9,792 Validation Specialist jobs in the United States

Description

William Everett is a 10+ year certified minority and women-owned business enterprise headquartered in Chicago. William Everett consulting is trusted by institutions, governments, and Fortune 500 technology companies to help them adapt, evolve, and improve performance.

William Everett consists of seasoned executives and highly skilled consultants with a proven track record of providing sustainable strategies within the private & public sectors. Consulting services include management change services, organizational change management, training, IT & infrastructure improvement, and enablement services to include call center, customer services, help desk and staffing.

We are currently seeking a full-time Data Verification Specialist to join our Parking Management team! The Data Verification Specialist is responsible for accurately reviewing, validating, and/or completing data entry of required data fields from predefined handwritten citation forms, hearing requests, evidence, other correspondence and documents, pictures, and videos.

Requirements

• High School Diploma or equivalent, required.
• Associate's Degree, preferred.
• Commits to minimal absenteeism and maintenance of an excellent attendance record.
• Must be production oriented and comfortable working to meet daily processing goals and targets. Also displays a willingness to sit for entire shift while paying close attention to detail while focusing on manual, repetitive tasks.
• Possesses basic computer skills, including working knowledge of Windows operating system; starting and stopping of various software applications; opening, closing, and saving of electronic files; and utilizing mouse and keyboard for basic functions.
• Possesses general knowledge of other office equipment including printers, copy machines and fax machines.
• Excellent Interpersonal communication skills, written and oral;
• Possesses a positive attitude and pay close attention to detail.

Additional Requirements:

• Ability to pass a criminal background check.
• Vaccinated against COVID-19
• Authorized to work in the US for any employer.
• Commutable to the Chicagoland area.

Job Title: Computer Validation Specialist

Location: Bothell, WA *ONSITE* Local candidates preferred

TOP SKILLS:

1. 3-5+ years' experience in performing periodic review of computerized systems.
2. Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
3. Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ / OQ / PQ), Reports, Trace Matrices, SOPs, etc.).
4. Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.

PURPOSE AND SCOPE OF POSITION (Position Summary):

The Computer Systems Validation (CSV) Analyst works cross-functionally to lead and execute validation activities for GxP electronic systems, with a focus on Systems MES (Emerson) integrations and recipe functions. This role is an individual contributor with occasional oversight of contract resources on a project basis. The CSV Engineer partners with Business Owners, Technical Owners, and Quality to create and manage validation deliverables for site-level electronic systems and applications that integrate with enterprise systems. The CSV Engineer has primary responsibilities to ensure that routine tasks supporting validation of electronic systems and applications supporting clinical and commercial drug product manufacturing are documented in accordance with the relevant company procedures and health authority regulations. This includes leading computer system validation efforts for new system implementations and changes to existing systems as well as coordinating system validation assessments, periodic reviews, and audit activities.

QUALIFICATION REQUIREMENTS (Knowledge, Skills and Abilities):

Education: Master's Degree with 2+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments, OR; Bachelor's Degree with 4+ years of direct experience in Validation in a pharmaceutical, biotechnology, or related industry, preferably in FDA-regulated environments.

PREFERRED QUALIFICATIONS:

1. Experience in a biotechnology or pharmaceutical cGMP manufacturing environment preferred.
2. Experience with development of CSV documentation (Validation Plans, Requirements, Specifications, Assessments, Test Scripts (IQ / OQ / PQ), Reports, Trace Matrices, SOPs, etc.).
3. 3-5+ years' experience in performing periodic review of computerized systems.
4. Experience with Valgenesis/Veeva Vault CR/PR/CAPA systems.
5. Strong critical thinking and problem-solving skills.
6. Strong interpersonal skills to work with teams in different functions and organizations.
7. GXP Equipment Validation.

ROLES AND RESPONSIBILITIES:

1. Lead site-specific CSV activities for computer system integration projects (i.e., ERP, MES etc.), coordinating with the global/site specific system technology and validation teams.
2. Strong knowledge of GAMP / risk-based approaches to validation (i.e., Computer Software Assurance (CSA)), and good understanding of electronic record / signature management practices.
3. Lead routine CSV lifecycle activities (system periodic validation lifecycle and audit trail / user access reviews/Periodic review), coordinating with business owners, technical system owners and Quality in accordance with company procedures and regulatory requirements.
4. Author, review and/or approve applicable CSV documentation.
5. Perform or oversee test script execution efforts, including defect management.
6. Ensure validation test strategies align with internal procedures and requirements for intended use.
7. Assist Business Owners and Technical Owners to develop requirements and specifications for computerized systems used in GxP operations.
8. Experience in following CSV methodology for system evaluations, changes, and implementations.
9. Ability to work independently.
10. Other related duties as assigned.

