Validation jobs in Irvington, NJCreate job alerts

Director, Analytical External Capabilities, Validation & Compliance (ECVC).

The primary focus for this role is to lead and manage the instructional design, the training development for instructor-led, on-the-job, and computer-based training courses that support the Business Process Management portfolio of projects. Partner with other members the Cell Therapy Operations T...

Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required. Management of the GMP quality assurance oversight of Qualification, Valid...

Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems. Create and modify validation documentation including but not limited to: User Requirements Specifications (URS) Design Reviews (DR) Criticality assessments CSV prot...

Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA's. Execute and/or approve deliverables for the Site Validation Plan enabling overall strategic impl...

Support cross functional teams in processing documents (assist in document editing, review, approvals).Document Control Management/Training processes.Revise SOPs related to Document Control/Training on an as needed basis.Help to support the management and maintenance the electronic document manag...

Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities. Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requi...

Develops validation/qualification deliverables such as Validation Plans, Requirements Specifications, Traceability Matrices, Summary Reports, Change Controls. Supports the execution of equipment qualifications and validation protocols. Supports equipment qualification and systems validation activ...

Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems. Create and modify validation documentation including User Requirements. Test/Validation Summary Report.

Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC and other GMP support areas. Review and approval of deviations / non-conformances and lead the strategic discussion for inve...

Requires a 4-yr engineering degree or substitute experience; a graduate degree in engineering, technical, or management discipline is preferred.Validation (IQ,OQ,PQ) or PPAP (Production Part Approval Process) required.Experience in medical device industry required.Knowledge of GMP/ISO/21 CFR 820 ...

Bachelor's degree in scientific or engineering discipline along with plus years of experience in the field of computer validation, Data Integrity compliance. Experience with all pertinent industry best practices (, ISPE GAMP) including development and execution of all applicable system life cycle...

Leading regulatory reporting validation testing including regulatory reporting quality assurance, capital planning (CCAR), and liquidity control validation. Oversight of the planning, performance, and independent validation to safeguard external reporting integrity, including CCAR and liquidity c...

Our client in Ramsey, NJ is hiring a Validation Engineer that will be responsible for preperation of validation protocols (IQ/OQ) and commissioning documents for their equipment and control systems. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory...

Exceptional attention to detail and the ability to review technical documentation thoroughly. We are hiring an experienced and motivated Validation Project Manager to plan, execute, and manage CQV projects, manage vendors, and provide technical execution review. Collaborate with technical teams, ...

Quality Management, Quality Assurance.We are a leading world supplier of integrated processing solutions for customers in the area of pharmaceuticals, food processing, feeds and fine chemicals.Our products and services stand for reliability and quality worldwide.About 3,000 employees work for Gla...

Work cross-functionally to execute validation activities and prepare validation deliverables for S12 Enterprise Manufacturing Execution System (EMES) used in cell therapy manufacturing. Will be responsible for ensuring the validation of the S12 Enterprise Manufacturing Execution System (EMES), an...

Reviewing and approving validation protocols and summary reports generated by the validation staff against standard operating procedures and policies as well as providing guidance to validation staff that execute protocols and draft associated deviations and final reports. This position implement...

Job Title: Validation Specialist. As a Validation Specialist, you will:. Review, approve, and execute test protocols, validation deliverables, and plans as needed.

Modem system validation engineer. Partner with RF Engineering to help drive best-in-class RF network design to achieve the performance objectives.

Strong knowledge of FDA Regulated manufacturing processes, process validation, computer and equipment validation, and GMPs. Utilizes established protocols to perform validation and qualification tests and provide detailed and accurate analysis of test results, identifying validation failures and ...

Develops validation/qualification deliverables such as Validation Plans. Supports the execution of equipment qualifications and validation protocols. Supports equipment qualification and validation activities.

Must feel comfortable wearing multiple hats, from helping to design and implement new SW modules for validation, to leading the debugging of a HW issue in the lab, putting together a validation schedule; and anything in-between. Interface with multiple functional teams within ZT as well as with c...

Oversees findings follow up and issue validation. Regulatory Finding Validation experience.