A Validation Manager is responsible for validating and coordinating the operations of machinery and process within the plant. Key responsibilities are listed on the Validation Manager Resume as – managing all operational validation activities within the organisation, developing and implementing a compliant validation strategy for the client, developing and implementing an efficient compliant and cost-effective calibration and maintenance program, managing the process for the creation of documentation and requirements, cleaning validation plans, and managing all facets of assigned validation projects as needed.
Skills and qualifications include the following – a good understanding and application of GMP and regulatory requirements, experience with a wide range of validations including computer system validation, equipment cleaning, and facilities validation plans. A Degree in fields such as science, engineering, or computer science is needed.
Headline : Creative and resourceful problem solver with excellent written communication skills, quality systems and management experience. Certified computer repair technician, freelance writer, author, and award-winning board game designer.
Skills : Microsoft Office, QA And Compliance.
Description :
Managed budget of $700K supporting 27 projects with 0% variance.
Developed plan for onboarding new hires.
Assisted in hiring and coaching of new employees.
Coached project teams in gathering requirements, deploying changes to ERP, authoring test scripts, and executing data migrations.
Performed requirements, design, and test documentation reviews.
Served as product owner for the project implemented using Agile methodology.
Groomed requirements in Rally and provided in-person training to 200+ users.
Experience
5-7 Years
Level
Junior
Education
Bachelor Of Science In Chemistry
Validation Manager Resume
Objective : As a Validation Manager, responsible for Auditing of validation documents (URS, IQ, OQ, PQ, PV, CSV, CV) as well as engineering and maintenance records for compliance with regulatory guidelines as well as Amgen policies and report the findings to the plants management team.
Ensured test results are documented and published in a clear, concise, and timely manner.
Troubleshoot and resolved issues that arise during testing.
Extensived domestic and international travel to test sites and fleet drives.
Ensured the team follows the defined processes (as defined in ITMS and the validation approach).
Provided guidance on the compliance requirements defined within the Smart Controls.
Provided support to team members on aspects of the ITMS methodology as appropriate.
Provided assurance that development processes are controlled, and sufficient evidence is available.
Experience
2-5 Years
Level
Executive
Education
Bachelor In Mechanical Engineering
Validation Manager Resume
Summary : Validation Manager with over 20 years of experience within pharmaceutical, biopharmaceutical, diagnostic and medical device industries. Proven team builder and experienced presenter in leadership for Quality Assurance, Quality Systems and Validation. Proven technical project leader with management experience with interdisciplinary teams from planning to start-up to transfer and commercial manufacturing.
Skills : Ms Office Suite, Internal Auditing, Supervisory.
Description :
Modernized computer validation processes to include risk management practices based on GAMP standards.
Created standard deliverable templates that reduced implementation time by 75%.
Managed change control program and presided over board that evaluated 300 changes annually.
Designed metrics that reduced emergency changes by 30% and increased schedule attainment by 50% over 4 years.
Created role of IT Quality in existing IT organisation.
Managed online accounting section including the review and support of 60 drawings per month.
Reduced testing by eliminating redundancy between Operational Qualification (OQ) and Performance Qualification (PQ) scripts.
Experience
10+ Years
Level
Senior
Education
Certification In Project Management
Validation Manager Resume
Objective : Validation Manager is responsible for all aspects of qualification and validation associated with three CMO facilities used for aseptic processing of sterile drug substances and drug products, as well as manufacture non-sterile medical devices, intermediate drug substances, and drug products used for aseptic processing of sterile drug substances and drug products, as well as manufacture non-sterile medical devices, intermediate drug substances, and drug products.
Performed audits and assessments for Building 7 protocols based on current regulatory guidelines.
Ensured Validation Deliverables are produced in accordance with computer system validation requirements.
Communicated with system owners responsible for expediting corrections on the documents based on the findings.
Contacted clients and develop business relations while over -sighting the entire validation activities in the region.
Managed the lottery's Validation section including resolution of claims.
Provided direction to regional office staff, related to validation issues.
Reviewed promotion rules and provide guidance on validation and tax issues.
Experience
2-5 Years
Level
Executive
Education
Bachelor In Mechanical Engineering
Validation Manager Resume
Objective : Diverse biotechnology professional with experience in manufacturing, quality, validation, project/portfolio management, and business integration. Strong leadership and analytical skills with proven ability to manage/execute multiple tasks within a direct reporting organisational structure and cross-functional matrix team.
Developed the integrated commissioning and qualification program for the Novartis V&D Holly Springs Greenfield site.
Provided global validation support to the Novartis V&D network.
Responsible for all commissioning, qualification, and cleaning validation activities for the Holly Springs US Flu Cell Culture Bulk Manufacturing and Warehouse buildings.
Assisted with development of a Lean protocol writing strategy including authoring of protocol test form templates.
Leveraged 100% of FAT testing as qualification testing as defined in validation plans.
Led interactive planning sessions, as well as C&Q strategy and schedule development for the MARS project in Mar burg, Germany.
Responsible for designing the validation strategies and ensuring the appropriate validation policies and procedures are followed.
Experience
2-5 Years
Level
Junior
Education
MS
Validation Manager Resume
Summary : Over 15 years of manufacturing and quality leadership experience working for Global Fortune 500 companies. More than 12 years of management experience manufacturing small and large molecule pharmaceuticals. Strategic thinker with the ability to assess and communicate with diverse cross-functional teams. Experienced in resource, project and budget, planning and management.
