically provides new employees with 15 days of paid leave per calendar year to be used for vacations, personal business, and illness and an additional 10 paid holidays per year. Paid leave and paid holidays are prorated based on the employee's date of hire. The GDIT Paid Family Leave program provides a total of up to 160 hours of paid leave in a rolling 12 month period for eligible employees. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.Join our Talent Community to stay up to date on our career opportunities and events at
gdit.com/tc.
Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans
$23.3-27.4 hourly Auto-Apply 4d ago
Engineer II, Validation
Moderna Theraputics
Remote equipment validation engineer job
The Role In this role, you will perform the duties according to the Moderna Commissioning, Qualification and Validation (CQV) program and execute assigned qualification activities. This role will own the delivery of the capital projects, site re-qualification and periodic review programs, ensuring systems and equipment remain in an operational state of compliance.
Here's What You'll Do
* Perform commissioning, qualification, and validation activities for Moderna's GMP manufacturing facility which includes raw material, Drug Substance, Formulation, Drug Product, Finished Goods, and personalized medicine capabilities.
* Working with external validation service providers. Responsibilities and ensure commitment to key stakeholders are met.
* Ensure the validated status of site facilities, utilities, equipment, and processes is established and maintained in accordance with internal procedures, regulatory requirements, and industry guidance / standards.
* Support new equipment qualification activities for capital and operational projects.
* Assist investigation and reviews deviation investigations related to manufacturing process equipment, utilities, automation, computer systems, validation, and laboratory instruments.
* Provide support for equipment and systems in use at Moderna facilities (Controlled Temperature Units [Refrigerators, Freezer, Incubators], Analytical Instruments [used for in-process and quality control testing], Manufacturing Unit Operations [Ultrafiltration, Chromatography, Mixers, Tanks / Vessels, Bioreactors / Fermenters], etc.).
* Support internal and external audits/inspections as a part of Commissioning, Qualification and Validation program.
* Participate in continuous quality system improvements and supports implementing improvements in the GMP Validation and Change Control Programs.
* Drive results by owning and completing validation initiatives / projects against identified timelines.
* Own quality records such as Change Controls, Deviations, Corrective / Preventative Actions (CAPAs), and continuous improvement initiatives related to validation activities.
* Additional duties as may be assigned from time to time
Here's What You'll Need (Basic Qualifications)
* B.S. in Life Science or Engineering Degree (Mechanical, Computer Science or Biomedical Engineering Etc.). Master's degree in above discipline preferred.
* Minimum of 2+ years in commissioning / qualification / validation /quality experience in cGMP manufacturing environments
* Here's What You'll Bring to the Table (Preferred Qualifications)
* Strong understanding of validation principles including but not limited to facilities, utilities, equipment, and systems (FUSE).
* Excellent technical documentation generation and review skills ensuring the content is technically sound, adheres to applicable site procedures and is suitable for regulatory submission / inspection.
* Must be able use his / her technical background to investigate issues using a structured problem-solving approach to determine true root cause and develop effective corrective and preventative actions. Must be able to be able to find true root cause and path forward for complex problems.
* Excellent interpersonal and communication skills (verbal and written) are required. Expected to be able to present own work to peers and cross-functional managers and influence leadership decisions. Technical writing skills required.
* Ability to interact well with other groups and must be able to take ownership of and follow through on assignments. Must be able to drive results on multiple complex assignments simultaneously with minimal required direction from his / her manager.
* Ability to represent Moderna's interests, objectives, and policies in a professional and responsible manner.
* A desire to make an impact as part of a high-growth, transformational company that is Bold, Relentless, Curious, and Collaborative.
* At Moderna, we are focused on delivering on our mission by enabling talent to thrive. For this role, we are currently unable to offer immigration sponsorship. Candidates must already hold work authorization in US and be able to maintain that status without the need for future sponsorship.
Pay & Benefits
At Moderna, we believe that when you feel your best, you can do your best work. That's why our US benefits and global well-being resources are designed to support you-at work, at home, and everywhere in between.
* Best-in-class healthcare coverage, plus voluntary benefit programs to support your unique needs
* A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
* Family planning benefits, including fertility, adoption, and surrogacy support
* Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown
* Savings and investment opportunities to help you plan for the future
* Location-specific perks and extras
The salary range for this role is $72,500.00 - $116,000.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual's position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.
The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.
About Moderna
Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.
By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.
We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.
If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.
Our Working Model
As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.
Moderna is a smoke-free, alcohol-free, and drug-free work environment.
Equal Opportunities
Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law. Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!
Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.
Accommodations
We're focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.
Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at leavesandaccommodations@modernatx.com.
Export Control Notice
This position may involve access to technology or data that is subject to U.S. export control laws, including the Export Administration Regulations (EAR). As such, employment is contingent upon the applicant's ability to access export-controlled information in accordance with U.S. law. Due to the nature of the work and regulatory requirements, only individuals who qualify as U.S. persons (citizens, permanent residents, asylees, or refugees) are eligible for this position. For this role Moderna is unable to sponsor non-U.S. persons to apply for an export control license.
#LI-NB1
*
$72.5k-116k yearly Auto-Apply 60d+ ago
ADAS Feature Verification and Validation Engineer
Ford Motor 4.7
Remote equipment validation engineer job
...