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*** MUST HAVE;
1. Cleaning validation experience
2. Strong communication skills
3. Rinse and Swab sampling experience
4.Bracketing and worse case rating
5. QC testing requirements
6. Dirty hold times and clean hold times
7. Ability to manage, execute and troubleshoot on their own
8. Strong Microsoft Suite skills

Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok ( .
Job Description
The primary responsibility for the Validation Specialist is the planning and overall approval of validation tasks. Under the direction of the Validation Section Manager, will participate in the implementation of the Validation quality program, but s/he will be expected to independently manage 5+ key projects simultaneously. May be expected to coach/supervise contractors and/or junior Validation Specialists
+ This role serves to provide Quality Assurance oversight of site validation documents/ practices and reports up through the site Quality organization
+ Responsible for participating in implementation and maintenance of the effectiveness of the Quality System to meet all applicable regulatory requirements
+ Ensures that all practices and procedures comply with company policies and applicable regulations for the Quality areas under his/her responsibility
+ Executes tasks as required to implement the Validation Master Plan and maintain in a validated state the equipment, utilities, facilities, automated process controllers, information systems, cleaning processes, manufacturing processes, laboratory instruments and analytical methods to demonstrate that product will perform consistently as intended
+ Ensures investigations of validation failures are completed thoroughly and documented accurately and are included in the plant CAPA system where required by policy
+ Participates with plant and external engineering resources on new installations/systems to ensure that factory/site/commissioning documentation is in accordance with cGMP and supports validation
+ May supervise contract validation resources in the timely completion of activities in his/her area of responsibility
+ May lead, author, or review investigations and implementation of preventive and corrective action
Qualifications
+ Bachelor's Degree Required (preferably in Biology, Chemistry or Engineering)
+ 6+ years of overall experience in Manufacturing, Quality or Engineering including 4 major validation subjects (e.g. Computer, Equipment, Cleaning, Process, etc.) preferred
+ Strong verbal and written communication skills
+ Solid problem solving and analytical skills
+ Solid interpersonal skills, including ability to negotiate/influence without authority
+ Ability to supervise junior or contract team members (prior supervisory experience preferred)
+ Ability to manage complex projects and multiple projects (5+) simultaneously
+ Knowledge of quality / compliance management as well as regulations and standards affecting API, Bulk Drug or Finished goods manufacturing preferred
Key Stakeholders
Various stakeholders within the site including but not limited to Plant Operations, Quality, Engineering/Maintenance, and Science & Technology
Additional Information
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

+ The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary: $82,500 - $57,500
+ We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
+ This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.
US & Puerto Rico only - to learn more, visit & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
$8 ,500 - 157,500

**Associate Validation Specialist**
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The Associate Validation Specialist position shall provide support for cleaning validation as well as its related support areas; NPIx development, validation of analytical test methods, cleaning validation, and continued process verification. The Associate Validation Specialist position shall also provide validation support for change control to validated systems using TrackWise, and validation support during customer and agency audits / interaction with customers.
Working Hours: Monday-Friday 8 AM-5 PM. This role will be 100% on-site in Winchester, Kentucky.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Direct cleaning validation activities; including drafting NPIx risk assessments with review / approval of the NPIx change controls.
+ Direct cleaning validation activities; including authoring and executing specifications and validation documentation for equipment cleaning processes in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes CV protocols/CV reports and Risk Assessments.
+ Direct cleaning validation activities; including execution of protocols / training on the manufacturing floor, collection of samples and tracking samples through to testing, overseeing the Cleaning Validation Master Plan and associated continued process verification monitoring activities.
+ Support of customer and agency audits with cleaning validation documentation and speaking to the data provided.
+ Assist in process development (NPIx), process validation and continued process verification efforts related to authoring and executing specifications and validation documentation for equipment/systems and processes in alignment with Good Manufacturing Practices (GMPs), FDA 21 CFR Part 11 and Annex 11, MHRA Data Integrity. Validation documentation includes NPIx development protocols/reports, Process Validation protocols/reports, Continued Process Verification (CPV) plans/reports, Risk Assessments, and Annual Product Reviews (APRs).
+ Performs qualification activities in line with the project schedules and timelines.
+ Collaborates validation/qualification activities with key stakeholders.
+ Other duties as assigned.
**The Candidate**
+ Associate's Degree or Bachelor's Degree in life sciences (e.g., Chemistry, Biology, etc.) or related field.
+ Experience in the Pharmaceutical, Biotechnology or Medical Devices industry (e.g. in the area of quality control and/or quality assurance) a plus but not required.
+ Working knowledge of GxP, regulatory requirements for pharmaceutical industry (i.e. 21 CFR part 11) and good documentation practices a plus but not required.
+ Proficiency in Microsoft Word, PowerPoint and Excel (basic graphing with statistical analysis of data)
+ Technical Writing Experience Preferred.
+ File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary. Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs. Individual may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
**Why You Should Join Catalent**
+ Several Employee Resource Groups focusing on D&I
+ Tuition Reimbursement - Let us help you finish your degree or earn a new one!
+ Generous 401K match
+ 152 hours accrued PTO + 8 paid holidays
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .