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  • Lead Validation Specialist

    Theradex Oncology 4.1company rating

    Remote equipment validation specialist 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 20d ago
  • Field Validation Specialist - West BU

    Biomat USA, Inc. 4.2company rating

    Remote equipment validation specialist job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. **This is a remote position with up to 75% travel for Candidates on the West Coast of the United States.** **Summary:** Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. **Primary Responsibilities:** + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. + Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. + Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. + Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. + Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: + Writes test cases to validate critical control points, user requirements, and functional designs. + Executes test cases as needed. + Prepares validation reports for distribution. + Ensures milestones and timelines are met on assigned projects. + Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: + Prepares validation equipment for use at the Donor Center and for evaluation upon return. + Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. + Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. + Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. + Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. + Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. **Knowledge, Skills, and Abilities:** + Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. + Excellent quantitative and analytical skills. + Excellent oral and written communication skills. + Strong critical thinking and problem solving skills. + Ability to identify errors and provide corrective action. + Ability to work with others in a team environment. + Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. **Education and Experience:** + Bachelor's degree. + Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. + Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. **Occupational Demands:** Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. **Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.** Learn more about Grifols (************************************** **Req ID:** 537057 **Type:** Regular Full-Time **Job Category:** MANUFACTURING
    $69.4k-104.1k yearly 23d ago
  • Compliance Validation Specialist - Part Time & Remote

    Testpros

    Remote equipment validation specialist job

    TestPros is a successful and growing business, established in 1988 to provide Information Technology (IT) technical support services to a wide range of Commercial and U.S. Federal, State, and Local Government customers. Our capabilities include Program Management, Program Oversight, Process Audit, Intelligence Analysis, Cyber Security, NIST SP 800-171 Assessment and Compliance, Computer Forensics, Software Assurance, Software Testing, Test Automation, Section 508 and WCAG Accessibility Assessment, Localization Testing, Independent Verification and Validation (IV&V), Quality Assurance (QA), Compliance, and Research and Development (R&D) services. TestPros is an Equal Opportunity Employer. TestPros delivers innovative independent IT assessment solutions to critical challenges facing the nation and the world. We support the U.S. Federal Government and Commercial clients within the continental USA. TestPros is dedicated to making lives better, safer and more secure. Job Summary TestPros is seeking a qualified consultant to ensure its websites and mobile applications comply with Web Content Accessibility Guidelines (WCAG) 2.1 Level AA standards as mandated by the U.S. Department of Justice's (DOJ) 2024 final rule under Title II of the Americans with Disabilities Act (ADA). This project aims to improve digital accessibility for individuals with disabilities and align the digital platforms with federal accessibility requirements. Position: Part time (as needed, 1099 or Corp. to Corp) Citizenship: U.S. Citizenship or Green card holder Location: Remote Clearance: None Responsibilities: Re-assess websites and mobile applications post-remediation to confirm WCAG 2.1 compliance. Conduct certification or validation processes for accessibility standards. Deliver final compliance reports, documenting validation results. Qualifications: Expertise in evaluating web and mobile platforms against WCAG 2.1 AA requirements. Familiarity with compliance certification processes. Strong attention to detail and thorough understanding of accessibility testing methods. Proven ability to work with regulatory standards and certifications. Benefits TestPros offers a competitive salary, medical/dental/vision insurance, life insurance, paid time off, paid holidays, 401(k) retirement plan with company match, opportunities for professional growth, cell phone discounts, and much more! All benefits are per TestPros current policies and are subject to change without notice. Benefits are available to full-time employees. TestPros, Inc. is an Equal Opportunity Employer. EEO Statement All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, sexual orientation, gender identity, marital status, age, national origin, protected veteran status, or disability. VEVRAA Federal Contractor.
    $77k-104k yearly est. Auto-Apply 60d+ ago
  • Field Validation Specialist - North BU

    Grifols Sa 4.2company rating

    Remote equipment validation specialist job

    Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This is a remote position with up to 75% travel for candidates in the Central or East Coast of the United States. Summary: Ensures current Good Manufacturing Practices (cGMP) and FDA/Grifols Quality Systems are adhered to throughout the performance, documentation and review of validation protocols in Biomat Donor Centers. Travels to donor center site to perform Operational Qualification/Performance Qualification testing. Primary Responsibilities: * Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: * Executes freezer installation, operational, and performance qualifications on-site at donor centers and other affiliated locations. * Interacts with Donor Center and Field Quality/Operations personnel to facilitate validation testing to ensure timely and documented approval prior to implementation for routine use. * Assists in analyzing validation data to ensure acceptance criteria are met and participates in writing validation summaries. * Communicates with Field Quality/Operations and other Operational and Quality Assurance personnel where necessary on Donor Center compliance and cGMP issues. * Assists in ensuring validation approaches are current to regulatory expectations and standards within the industry: * Writes test cases to validate critical control points, user requirements, and functional designs. * Executes test cases as needed. * Prepares validation reports for distribution. * Ensures milestones and timelines are met on assigned projects. * Participates in the evaluation of processes, systems, and individual center equipment needs and final approval process: * Prepares validation equipment for use at the Donor Center and for evaluation upon return. * Assists in identifying and determining actions to add, remove, and/or revalidate processes, systems, and equipment including evaluation of new/updated methodologies/applications/equipment and resolution of issues or problems with performance, transfer, or service. * Tracks and monitors process/system failures/events. Provides feedback to Donor Center management regarding requirements, results from data collected, and validation processes. * Tracks and monitors equipment calibration due dates and calibration failures/events. Provides feedback to Donor Center management regarding equipment calibration due dates, requirements, results from data collected, and validation processes. * Prepares donor center staff for validation activity as necessary and conducts training with donor center teams where applicable. * Travels on-site up to 75% as needed to ensure timely validation completion within the Geo. Knowledge, Skills, and Abilities: * Strong knowledge of current Good Manufacturing Practices (cGMPs) operating procedures and standard operating procedures. * Excellent quantitative and analytical skills. * Excellent oral and written communication skills. * Strong critical thinking and problem solving skills. * Ability to identify errors and provide corrective action. * Ability to work with others in a team environment. * Knowledge of Microsoft Office applications and computer applications used in the Donor Centers. Education and Experience: * Bachelor's degree. * Typically requires 2 years of quality and validation experience in a cGMP and/or IT environment. * Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor's degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate's degree with 6 years of experience, or a Master's degree with 2 years of experience. Occupational Demands: Occupational Demands Form # 34: Work is performed in an office and a laboratory/manufacturing environment. Exposure to biological fluids with potential exposure to infectious organisms. Exposed to occasional extreme cold below 32* and high levels of noise in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Frequently sits for 4-6 hours per day. May stand; bends and twists neck and waist for 2-4 hours per day. Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Occasionally walks. Repetitive foot movements. Light to moderate lifting and carrying objects with a maximum lift of 50lbs. Near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures. Pay scale of $69,422.00 - $104,134.00 per year for US Residents depending on training, education and experience. This position is eligible to participate in up to 5% of the company bonus pool. We offer benefits including medical, PTO, up to 5% 401K match, and tuition reimbursement. We are committed to offering our employees opportunities for professional growth and career progression. Even though we are a global healthcare company with employees in 30 countries, Grifols prides itself on its family-like culture. Our company has more than tripled its workforce in the last 10 years - we're growing, and you can grow with us! #BiomatUSA #LI-KS1 #LI-Remote Third Party Agency and Recruiter Notice: Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate. Grifols provides equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location: NORTH AMERICA : USA : Home Office:[[cust_building]]
    $69.4k-104.1k yearly 22d ago
  • DRG Validation Specialist

    Maine Health 4.4company rating

    Remote equipment validation specialist 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. 36d ago
  • LL01-082525 Validation Specialist (Packaging) - Ohio

    Validation & Engineering Group

    Equipment validation specialist job in New Albany, OH

    Job Description Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Specialist for Packaging Lines Equipment Periodic Review Qualifications: Bachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in commissioning, qualification and validation of packaging lines (Carton labeler, autoinjector labeler, buffer accumulator, Cartoner, case packer, palletizer, Systech Sentri vision systems) Must be proficient using MS Windows and Microsoft Office applications. Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance. Experience in Design Documentation (URS, DS), IQ, OQ, PQ, Periodic reviews protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Strong knowledge in Packaging equipment. Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.
    $63k-83k yearly est. 17d ago
  • Sr. Validation Engineer

    VWR, Part of Avantor 4.8company rating

    Remote equipment validation specialist job

    The Opportunity: Avantor is looking for a Sr. Validation Engineer to provide specialized knowledge in developing the strategy for equipment for processes and works with the validation team to ensure proper installation, operational and performance qualification of each piece of equipment up to and including all associated documentation. This includes products for medical device, excipient and bio-pharma manufacturing. Prepares all protocols and reports for validation work. Coordinates all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. The Sr. Validation Engineer is responsible for the theory and content of validation documents for equipment, processes, systems, software, changes and on-going review and revalidation of said items to ensure that validation documentation is compliant with validation requirements and policies. Provides facility, equipment and process qualification technical expertise. Author validation documents and execute validations of equipment, control systems and production processes. Directs the life cycle of launched products to support development of manufacturing processes, drive right-first time metrics, and reduce product rejects. Has responsibility for self-identification of process optimization opportunities, and detailed assessment of opportunities (process risk, financial cost/benefits, etc.). Participates in cross-functional assessments, as required to evaluate optimization opportunities/issues. Coordinate and lead validations to assure compliance with customer's requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC for all departments within Avantor. This role will be a hybrid position based out of our Solon, Ohio facility (or near other Avantor sites - St. Louis, Kentucky, Phillipsburg, NJ) with 25% travel for projects. What we're looking for: Education: BS degree in Engineering or Life Science (Chemistry, Bio, Physics, etc.) preferred Experience: 5+ years of experience in an Equipment, Cleaning, and/or Process Validation Engineering experience within a pharmaceutical or medical device company Knowledge of Industrial Quality Control, Quality Engineering, Quality Assurance and Validation, CFRs and their application to Medical Devices Knowledge of software packages supporting statistical data analysis, word processing, flow charting, and project management Familiarity and understanding of manufacturing methods related to the production of medical devices and related products Familiarity and understanding of technical disciplines related to Quality Control, including Engineering and process controls Strong communication skills, both verbal and written; ability to work and interface with all levels Use of computers and peripherals related to validation execution and document authoring Ability to work independently and as a team member, as well as, with Consultants/Contractors to achieve projects' validation objectives Ability to analyze, investigate and propose approaches to technical and regulatory issues Ability to manage multiple concurrent tasks/studies Ability to execute the Validation Plans for medical device and related product manufacturing equipment and facilities Ability to travel to other sites. How you will thrive and create an impact: Interface effectively with management personnel in IT, Engineering, Quality, R&D, Sales and other technical disciplines. Provide technical decision making regarding validation strategies and requirements for large scale and complex projects. Author and approve validation plans, validation protocols, risk assessments, traceability matrices, validation reports, and other documents supporting validation for new and existing manufacturing equipment and processes. Perform, coordinate, and manage qualification testing. Represent Company in contacts with regulatory agencies, including interface with FDA inspectors and presentations to FDA management personnel in regards to validation activities. Coordinate the DQ, IQ, OQ, PQ and PV of all validation activities to assure compliance with customer requirements, ISO 9001 & 13485, 21 CFR 210 & 211, 21CFR 820 ICH Q7 and IPEC. Identify any areas for improvement and propose / implement approved necessary changes. Prepares, writes, and reviews validation protocols, Master Validation Plan (MVP), and documentation to ensure compliance and adherence to AVANTOR's SOP's, Customer specifications, ISO9001, ISO 13485, 21CFR820 and other applicable regulations. This includes regulatory bodies in the US and International. Maintains all Validations and assures they are updated as required. Periodic review is established based on a data review of quality inputs and outputs to assure outcome is as expected. Review need for validation with design group all processes, equipment, methods etc. Responsible for performing validation and managing large size validation projects and supervising technicians/engineers, providing necessary leadership and guidance. Responsible for the generation of protocols using a risk based approach that meets current regulatory requirements and industry practices, as well as performing design qualification. Responsible for managing to validation metrics. Performs other duties as assigned Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! Pay Transparency: The expected pre-tax pay for this position is $77,300.00 - $128,700.00 Actual pay may differ depending on relevant factors such as prior experience and geographic location. EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at ****************************** and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. For more information about equal employment opportunity protections, please view the Know Your Rights poster. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation. Avantor offers a comprehensive benefits package including medical, dental, and vision coverage, wellness programs, health savings and flexible spending accounts, a 401(k) plan with company match, and an employee stock purchase program. Employees also receive 11 paid holidays, accrue 18 PTO days annually, are eligible for volunteer time off and 6 weeks of 100% paid parental leave (except in states that offer paid family leave). These benefits may not apply to employees covered by a collective bargaining agreement or those subject to other eligibility rules.
    $77.3k-128.7k yearly Auto-Apply 3d ago
  • Process Validation Engineer, Expert