Advanced Driver Assistance Systems (ADAS) Verification & Validation Application Engineer and focuses on ensuring the feature delivers the expectations of the customer. You will develop and implement feature requirements and specifications (including functional safety) for features like adaptive cruise control, automatic emergency braking, cross traffic alert, pro trailer features, advanced lighting, and 360 camera systems at a system and sub-system level and validate them according to the systems engineering model. As an Application Engineer, you will collaborate with research engineers, user experience teams, designers, hardware and software developers to define, develop, and verify the customer-facing attributes and performance capabilities of ADAS features. You will also develop new verification methods and work with vehicle, hardware-in-the-loop, model-in-the-loop and other advanced testing methodologies to validate your feature.
You'll have...
• B.S. in Electrical Engineering, Mechanical Engineering, or related technical field
Experience preferably in developing features in the Driver Assistance domain using radars, cameras, lidars, ultrasonic sensors and other related vehicle systems (body, electrical, chassis, powertrain)
Familiarity with actuators and control systems
Even better, you may have...
Masters in Engineering (Electrical, Mechanical, Aerospace, Mechatronics, Software, Computer Science, AI, Systems Engineering, Product Development) or related technical field
Experience applying Systems Engineering principles
Experience with robotic verification and testing methods
Troubleshooting experience with electromechanical systems
Experience with differential GPS equipment
Experience using typical automotive interfaces: CAN, CANFD, Autosar, Auto-Ethernet, etc.
Experience using Vector CANape, CANalyzer and dSPACE Controls Desk or similar tools
Experience with Matlab/Simulink
Experience in verification techniques (design verification methods, vehicle data acquisition/analysis)
Experience with virtual validation methods (HIL/MIL/SIL)
Strong leadership skills, passion for quality, passion to improve customer satisfaction
Good communications and project management skills
Strong oral & written skills
Ability to work both independently and take initiative when necessary
Strong teamwork & interpersonal skills
You may not check every box, or your experience may look a little different from what we've outlined, but if you think you can bring value to Ford Motor Company, we encourage you to apply!
As an established global company, we offer the benefit of choice. You can choose what your Ford future will look like: will your story span the globe, or keep you close to home? Will your career be a deep dive into what you love, or a series of new teams and new skills? Will you be a leader, a changemaker, a technical expert, a culture builder…or all of the above? No matter what you choose, we offer a work life that works for you, including:
• Immediate medical, dental, vision and prescription drug coverage
• Flexible family care days, paid parental leave, new parent ramp-up programs, subsidized back-up child care and more
• Family building benefits including adoption and surrogacy expense reimbursement, fertility treatments, and more
• Vehicle discount program for employees and family members and management leases
• Tuition assistance
• Established and active employee resource groups
• Paid time off for individual and team community service
• A generous schedule of paid holidays, including the week between Christmas and New Year's Day
• Paid time off and the option to purchase additional vacation time.
This position is a range of salary grades 6-8 .
For more information on salary and benefits, click here: *****************************
Visa sponsorship is not available for this position.
Candidates for positions with Ford Motor Company must be legally authorized to work in the United States. Verification of employment eligibility will be required at the time of hire.
Onsite work of up to four days per week will be required for candidates within commuting distance of a Ford hub location.
#LI-Hybrid
#LI-CL2
What you'll do...
Define and document the vehicle-level acceptance criteria for ADAS features
Lead / support the development of verification plans and verification methods
Collaborate with global functional partners to meet system and vehicle level performance requirements
Cascade system-level requirements to functional partners
Lead/support the development and sign-off of ADAS features on vehicle programs
Support feature calibration studies to satisfy vehicle-level performance requirements
Develop MATLAB and CAN tools for data collection and analysis
Identify opportunities to utilize HiL and CAE methods for feature calibration and performance verification
Plan and execute real-world evaluations of ADAS features via vehicle/HIL/virtual testing and identify system problems and issues
Support and coordinate root-cause analysis with internal functions and external suppliers to ensure delivered system achieves feature requirements
Benchmark competitors and monitor public domain requirements
$79k-102k yearly est. Auto-Apply 32d ago
Process & Validation Engineer (100% Travel)
Syner-G Biopharma Group
Remote equipment validation engineer job
:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit ***********************
(Syner-G is seeking both Process and ValidationEngineering Candidates)
PROCESS ENGINEER POSITION OVERVIEW :
Syner-G is seeking an experienced Process Engineer to assist with, but not limited to, process engineering, process development, materials & engineering sciences, technology transfer, facilities/utilities/technical services, and manufacturing processes. We are accepting applicants who will be able to travel remotely throughout to client sites in the United States.
WORK LOCATION:
Travel to client sites will be required up to 100%, based on project demands and client expectations.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented and changed as necessary.)
Assist with the requirements specifications, design, functional requirements, development, commissioning, and qualification of process equipment or systems for compliance with manufacturing requirements and facility fit.
Lead start-up activities, including commissioning and qualification of facilities, utilities, and equipment (FUE).
Assist with risk assessments, feasibility reviews, risk mitigations, and testing of process materials to ensure compliance with manufacturing requirements.
Assist with the requirements specifications, design & development of process parameters, and the commissioning/validation of manufacturing processes for compliance with quality and regulatory requirements.
Provide technical support for the product/process lifecycle and related activities.
Support client requirements to lead or help process or engineering projects at vendors or other third-party contract companies, as needed.
Provide support for improvement projects regarding processes and systems.
Support or provide risk assessment and mitigation activities for process development, manufacturing, and testing as applicable.
Provide technical support for scale-up activities from development to manufacturing, including but not limited to technology transfers and facilities improvements (e.g., utilities/equipment integration).
Analyze and recommend improved technology to increase quality and efficiency.
Provide technical analysis and support for new or improved process systems.
Facilitate and schedule meetings with subject matter experts across the organization.
Ensure compliance with cGMP, regulatory, and industry standards.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Education
:
Bachelor's degree in Engineering, Bio/Pharma Science, or a related technical field of study.
Technical Experience
:
4-7 years of related engineering and/or technical experience required.
Experience with cGMP Manufacturing within an FDA-regulated manufacturing company.
Knowledge of cGxP Quality Systems within an FDA-regulated manufacturing company.
Knowledge of FDA regulations and guidance or applicable regulatory standards and practices.
Proficient with MS Office suite, MS Project, Visio, and related electronic formats required to perform the respective job at a client.
Knowledge of laboratory and manufacturing systems such as LIMS, MES, etc.
Experience with Process Engineering, Manufacturing Engineering, MSAT, Commissioning, CQV, and Tech Transfer.
Experience with Fillers, Wave Bioreactor, Cell Processing Systems, Scales, Pumps, Welder/Sealers, and Flow Cytometers.
Knowledge, Skills, and Abilities
:
Excellent computer, verbal, and written communication skills.
Innovative problem-solving skills and an integrated view of business/scientific issues.
Accountable and responsible individual to perform as intended for clients.
Willingness to travel to various clients when needed, with acceptable limitations during noted health pandemics or related constraints.
ESSENTIAL FUNCTIONS:
Physical Demands
:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment
:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
--
VALIDATIONENGINEER POSITION OVERVIEW:
We are seeking a ValidationEngineer to assist with the development and execution of validation protocols for various types of processes. The ValidationEngineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.
WORK LOCATION:
Travel to client sites may be required up to 100%, based on project demands and client expectations.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented and changed as necessary.)
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.
Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
Support the resolution of regulatory observations or manufacturing site issues.
Execute periodic reviews and requalification for temperature chambers.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Education
:
Bachelor's degree in a related life science field.
Technical Experience
:
4-7 years of experience within the biotech, pharmaceutical, or medical device industry.
Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.
Validation expertise in Equipment, CSV, Method, and Process.
Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
Report writing experience for IQ, OQ, PQ, and CSV.
Knowledge, Skills, and Abilities
:
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
Applicants must have current work authorization when accepting a position at Syner-G. Currently, Syner-G is unable to sponsor or take over sponsorship of an employment Visa at this time.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
$71k-94k yearly est. Auto-Apply 4d ago
Cleaning Validation Engineer (Remote)
Mindful Quality 4.2
Remote equipment validation engineer job
Mindful Quality is a growing consulting firm in the Biotechnology and Pharmaceutical industries. Mindful Quality specializes in cleaning validation, process development, project management, and regulatory guidance related to manufacturing quality assurance.
The Cleaning ValidationEngineer is responsible for cleaning process engineering and validation for our clients. The position will involve supporting cleaning cycle development, cleaning validation, and continuous cleaning monitoring in cGMP facilities. Ideal candidate has experience in cleaning validation including CIP, COP, and manual cleaning.
The Role
Assess client's cleaning validation documents to identify regulatory concerns including potential corrective actions in alignment with industry best practices.
Troubleshoot cleaning failures, develop, and optimize cleaning processes.
Write, revise, and review cleaning related documents including Master Plans, Project Plans, Batch Records, Standard Operating Procedures, Forms, Protocol, Summary Reports, Forms, Risk Assessments, etc.
Interact with team members and clients to create, review, and approve documentation per timeline.
Plan and track project deliverables. This includes coordination with internal and external team members.
Create, develop, edit, and maintain high-quality documentation following internal and client style guidelines, document standards, and templates, while ensuring that quality targets, timelines, and regulatory requirements are met.
Create, manage, and help close out protocol exceptions and deviations
Manage protocol execution paperwork as needed to support clients.
Create and manage Change Control and CAPA documentation
Look for ways to continuously improve generated documentation
Communicate effectively with team members and external vendors/clients
Develop training materials for manufacturing staff based on SOPs authored.
Mentor and train client staff on cleaning validation principles
Other duties as assigned by manager
The Candidate
Degree in Chemistry, Biochemistry, Pharmacy, Engineering, or other related fields
5+ years' experience in cleaning validation within a regulated manufacturing environment. Preferrable Pharmaceutical or Biotechnology industry.
Working knowledge of GMPs - Preferred
Hands-on experience with the following systems: CIP systems, parts washers, manual cleaning is required.
Experience with rinse and swab sampling techniques
Proven ability to review, interpret and make scientific conclusions and recommendations based on data
Ability to understand and extract necessary information from technical documents
2-5 years of technical writing experience
Excellent grammar and writing skills - Required
Effectively work within a team environment and interface with peers, management, etc.
Ability to work independently, handle multiple tasks simultaneously and to meet critical milestones and goals. - Required
Able to effectively manage workload and prioritize activities
Proficient computer skills
Advanced knowledge of Microsoft Word/Excel/PowerPoint - Required
Must be willing to travel to client sites worldwide to support work as needed.