Skills : Microsoft Office Suite, Report Management.
Description :
Led a team of scientists/engineers responsible for Cleaning Validation (CV), Material Qualification (MQ), and Quality Improvement projects for small volume par enteral, plasma derived biologic.
Established a QA Validation group responsible for the development, execution, deviation resolution, review and approval of qualification/validation protocols and reports.
Reviewed and established requirements and approved protocols for all Validation areas (Process, Equipment, Shipping, etc.).
Provided quality expertise and assistance to other departments in support of their quality systems such as Non-Conformance, Change Control, Annual Product Review, Supplier Quality and Regulatory submissions.
Interacted with and submitted responses to regulatory audits from Europe, Brazil, Japan, Canada, Mexico and US.
Participated directly in the audit management process as a guest internal auditor, and supported the external inspection war room.
Supported the product transfer, validation and approval of the BabyBIG product at the Los Angeles site.
Experience
10+ Years
Level
Senior
Education
Ph.D. In Inorganic Chemistry
Validation Manager Resume
Headline : Validation Manager with a record of success developing and deploying silicon test solutions. A self-motivated and collaborative team player with strengths in DFT, test architecture, test data analysis and EDA tool automation. Successful at matching complex requirements to solutions and delivering results as a leader, manager and technical contributor.
Skills : Technical Skills, Cost Management.
Description :
Led a team of six people to plan and execute all site validation activities.
Activities included preparation and execution of validation protocols and reports, validation projects, and validation master plans.
Led the cross-functional Validation Change Review Board.
Products included aseptic ointment, tablets, API, oral liquids, suppositories and inhalation devices.
Successfully led the department through a cultural change from a small company to a large company/high compliance environment.
Increased department from one to six employees.
Pioneered a cost-effective, risk-based change control process.
Experience
5-7 Years
Level
Executive
Education
MBA
Validation Manager Resume
Summary : As a Validation Manager, responsible for Establishing and implementing a Risk Based Validation Program including a Facility Validation Master Plan, Cleaning Validation Master Plan 21 CFR Part 11 Assessment & Remediation Policy, Periodic Validation Review / Revalidation SOP for direct impact systems.
Skills : Technical Skills, Manufacturing Skills.
Description :
Managed the installation, commissioning, startup and qualification of a new multi-product facility including an ISO-5 / FDA Class 100 / EU Grade A, aseptic filling suite and ancillary support areas used to fill, lyophilize and seal and package sterile drug products.
Managed the installation, commissioning, startup and qualification of a multi-product facility including used to manufacture non-sterile medical devices, intermediate drug substances, and drug products.
Performed manufacturing process performance qualification.
Managed aseptic process simulation media fill program.
Managed Change Control Committee.
Managed the validation and revalidation of all changes to CMO processes ensuring changes are consistent with regulatory and internal corporate requirements including cGMP and CFRs.
Responsible for project management of a team of process engineers, analytical scientists and CMOs engaged in the validation of facilities/utilities, manufacturing equipment and processes, analytical test methods, IT Compliance as well as shipping, labeling and packaging within the Engineering and Operations Department.
Experience
10+ Years
Level
Senior
Education
Certificate In Biotechnology
Validation Manager Resume
Summary : Validation Manager Professional with 16 years in the FDA regulated industries. Certified QMS auditor. Experience in Quality Leadership, Quality Assurance, Quality Systems (Audit/ Deviation/ CAPA/ Change Management), Compliance, Auditing, Sterility Assurance, and Process Excellence/Quality Engineering and Facility Start-ups. Worked with various regulations and standards for Biologics/Drugs/Devices 600, 210, 211, EU, Brazil ANVISA, WHO, Japan PAL, and Gulf States).
Responsible for Fill Finish group change control program.
Successfully identified source of microbial contamination and performed mitigation activities for a persistent re-occuring aseptic filling area microbial contamination failures that ultimately led to the total shutdown of the facility prior to me coming on board.
Managed facility EO/GAMMA revalidation program.
Participated in facility production schedule with regards to routine revalidation.
Maintained the groups OEE program.
Submitted annual validation group budgets.
Imitated deviations and conducted investigations into revalidation failures and mitigate product impact.
Experience
10+ Years
Level
Senior
Education
Bachelors In Biochemistry
Validation Manager Resume
Summary : Validation Manager is responsible for project management of a team of process engineers, analytical scientists and CMOs engaged in the validation of facilities/utilities, manufacturing equipment and processes, analytical test methods, IT Compliance as well as shipping, labeling and packaging within the Engineering and Operations Department.
Established and implemented a Risk Based Validation Program including a Facility Validation Master Plan, Cleaning Validation Master Plan 21 CFR Part 11 Assessment & Remediation Policy, Periodic Validation Review / Revalidation SOP for direct impact systems.
Developed a global website to share Cleaning Validation documentation, training materials and best practices and foster network collaboration.
Planned, setup and executed vehicle testing including performance, durability, and fleet validation tests.
Led & Own the Test Process for Vehicle Acceptance Testing / Validation.
Led and mentored a team of engineers to execute tests to qualify all vehicle trim levels and ensure vehicle is ready for production.
Led the Implementation of Test Standards, Best Practices and Workflows as required
Collaborated with system, feature, and attribute owners to ensure a complete vehicle validation plan.
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