    Agilent Technologies, Inc. 4.8company rating

    Remote equipment validation specialist job

    Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek -- so they can do what they do best: improve the world around us. Information about Agilent is available at **************** The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines. Agilent Technologies Nucleic Acids Solutions Division is looking to for a Process Validation Engineer to join their Process Validation team working at their state-of-the-art, contract Active Pharmaceutical Ingredient manufacturing facility that specializes in oligonucleotide chemistries located in Boulder and Frederick, Colorado. Job Description As a Process Validation Engineer within the Process Validation team of Agilent Technologies Nucleic Acid Solution Division, the candidate will be responsible for executing process validation activities of oligonucleotide Active Pharmaceutical Ingredient (API) manufacturing. The responsibilities may include: * Compile, generate and review process inputs and outputs using statistical process control measures for product quality and process consistency reports. * Perform process characterization / validation studies at the bench and in a plant setting, including contributing to the design and writing of the study and associated study documents. * Facilitate multiple aspects of an API process qualification strategy through designing/ authoring/executing/reporting/ investigating of process qualification studies. * Contribute knowledge and ideas for the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Support the design and execution of Design of Experiments (DOE) and Proven Acceptable Range (PAR) experiments for design space understanding and process validation as they relate to oligonucleotide upstream and downstream operations. * Supports all areas of process validation from FDAs Product Lifecycle Stages 1, 2 and 3. * Provide work product updates to clients and project teams in the form of slides, memos and reports. * Maintains process compliance integrity by adhering to standard operating procedures and current good manufacturing practices. * Contribute knowledge and ideas for process optimization, scale-up and laboratory process transfer to mid and kilo scale GMP manufacturing. Qualifications * Bachelor's degree (B. S.) or equivalent in chemistry, chemical engineering or related applied sciences field * Knowledge and 8+ experience in a GMP API setting. * Knowledge and understanding unit operations and associated control strategy of an oligonucleotide manufacturing process or like process. * Knowledge and experience in process validation studies at the bench and in a plant setting. * Knowledge and experience in the development of manufacturing control strategies, methods and techniques in synthesizing, purifying, identification and control of impurities. * Knowledge and experience in designing, conducting, and statistical interpretation in Design of Experimentation (DOE), preferably using SAS JMP software is highly desirable #LI-TH1 Additional Details This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least November 17, 2025 or until the job is no longer posted. The full-time equivalent pay range for this position is $105,280.00 - $164,500.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: ************************************* Agilent Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email job_******************* or contact ***************. For more information about equal employment opportunity protections, please visit ********************************* Travel Required: No Shift: Day Duration: No End Date Job Function: R&D
    $105.3k-164.5k yearly Auto-Apply 31d ago
  • Sr. Navy Qualified Validator ( NQV) Philadelphia, PA

    Watershed Security

    Remote equipment validation specialist 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 11d ago
  • FMS Verification & Validation Engineer- Aerospace Industry

    DBSI Services 3.5company rating

    Remote equipment validation specialist job

    Benefits: 401(k) 401(k) matching FMS Verification & Validation Engineer 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
  • Senior Battery Validation Engineer

    Ford Global

    Remote equipment validation specialist job

    We are the movers of the world and the makers of the future. We get up every day, roll up our sleeves and build a better world -- together. At Ford, we're all a part of something bigger than ourselves. Are you ready to change the way the world moves? Ford's Electric Vehicles, Digital and Design (EVDD) team is charged with delivering the company's vision of a fully electric transportation future. EVDD is customer-obsessed, entrepreneurial, and data-driven and is dedicated to delivering industry-leading customer experience for electric vehicle buyers and owners. You'll join an agile team of doers pioneering our EV future by working collaboratively, staying focused on only what matters, and delivering excellence day in and day out. Join us to make positive change by helping build a better world where every person is free to move and pursue their dreams. In this position... The Battery Validation Engineer will be responsible for enabling innovation through quick testing and characterization of battery components and systems. This individual will define test plans, execute them safely, and report results in order to successfully validate Ford's next generation of EV batteries. You'll have… Bachelor's degree in engineering or related field 5+ years of experience in battery testing and validation Experience with battery test equipment, instrumentation, and data acquisition systems Knowledge of battery chemistry, physics, and safety standards Ability to work independently and collaboratively in a fast-paced environment Strong problem-solving, communication, and project management skills Knowledge of statistical analysis and design-of-experiment Experience in test fixture design and fabrication; 3-D CAD experience preferred Experience in structural, electrical, thermal, and mechanical systems Familiarity with US and international battery safety requirements/regulations Hands-on experience in HV battery system abuse testing Ability to travel to external test labs as needed Even better, you may have… Master's degree in engineering Hands-on experience building and launching automotive products Experience in configuration, development and maintenance of automated test systems Strong written and verbal communication skills Experience using Confluence, Jira, Jama, or other project management tools An eagerness to work cross-functionally in a dynamic environment where you are part of a high performing team A system approach to design and development with the desire and curiosity to strive for exceptional delivery execution and continuous improvement 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 salary grade 8. For more information on salary and benefits, click here: ***************************** This position is a range of salary grades 5-8 . Visa sponsorship is 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. We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, age, sex, national origin, sexual orientation, gender identity, disability status or protected veteran status. In the United States, if you need a reasonable accommodation for the online application process due to a disability, please call **************. Onsite work of up to four days per week may be required for candidates within commuting distance of a Ford hub location. #LI-Hybrid #LI-HA1 What you'll do... Plan, coordinate, and execute battery pack validation tests covering various categories including performance, durability, and abuse Author test scripts for equipment including cyclers, chambers, chillers, and DAQ systems Own data storage and visualization Analyze test data and generate test reports, evaluating compliance with requirements and identifying issues or opportunities for improvement Work alongside systems engineers to define requirements Work alongside cell engineers to define test profiles and correlate cell and pack results Work alongside prototyping and logistics teams to coordinate sample assembly and delivery Work cross-functionally across engineering, manufacturing, quality, and service to communicate test results and provide feedback on battery design and integration Assist battery part owners to develop component-level tests Setup data acquisition systems and specialized measurement equipment as needed Work with fabrication team as needed to design and build custom fixtures Manage external vendors and partners for additional testing capabilities
    $91k-122k yearly est. Auto-Apply 60d+ ago
  • Validation Engineer

    PSC Biotech 3.9company rating

    Equipment validation specialist job in Columbus, OH

    Job DescriptionPSC 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 validation engineers 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 validation engineering 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. 27d ago
  • Validation Engineer

    Cai 4.8company rating

    Equipment validation specialist 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-MV1We 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).
    $61k-84k yearly est. Auto-Apply 60d+ ago
  • Engineer II, Validation

    Moderna Theraputics

    Remote equipment validation specialist 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 40d ago
  • Validation Engineer

    Commissioning Agents Inc. 3.9company rating

    Equipment validation specialist 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 4.4company rating

    Remote equipment validation specialist 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
  • Process & Validation Engineer (100% Travel)

    Syner-G Biopharma Group

    Remote equipment validation specialist 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 Validation Engineering 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. -- VALIDATION ENGINEER POSITION OVERVIEW: We are seeking a Validation Engineer to assist with the development and execution of validation protocols for various types of processes. The Validation Engineer 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 21d ago
  • Solution Validation Engineer

    Latticesemi

    Remote equipment validation specialist 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 Responsibilities: Perform system validation to assure the quality of solution stacks. Perform software validation to assure the quality of embedded software including Driver and Firmware. Perform software development tools testing such as Propel SDK, Builder and solution tool. Create the automation test suite/cases and develop automated testing scripts. Work with cross function teams for system and software validation. Required Skills, Experience BS/MS/PhD in Electronics or Computer Engineering with minimum of 10 years' experience of Embedded System/SW automation test development. Familiar with automated testing flow and framework. Programming skill with Python and C is a must, experiences in C++ or Java will be a plus. Experience in one or more of the following areas will be a plus: RISC architecture and micro-architecture (RISCV, ARM) Embedded Peripheral communication Protocols (PCIE, SPI, I2C, I3C, UART etc.) FPGA design flow Proficiency with bench equipment such as Oscilloscopes, Protocol Exerciser/Analyzers to perform system level validation on hardware. Strong written and verbal communication skills and the ability to work with multiple groups. Familiar with Windows/Linux OS. Strong teamwork spirit and be able to solve problems independently. 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.
    $71k-94k yearly est. Auto-Apply 23h ago
  • Validation Engineer, CSV Biopharma (JP13826)