$67k-91k yearly est. 60d+ ago
Validation Engineer
Syner-G
Remote equipment validation engineer job
Job Description
:
A career here is life-enhancing.
At Syner-G, we enable our people to build careers that impact positively on their quality of life. Through our expertise, insight, consulting and management skills, we accelerate breakthrough science and delivery of life-enhancing therapies to more patients. We work across a diverse range of clients and projects, supporting many organizations from the most critical phases of the drug discovery and approval process through to commercialization. It is meaningful, varied and thought-provoking work with a strategic emphasis, a solutions-driven approach and significant, real-world outcomes, from science to delivery/success.
Underpinning this mission is a culture that aligns perfectly with what we want to achieve. We enable our people to grow, we support them in their learning and we reward them in so many different ways. In return, they play an instrumental role in maintaining our reputation across the globe as a strategic biopharma product development and delivery partner.
Syner-G was recently honored with BioSpace's prestigious "Best Places to Work" 2026 award, for the third consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation.
At Syner-G, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact.
For more information, visit ***********************
POSITION OVERVIEW:
Syner-G is seeking a ValidationEngineer to assist with the development and execution of validation protocols for various types of processes. The ValidationEngineer will be responsible for driving overall quality performance and compliance throughout the organization by defining, implementing, and maintaining the validation program.
KEY RESPONSIBILITIES:
(This list is not exhaustive and may be supplemented and changed as necessary.)
Generate and execute life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, shipping, facilities, utilities, systems, equipment, and processes for (re)qualification/(re)verification.
Support validation activities for Basecamp and client Tech Transfer projects, including generation, execution, review, and closure of validation life cycle documents (RA, VP, IQ, OQ, PQ, TM, VR).
Write, review, and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including any or all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation, engineering design, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), verification protocols, and/or commissioning test procedures.
Write reports to summarize validation/verification/commissioning and/or revalidation/verification/commissioning activities.
Write procedures, investigations, protocols, reports, change controls, etc., to support the Maintenance and Engineering departments.
Perform P&ID Walkdowns. Perform Thermal mapping of temperature-controlled chambers, warehouses, and SIP processes.
Support the resolution of regulatory observations or manufacturing site issues.
Execute periodic reviews and requalification for temperature chambers.
QUALIFICATIONS AND REQUIREMENTS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
Education
:
Bachelor's degree in a related life science field.
Technical Experience
:
4-7 years of experience within the biotech, pharmaceutical, or medical device industry.
Knowledge and experience working with FDA cGMP, FMEA, and Risk Analysis required.
Validation expertise in Equipment, CSV, Method, and Process.
Protocol generation experience of automated production systems, with a concentration on computerized equipment and systems validation.
Report writing experience for IQ, OQ, PQ, and CSV.
Knowledge, Skills, and Abilities
:
Strong verbal and written communication skills and the ability to discuss technical topics with non-technical people is strongly desired.
ESSENTIAL FUNCTIONS:
Physical Demands
:
The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit, as well as to lift and carry objects such as books and files weighing up to 25 pounds. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.
Work Environment
:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.
TOTAL REWARDS PROGRAM:
We define total rewards as compensation, benefits, remote work/flexibility, development, recognition, and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work "almost anywhere". However, if a physical work location is more for you, we have office locations in Greater Boston; San Diego, CA; Boulder, CO; and India.
LEGAL STATEMENT:
Syner-G is proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee's race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G is an E-Verify employer.
$72k-95k yearly est. 13d ago
Validation Engineer
PSC Biotech 3.9
Equipment validation engineer job in Columbus, OH
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients' success, and you can be a part of our team's achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.
The Experience
With operations spanning the globe and featuring a multi -cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.
We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.
At PSC Biotech , it's about more than just a job-it's about your career and your future.
Your Role
We are hiring experienced validationengineers responsible for the commissioning, qualification, and validation for pharmaceutical facilities, utilities, and equipment. Our engineers play a critical role in driving project success, while supporting validation planning, development, documentation, and execution, and ensuring regulatory standards and quality requirements are met.
Develop and execute commissioning, qualification, and validation protocols for required equipment and systems.
Prepare and maintain comprehensive documentation, including validation protocols, plans, reports, and standard operating procedures.
Identify and assess risks associated with CQV activities and develop mitigation strategies.
Troubleshoot and resolve issues related to equipment and process performance.
Collaborate with cross -functional teams to ensure alignment on CQV activities and project timelines.
Ensure compliance with regulatory requirements (FDA, EMA, etc.) and industry standards (GMP, GAMP, etc.).
Additional responsibilities as required to drive successful validation project deliverables.
Requirements
Bachelor's degree in Engineering, Life Sciences, or a related field.
Proven experience in equipment/facility/systems commissioning, qualification, and validationengineering in the pharmaceutical and/or biotech industries.
Strong knowledge of regulatory requirements and industry standards.
Experience with validation lifecycle management and risk -based approaches.
Excellent analytical and technical problem solving skills.
Strong technical writing skills and understanding of full lifecycle documentation (protocols, reports, procedures, risk assessments, specifications and requirements, etc.)
Effective communication and interpersonal skills.
Proactive with strong organization, time management, and project management abilities.
Excellent attention to detail with commitment to quality and compliance.
Travel is required. At PSC Biotech, many of our projects and clients are located in various regions around the country. Therefore, we value candidates who are willing and able to travel as needed for project assignments and client engagements. The ability to adapt to different locations, cultures, and work environments is essential, as it allows our team members to collaborate effectively with clients and colleagues nationally.
Must be authorized to work in the US.
No C2C at this time.
BenefitsOffering a full suite of benefits, PSC Biotech⢠is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.
Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
401(k) and 401(k) matching
PTO, Sick Time, and Paid Holidays
Education Assistance
Pet Insurance
Discounted rate at Anytime Fitness
Financial Perks and Discounts
Equal Opportunity Employment Statement
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer -sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant's, employee's, or intern's actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.
#LI -TP1
$69k-87k yearly est. 60d+ ago
Validation Engineer
Cai 4.8
Equipment validation engineer job in Columbus, OH
Are You Ready?CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.
Our Purpose We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
Our Foundational Principles- At CAI, we are committed to living our values-both professionally and personally:- We act with integrity- We serve each other- We serve society- We work for our future- We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it
will
be done, not how it
used
to be done.
Key Responsibilities1. Technical Responsibilities- Develop documentation for CQV activities- Write and execute protocols (field verification)- Develop summary reports at client sites2. Areas of Focus- Pharmaceutical facilities- Utilities- Equipment3. Project & Team Management- Plan and coordinate work- Direct small teams in document development and/or execution
Qualifications and Experience- Bachelor's degree in a science or engineering field (or equivalent experience)- 2-4 years' experience in commissioning and qualification in a regulated industry- Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus- Preferred experience in:- Facilities and equipment startup- Walk-downs and troubleshooting- Utilities (WFI, RO, HVAC)- Upstream/downstream processing- Purification, recovery- Building automation- Pharmaceutical manufacturing processes
Critical CompetenciesInfluence Strategy- Pursues initiatives aligned with organizational strategy- Identifies strategic, innovative solutions- Anticipates emerging customer/market needs
Satisfy the Customer- Understands and anticipates customer needs- Delivers high-quality solutions and service- Proactively maintains satisfaction and loyalty
Plan for Success- Aligns business strategies with actionable plans- Anticipates risks and builds contingency plans- Secures resources for goal achievement
Pursue Execution- Prioritizes time and resources effectively- Holds self and others accountable- Acts to overcome obstacles and improve quality
Tailor Communication- Communicates clearly and professionally- Adjusts style to fit the audience- Explains technical concepts effectively
Build Partnerships- Builds networks across functions- Encourages collaboration and breaks down silos- Involves stakeholders in decisions
Influence Others- Builds support with sound rationale- Gains buy-in from decision makers- Encourages innovative thinking
Develop Self and Others- Enhances interpersonal relationships- Models integrity and company values- Seeks out growth and breakthrough opportunities#LI-MV1Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
CAI Benefits:•Comprehensive Health Insurance coverage•24 days of Paid Time Off•ESOP/401K - 15% Company Contribution (US Only)•Company paid Life Insurance•Company paid Long Term DisabilityWe are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$61k-84k yearly est. 6d ago
Validation Engineer
Commissioning Agents Inc. 3.9
Equipment validation engineer job in Columbus, OH
Are You Ready? CAI is a professional services company established in 1996 that has grown to nearly 800 people worldwide. For mission-critical and regulated industries needing to deliver essential solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard-through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.
Our Purpose
We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
Our Foundational Principles
* At CAI, we are committed to living our values-both professionally and personally:
* We act with integrity
* We serve each other
* We serve society
* We work for our future
* We are relentless in our dedication to excellence, pushing boundaries and redefining industry standards. We thrive at the intersection of wisdom, technology, and humanity-always focused on how it will be done, not how it used to be done.
Key Responsibilities
1. Technical Responsibilities
* Develop documentation for CQV activities
* Write and execute protocols (field verification)
* Develop summary reports at client sites
2. Areas of Focus
* Pharmaceutical facilities
* Utilities
* Equipment
3. Project & Team Management
* Plan and coordinate work
* Direct small teams in document development and/or execution
Qualifications and Experience
* Bachelor's degree in a science or engineering field (or equivalent experience)
* 2-4 years' experience in commissioning and qualification in a regulated industry
* Familiarity with ISPE Baseline Guide 5 (Second Edition) is a plus
* Preferred experience in:
* Facilities and equipment startup
* Walk-downs and troubleshooting
* Utilities (WFI, RO, HVAC)
* Upstream/downstream processing
* Purification, recovery
* Building automation
* Pharmaceutical manufacturing processes
Critical Competencies
Influence Strategy
* Pursues initiatives aligned with organizational strategy
* Identifies strategic, innovative solutions
* Anticipates emerging customer/market needs
Satisfy the Customer
* Understands and anticipates customer needs
* Delivers high-quality solutions and service
* Proactively maintains satisfaction and loyalty
Plan for Success
* Aligns business strategies with actionable plans
* Anticipates risks and builds contingency plans
* Secures resources for goal achievement
Pursue Execution
* Prioritizes time and resources effectively
* Holds self and others accountable
* Acts to overcome obstacles and improve quality
Tailor Communication
* Communicates clearly and professionally
* Adjusts style to fit the audience
* Explains technical concepts effectively
Build Partnerships
* Builds networks across functions
* Encourages collaboration and breaks down silos
* Involves stakeholders in decisions
Influence Others
* Builds support with sound rationale
* Gains buy-in from decision makers
* Encourages innovative thinking
Develop Self and Others
* Enhances interpersonal relationships
* Models integrity and company values
* Seeks out growth and breakthrough opportunities
#LI-MV1
$72,800 - $80,100 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
CAI Benefits:
* Comprehensive Health Insurance coverage
* 24 days of Paid Time Off
* ESOP/401K - 15% Company Contribution (US Only)
* Company paid Life Insurance
* Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
$65k-85k yearly est. 60d+ ago
Fully Qualified Navy Validator III (Remote)
Ishpi Information Technologies 4.4
Remote equipment validation engineer job
Ishpi Information Technologies, Inc. (DBA ISHPI) is passionate about providing our customers with technical solutions that satisfy their business needs. Through collaborative interactions with customers, team members, subject matter experts (SMEs), technical leaders, and partners we design practical solutions that solve real problems for major government and business organizations. As a member of our group, you will work with a team focused on delivering innovative business solutions using emerging technologies through proven successful methods.
Responsibilities
The Fully Qualified Navy Validator III will provide support to the Naval Surface Warfare Command in Philadelphia, PA. Shall assist with the preparation and submission of all RMF A&A and AO packages. All RMF activities shall follow the most current applicabledocuments including DON RMF Process Guide, DoD Instruction 8510.01, and the business rules of cognizant review offices for each package. Shall also produce and maintain RMF artifacts related to the authorization or de-authorization of assigned RMF packages, applications, and systems under the cognizance of NSWCPD.
Qualifications
Education: Requires a Bachelor's degree in Computer Science from an accredited university.
Work Experience: Ten (10) years of professional experience. Experienced in the management of IAT, certification agents and system engineers on the compliance requirements to achieve certification and accreditation IAW the DoD RMF program and the Department of Navy (DON) Chief Information Officer (CIO) IA Policy for PIT Systems. Ten (10) years of support to the DON or DoD, preferably as an IAM, Certification Agent and/or Designated Approval Authority and Certification Authority staff.
Certifications: Fully Qualified Navy Validator certificate. IAM Level II certification.
Security Clearance: Requires U.S. Citizenship and an active government security clearance.
“Ishpi Information Technologies, Inc. is an Equal Opportunity Employer. All qualified candidates will be considered without regard to legally protected characteristics.
Expression of Interest: By applying to this job, you are expressing interest in this position and could be considered for other career opportunities where similar skills and requirements have been identified as a match. Should this match be identified, you may be contacted for this and future openings.
$77k-103k yearly est. Auto-Apply 60d+ ago
Equipment Engineer
Allied Mineral Products 3.8
Equipment validation engineer job in Columbus, OH
**Allied Mineral Products** is a leading manufacturer of monolithic refractories worldwide. We are seeking an **Equipment** **Engineer** in our Columbus, Ohio location. This position ensures optimal performance, safety, and reliability of manufacturing equipment. This role provides technical expertise in equipment design, installation, troubleshooting, and maintenance support.
The EquipmentEngineer works closely with operations and maintenance teams to resolve equipment issues, improve efficiency, and implement solutions that minimize downtime and extend asset life.
**Key Duties and Responsibilities:**
+ Monitor equipment performance and implement design improvements to enhance reliability and efficiency.
+ Collaborate with production, quality, reliability, and affiliate teams to resolve major equipment/system breakdowns and recurring maintenance issues.
+ Develop specifications for bidding and procurement of equipment, materials, and services.
+ Ensure compliance with OSHA, NFPA, ISO, and other applicable safety and quality standards.
+ Maintain technical documentation, including drawings, and manage historical data using CMMS systems
+ Apply Lean methodologies and condition monitoring techniques to identify and execute equipment and process improvement opportunities.
+ Lead plant engineering projects involving equipment modifications or installations from concept to completion.
+ Utilize advanced condition monitoring technologies (ultrasound, thermography, lubrication analysis) and analyze data to drive continuous improvement.
+ Provide global support for equipment-related issues; occasional travel required.
+ Define preventive maintenance procedures and spare parts strategies aligned with reliability and risk management principles.
**Qualifications:**
+ Bachelor's degree in Mechanical Engineering or related technical field, or equivalent work experience.
+ Minimum 5 years of experience in equipmentengineering or maintenance within a manufacturing environment.
+ Strong knowledge of industrial equipment (dust collection systems, pumps, fans, material handling).
+ Proficiency in mechanical and/or electrical design principles; ability to create CAD drawings.
+ Practical hands-on problem-solving experience required.
+ Experience with FMEA and RCA methodologies for root-cause analysis; reliability engineering background preferred.
+ Familiarity with Lean/Continuous Improvement methodologies and process optimization.
+ Demonstrated ability to manage projects end-to-end, including contractor coordination and global support.
+ Proficiency in CMMS systems and maintenance best practices.
+ Excellent written and verbal communication skills and strong interpersonal abilities.
+ Willingness to travel occasionally (less than 5%).
**Working Environment**
+ Office work environment.
+ Frequent exposure to Allied's manufacturing facilities, which may include dusty, hot, or cold conditions.
+ Required to follow Allied Mineral Products' Safety & Health policy and wear Personal Protective Equipment (PPE) as appropriate.
**Total Com** **pensation:**
+ Competitive Base Pay
+ Retirement Plans:
+ Employee Stock Ownership Plan (ESOP) - Allied contributes 25% of your annual earnings into the plan each year
+ 401K program
+ Annual Profit Sharing
+ Paid Time Off for Vacation, Sick Days, Holidays
+ Medical, Prescription Drug, Dental, and Vision programs
+ Life Insurance
+ Short-Term, and Long-Term disability
**Allied Mineral Products Holding, Inc. is an Equal Opportunity Employer/Veterans/Disabled.**
$66k-87k yearly est. 60d+ ago
Senior Equipment Engineer - Day Shift
Illuminate USA
Equipment validation engineer job in Pataskala, OH
Illuminate USA, a new standalone joint venture established by two global leaders in renewable energy, is building one of the largest solar panel manufacturing factories in the Western Hemisphere. This 1.1 million-square-foot factory is currently in advanced stages of preparation in the Columbus, Ohio area. Illuminate USA is seeking highly motivated team members to help the company grow from startup to a full scale, industry leading manufacturer with $1B - $2B expected annual revenue and over 1,200 employees in less than two years.
This will be a fast-paced and exciting time in our history as we are building something great from the ground up here in central Ohio. We offer competitive pay, benefits, and ongoing career development opportunities. Come join our collaborative, people-focused, and innovative workplace as we embark upon this unique and exciting journey!
Job Summary:
As a Senior EquipmentEngineer, you will play a key role in maintaining and enhancing the efficiency of Illuminate's manufacturing process. With a focus on maximizing equipment performance and minimizing downtime, you'll serve as the technical owner for manufacturing tools, addressing challenges related to installation, maintenance, and continuous improvement. This role requires a proactive approach to problem-solving, a deep understanding of equipment functionality, and the ability to coordinate with internal teams and external vendors to implement effective solutions. You'll be instrumental in driving the reliability and growth of Illuminate's manufacturing processes, ensuring that production goals are consistently met with high safety and quality standards.
Responsibilities:
Serve as the primary tool owner in Illuminate's manufacturing process, identifying problems and implementing solutions for equipment development and enhancement.
Oversee installation, modification, upgrades, and maintenance of equipment to ensure manufacturing efficiency and reliability.
Develop and implement programs to improve uptime and address equipment issues affecting the production process.
Coordinate with vendors and contractors for new tool installations, upgrades, and qualifications, ensuring they meet company standards.
Maintain and update equipment records, including manufacturers' technical notices, upgrades, and safety information.
Define, document, and implement preventive maintenance schedules to maintain optimal equipment functionality.
Train and mentor Maintenance Technicians, providing guidance on troubleshooting and upkeep of equipment.
Other duties as assigned.
Qualifications:
Bachelor's Degree in Engineering (equivalent experience may be considered)
7+ years of technical experience in equipmentengineering, ideally within renewable energy manufacturing
Strong knowledge of equipmentengineering and maintenance practices in a manufacturing setting
Proficiency in MS Office Suite (Word, Excel, PowerPoint, Project)
Experience with CAD software preferred
Excellent verbal and written communication skills for cross-functional collaboration
Strong time management skills with the ability to manage tasks independently
Ability to work off-hours as required in a fast-paced manufacturing environment
This role is fully onsite at the Illuminate USA manufacturing facility
Must be able to work a 8-hour shift
Ability to lift, carry, push, or pull up to 30-40 lbs
Frequent walking throughout the production floor, warehouse areas, and outdoor facility spaces.
Illuminate USA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status, or any protected status as defined by law.
Illuminate is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
$73k-105k yearly est. Auto-Apply 5d ago
Validation Engineer, CSV Biopharma (JP12934-R)
3 Key Consulting
Equipment validation engineer job in New Albany, OH
Business Unit: Ops Digital Technology Innovation Employment Type: Contract Duration: 6+ months with likely extension Rate: $35-40/Hr with benefits
Notes: Onsite New Albany, OH - must be local. Standard hours.
3 Key Consulting is hiring! We are recruiting a ValidationEngineer for a consulting engagement with our direct client, a leading global biotechnology company.
Job Description:
Primarily responsible for ensuring adherence to computer validation standards and procedures for computer related systems. Responsibilities include participation in system design, preparation of test protocols, analysis of test results and preparation of summaries. Provides guidance and sets standards in producing quality documentation, serves as the liaison between the IS and Quality functions, provides testing and IT compliance guidance, and provides timely and effective response and follow-through in the resolution of IT Quality/Project compliance issues.
This role is for a strong background in IT Business systems validation, IT Automation systems validation, ensuring that our Information technology systems and processes meet regulatory requirements and industry standards, particularly within the framework of GxP (Good manufacturing Practice) in projects. Integrates a variety of systems technologies to provide systems related solutions to meet business needs. Supports the creation and maintenance of client's Ohio computer systems validation.
Top Must Have Skill Sets:
Experience with testing tools (ALM, or Kneat or ValGenesis).
Experience with ServiceNow (Change Module), Track wise (CAPA, Deviations, Change), Veeva document management, CAPA, Deviations, Change Management.
Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
Understanding of industry standards and best practices for computer system validation such as GAMP 5.
Must have experience with deviations
IT infrastructure tools is highly preferred but not required (example: backup and restore, disaster recovery)
Day to Day Responsibilities:
Perform Deviations, CAPA, Change records for DTI computer systems (E.g: MES, SCADA, ASRS, ServiceNow, QBAS, SAP/ERP, Serialization, etc).
Provide support to system owners on completing Design Spec, URS, Traceability, IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification) draft copies.
Provide support on completion of validation deliverables as required per the project.
Develop and execute test scripts in ALM, Kneat test tools to support system owners/IT Application Owners.
Ensure and track computer systems periodic reviews and periodic access reviews are completed as per schedule to maintain system maintenance phase.
Ensures that systems are maintained in a compliant manner according to the DTI quality systems standards.
Support regulatory inspections and internal audits as required.
Basic Qualifications:
Master degree OR Bachelor degree in Engineering and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience
2. 5+ years relevant experience in computer system validation (E.g: MES, SCADA, Building Management system (BMS, QBAS), Serialization, QC systems).
Experience with ALM or Kneat testing tool is plus.
2. Experience with ServiceNow, Track wise (CAPA, Deviations), Veeva document management, CAPA, Deviations, Change Management.
3. Knowledge of cGMP regulations and guidelines including but not limited to U.S. code of Federal Regulations 21 CFR Part 11 and Part 211.
4. Understanding of industry standards and best practices for computer system validation such as GAMP 5.
Why is the Position Open?
Supplement additional workload on team.
Red Flags:
cannot support onsite operations
Overly long or irrelevant resume
Exaggerated or vague job titles and responsibilities
Lack of achievements or quantifiable results
Interview Process:
WebEx or onsite.
We invite qualified candidates to send your resume to **************************. If you decide that you're not interested in pursuing this particular position, please feel free to take a look at the other positions on our website ******************************* You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards, 3KC Talent Acquisition Team
$35-40 hourly Easy Apply 60d+ ago
Executive Risk Engineer, Equipment Breakdown
Chubb 4.3
Remote equipment validation engineer job
We are currently seeking applicants for an Equipment Breakdown Risk Engineer (EBRE) for our Chicago, IL branch operations. The EBRE professional operates within the Risk Engineering Department and is considered an integral component of the valued added services that we provide for our commercial insurance policy holders. The position will report to the Chicago Risk Engineering Team Lead and directly support our northern Illinois and southern Wisconsin territory.
The primary focus of this position is to perform risk evaluations, evaluate exposures and controls, develop meaningful loss estimates, and communicate findings to business partners. Responsibilities include the application of critical thinking to determine the adequacy of controls, the likelihood of loss, the magnitude of loss, and the overall insurability. The individual will conduct boiler and pressure vessel inspections in accordance with jurisdictional rules by performing thorough examinations, identifying hazardous conditions, applying appropriate codes and standards, recommending corrective action, and submitting required reports. The individual will communicate to customers how these recommendations impact their business and appropriate courses of action. The Equipment Breakdown Risk Engineer will also perform claims investigations which include evaluating the elements of the accident, extent of damage, damage verification, invoice review, and cause of loss. The individual provides risk improvement services to customers, including identifying exposures with significant loss potential, investigation of losses and evaluation of preventative maintenance management programs. Written reports will include evaluations of machinery breakdown and business interruption exposures, which will assist underwriters in evaluating risks and assigning proper premium for the exposure.
This is a remote-based role that has field travel.
Responsibilities
Development of risk improvement reports, recommendations, and other risk assessment documentation
Building and maintaining productive relationships with underwriting and service teams assigned to support the business with agents, claims, and clients
Managing workload within an assigned territory
Taking ownership of the territory and effectively prioritize, plan, and schedule work
Utilizing technology resources for maximum efficiency
Responding to customer requests in a timely and professional manner
Ability to deliver timely, quality service and products to internal and external customers
Qualified candidates will have a minimum of 3 to 5 years of experience inspecting boilers and pressure vessels. In addition, the candidate must be prepared to fulfill any additional requirements of each state jurisdiction in order to obtain state commissions
Candidate must have sound proficiency and experience with industrial, mechanical, and electrical equipment
Counsel and provide presentations to existing customers on a variety of safety related topics
Time management and work planning skills are essential for delivering efficient and productive workflow
Teamwork and advanced communication skills are necessary to achieve business goals
Strong interpersonal skills, including basic business expertise, such as sales, ability to negotiate, and the capability to interact with a wide variety of customers are essential
Additional competencies required to include proficient writing skills, self-management, problem solving, and results orientation
Education And Certification
High school degree is required
Current National Board of Boiler and Pressure Vessel commission is required
Two or four-year college degree in Engineering or Science is desirable, but is not required
Meet Chubb's Risk Engineer, Katelyn Nassie, sharing her expertise and commitment to excellence in serving every Chubb customer:
Katelyn's Story - *******************************************************
Check out our State-of-the-Art Training and Education Center:
Chubb Risk Engineering Center - *********************************************************************************
The pay range for the role is $101,500 to $172,500. The specific offer will depend on an applicant's skills and other factors. This role may also be eligible to participate in a discretionary annual incentive program. Chubb offers a comprehensive benefits package, more details on which can be found on our careers website. The disclosed pay range estimate may be adjusted for the applicable geographic differential for the location in which the position is filled.
$101.5k-172.5k yearly Auto-Apply 33d ago
Learn more about equipment validation engineer jobs