Senior Validation Specialist Jobs

Participate in the CQV of process/FUE and cleaning validation.

Using the process automation system for the commissioning and validation of process equipment.

Protocol Development (IQ,OQ, PQ) / protocol review for process equipment/FUE and/or cleaning validation.

Interface with client personnel and with outside vendors when necessary while performing the above.

If you'd like to find out about this opportunity, please forward your CV to Nelson Anthony ([email protected]).

Create and maintain Benefit’s packaging material restriction list; alert packaging engineers if a package under development does not meet restrictions

1- 3 years of Experience in Packaging Development

Knowledge of cosmetic packaging materials & development

Knowledge of package safety tests

Maintain packaging material database and perform country specific import quantity calculations as needed for global reporting.

Complete country specific packaging material reporting to authorities as required to ensure company compliance to applicable packaging regulatory/environmental legislations globally.

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

Participate in the CQV of process/FUE and cleaning validation.

Using the process automation system for the commissioning and validation of process equipment.

Protocol Development (IQ,OQ, PQ) / protocol review for process equipment/FUE and/or cleaning validation.

Interface with client personnel and with outside vendors when necessary while performing the above.

If you'd like to find out about this opportunity, please forward your CV to Nelson Anthony ([email protected]).

Minimum of (5 – 8) five to eight years working experience in risk management in the Energy industry

Inventory of Models used within the Risk Management Function (RMF) and without as requested

Candidate must have general knowledge of energy markets, natural gas, power, oil crude & products, LNG and Freight

Excellent critical thinking and problem-solving skills

Strong analytical skills with attention to detailed data analysis and complex model configuration

Ability to multi-task and accommodate organic changes in requirements for deliverables

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

Experience in the management and conduct of Validation activities as part of either a program or development program.

Self- starter with initiative and proven management skills

Tertiary degree in Aviation (Management), Engineering or equivalent experience.

Engage with Wisk partners (Boeing) to align FAA and Boeing initiatives to Wisk operational requirements.

5+ years experience in a Part 135 Airline. (Flight Operations / Dispatch)

Demonstrated experience with Autonomous aircraft

Managing equipment induction activities including selection, procurement, qualification, and CSV

Reviewing and approving vendor-supplied qualification documentation

Maintaining current and accurate inventories of all equipment and software versions, including qualification status

Minimum of 2 years of experience in managing equipment commissioning, including CSV

Experience in assay method validations

Minimum of 5 years of experience in a quality role, preferably in a GLP environment

· Knowledge in working with current issue and effect management software

· Knowledge of risk/hazard analysis of business requirements leveraging GAMP 5

· Develops manual test cases with associated test runs using requirement and functional specification documents

· Knowledge of performing validation of BECS Software and Standard Operating Procedures

· Knowledge of FDA and international medical device regulations

· Prefer knowledge and understanding of applicable Regulated Software Application (RSA) modules

Demonstrates strong client service skills, teamwork, and collaboration.

Strong computer, scientific, and organizational skills

A combination of college and related technical experience will be considered (e.g., 14+ years’ experience)

Three years of regulatory experience including quality system/program development

Validation Specialist responsibilities include, but are not limited to, the following

Benefits & Perks To Foster Work/Life Balance

Strong understanding and experience with Aseptic techniques, cell manufacture processes and technologies preferred

Review of Validation protocol related data evidence

Review of CSV related data evidence

Review of QC related data evidence

Review of Tech Transfer related data evidence

Compile, analyze qualification/validation data, and develop Trace Matrices (TM).

Manage multiple projects, ensuring effective customer communication.

Demonstrate excellent written, verbal, and presentation skills.

Assess project scope, manage change, and solve problems.

Bachelor’s degree in a scientific, technical, or engineering discipline with 5 to 7 years of experience working within an FDA-regulated environment.

Considerable knowledge of FDA regulations / cGMPs, and Good Automated Manufacturing Practices (GAMP).

Deep technical knowledge of Validation of equipment, facilities and utilities

Strong risk assessment understanding and experience writing those assessments.

Write and performs Equipment, Facility and Process Installation/Operational/Performance Qualifications (IQ/OQ/PQ).

Minimum 7 years experience in validation

Equipment, utilities and facilities validation experience required.

PMP experience is a plus

Experience in project management, test design, process flow, and troubleshooting.

5+ years relevant experience in validation and GMP.

Proficiency in manage multiple projects, setting priorities, and working in a fast-paced environment.

Experience using precision measuring instrument and electronic testing devices.

Excellent oral and written communication skills

Excellent organizational and interpersonal skills