    3 Key Consulting

    Equipment validation specialist job in New Albany, OH

    Business Unit: Ops Digital Technology Innovation Employment Type: Contract Duration: 6+ months with likely extension Rate: $35-40/Hr on W2 with benefits Target start date : 4/28/25 Notes: Onsite New Albany, OH - must be local. Standard hours. 3 Key Consulting is hiring! We are recruiting a CSV Validation Engineer for a consulting engagement with our direct client, a leading global biotechnology company. The ideal candidate: 3-5 years of experience in computerized system validation, deviation management, CAPAs, and change tickets within a GMP-regulated pharmaceutical, biotechnology, or life sciences environment. They must hold a Bachelor's or master's degree in computer science, Information Technology, Management Information Systems, Mechanical Engineering, or a related field, with a Master's degree acceptable only if accompanied by at least 3 years of industry experience (no fresh graduates). The role requires onsite work with limited training time, so candidates must be able to hit the ground running. Overqualified candidates (e.g., PhDs or those with 15+ years of experience) may not be the best fit. Strong preference will be given to candidates from a pharmaceutical, biotechnology, or life sciences background. 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: No experience on Computer system validation/ validation process. No experience on Deviations. Fresh graduates with no validation or industry experience. Lack of experience with computer system validation or deviation management. No background in Pharma, Biotech, Life Sciences, or relevant IT/Validation roles. Candidates switching from unrelated industries (since training time is limited). Overqualified candidates with 15-20+ years of experience and/or candidates with PhDs. Interview Process: WebEx or onsite. Interview rounds: Typically 2 rounds (with hiring manager and his manager), but could extend to 3 rounds if needed 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
  • Validation Engineer

    Syner-G

    Remote equipment validation specialist 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: We are seeking a hands-on Validation Engineer with a strong background in mechanical or manufacturing engineering, who brings expertise in automated manufacturing environments, preferably within the life sciences or biopharma industry. This role combines engineering document reviews, equipment startup support, and process/manufacturing engineering with project management and cross-functional communication responsibilities. The ideal candidate will have experience in line layouts, fixture design, and 3D printing, with a preference for knowledge of filling and capping equipment. While this is not a controls engineering role, familiarity with PLCs and HMIs is required. The role also involves managing smaller projects and collaborating across teams to ensure successful execution in GMP-regulated environments. Proficiency in AutoCAD and SolidWorks is essential. WORK LOCATION: Travel to client sites may be required up to 100%, depending on project demands and client expectations. KEY RESPONISIBILITIES: Perform equipment qualifications including Commissioning, IQ, OQ, and PQ. Provide hands-on engineering support during equipment startup and validation activities. Conduct engineering document reviews and contribute to process improvement initiatives. Write, review, approve, and execute validation protocols and reports. Lead and mentor a small team of CQV engineers. Collaborate with scientists, technicians, engineers, and project managers to deliver validated equipment and facilities. Ensure validation programs meet GMP, FDA, and ISO standards. Support design and execution of verification tests and validation strategies. Coordinate with cross-functional teams and vendors to meet project milestones. Contribute to layout planning and fixture design, leveraging 3D printing where applicable. Communicate effectively across disciplines to define requirements and deliver solutions. QUALIFICATIONS & REQUIREMENTS: Education : Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, or a related life science field. Technical Experience : 5-7 years of experience in biotech, pharmaceutical, or medical device industries. Strong understanding of GMP, FDA regulations, FMEA, and risk analysis. Experience with validation disciplines including Equipment, CSV, Method, and Process. Skilled in protocol generation and validation of automated production systems. Proficient in AutoCAD and SolidWorks. Familiarity with PLCs, HMIs, and automated manufacturing systems. Experience with high-speed fill-finish lines is a plus. Skills and Abilities : Strong leadership and project management skills. Excellent communication and stakeholder engagement across functions. Ability to manage vendors and contractors effectively. Hands-on approach to engineering and problem-solving. Willingness to travel up to 100% for client site projects. 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. 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.
    $73k-95k yearly est. 25d ago

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