Senior Validation Manager
2 weeks ago
The Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ. Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you will define, implement and maintain the validation program for the site, ensuring compliance to the company quality guideline, FDA regulatory requirements, and cGMP regulations.
RESPONSIBILITIES
- The ideal candidate will have strong understanding of risk-based approach to validation, related to aseptic process and environmental control and extended experience with risk assessment including FMEA and AMDEC.
- Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
- Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
- Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality team.
- Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
- The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
- Lead the overall validation strategies and validation master plans.
- Compile validation packages and ensure all required documentation is complete.
- Responsible for the implementation and execution of the periodic system reviews and requalification activities.
- Lead investigation related to deviations and discrepancies with impact on validation.
- Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
- Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
- Assist in presentation of validation packages during inspections or audits.
- Participate, as required, in the response to regulatory audit observations.
- Recognizes potential safety and compliance problems and takes actions to rectify them.
QUALIFICATIONS
- Bachelor’s degree in Engineering, Science, or related technical field.
- Minimum 10 years applicable experience of CQV activities in a cGMP manufacturing environment and on aseptic processes.
- Expert in Quality Risk Management (Performing Risk assessments and using results for determination of test strategies).
- Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) related to validation in a cGMP facility.
- Experience using statistical, risk assessment, and process improvement tools.
- Familiarity with validation tools and processes, including environmental mapping and use of Kaye Validator.
- Ability to plan and execute Smoke / Airflow Visualization Studies.
- Ability to recommend, judge, and make good decisions in complex situations.
- Strong organizational skills, excellent writing, and communications skills. Must be able to work independently and in a team environment, interacting with individuals at all levels in an organization and departmental areas.
- Lead all validation activities in a hands-on approach and in collaboration with the engineering and Quality teams.
- Manage multiple validation projects simultaneously, plan, coordinate and track the progress of the work.
- The role includes writing, reviewing and coordinating documents required for Commissioning/Qualification/Validation such as but not limited to URS, Risk Assessment, System impact assessment, Validation master plan, in a cGMP manufacturing environment.
- Lead the overall validation strategies and validation master plans.
- Compile validation packages and ensure all required documentation is complete.
- Responsible for the implementation and execution of the periodic system reviews and requalification activities.
- Lead investigation related to deviations and discrepancies with impact on validation.
- Assess impact to validated status of new systems and changes to existing systems using a quality risk-based approach.
- Develop and maintain CQV SOPs related to equipment, facility, and computerized systems.
- Assist in presentation of validation packages during inspections or audits. Participate, as required, in the response to regulatory audit observations.
- Recognizes potential safety and compliance problems and takes actions to rectify them.
Powered by JazzHR
kattcuw5Sf
-
Senior Validation Manager
2 weeks ago
Princeton, United States Catapult Full timeThe Senior Validation Manager is leading the site validation program and all qualification and validation activities at the Erytech, Princeton site, NJ. Validation activities include Facility/Clean rooms, manufacturing equipment, laboratory instrument, computer system, cleaning, and manufacturing processes in an aseptic environment. In this role, you will...
-
Senior Manager, Parking and Transportation
2 weeks ago
Princeton, United States Black Women Connect Full time**Location:** Princeton, NJ United States Job Title: Senior Manager, Parking and Transportation **Position Type:** Full Time **Post Date:** 02/22/2022 **Expire Date:** 04/22/2022 **Job Categories:** Medical Job Description **Senior Manager, Parking and Transportation** The Department of Public Safety, Security, and Transportation has an exciting opportunity...
-
Senior Manager, Safety Operations
1 week ago
Princeton, United States CareerBuilder Full timeThe Genmab Vacancy Website is hosted by our Global HR System vendor, Workday. If you have any questions related to the hosting of this site please contact us at Workday@Genmab.com . Senior Manager, Safety Operations & DM page is loaded Senior Manager, Safety Operations & DM Apply locations Japan time type Full time posted on Posted 30+ Days Ago job...
-
Senior bridge manager
2 weeks ago
Princeton, United States CareerBuilder Full timeRole: Senior bridge manager position Location: Phoenix, AZ Duration: Long Term Contract (C2C/W2) Job function roles: Bridge, Scribe and Communications Management Enterprise Major Incident Management (EMIM): The mission of Enterprise Major Incident Management (EMIM) is to prevent disruptions and significantly reduce impacts to our customers. EMIM drives...
-
Senior Marketing Sciences Manager
22 hours ago
Princeton, United States dsm-firmenich Full timeSenior Marketing Sciences ManagerPrinceton, NJHybrid The primary mission of Scent Unit Strategic Insights Director, Global is to develop, lead and align Consumer Insights, sensory and neuroscience methods for Home Scent/Air Care globally. The secondary mission is to expand and roll out Strategic Consumer Understanding for Fine Fragrance, working closely with...
-
Senior Product Manager
Found in: Appcast Linkedin GBL C2 - 5 days ago
Princeton, United States Fraser Dove International Full timeFraser Dove International is partnering exclusively with a growing pharmaceutical organisation. Discover more about our Product Marketing Manager opportunity; its objectives, duties/responsibilities, and the skills, experience, and competencies needed to succeed.Join our client's Marketing Operations Team as a Senior Product Marketing Manager, where you'll...
-
Regulatory Operations Senior Manager
2 weeks ago
Princeton, United States CareerBuilder Full timeJob Description We are currently seeking a Senior Manager of Regulatory Operations. Within the role you will: * Develop and execute novel drug regulatory strategy * Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines * Establish sound regulatory advice/position on...
-
Senior Brand Manager, Oncology Marketing
Found in: Talent US C2 - 2 weeks ago
Princeton, United States SUN PHARMA Full timeSun Pharmaceuticals Industries Inc. is the fourth largest generic pharmaceutical company in the world, and rapidly building brand presence. We manufacture, market and distribute pharmaceuticals to the nation’s largest wholesalers, distributors, warehousing and non-warehousing chain drugstores as well as managed care providers. Our goal is to continue to...
-
Senior Accountant
2 weeks ago
Princeton, United States NJ CURE Full timeJob Description Job Description Senior Accountant Description CURE Auto Insurance is looking for a Senior Accountant to support the monthly/quarterly/annual financial close and financial reporting processes for a STAT basis insurance company and a GAAP basis management company. The Senior Accountant will focus primarily on financial reporting but will be...
-
Senior Engineering Project Manager
Found in: Appcast US C2 - 2 weeks ago
Princeton, United States Equiliem Full timeAs the Senior Project Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also be responsible for the design quality, delivery of contracted scope, and meeting project objectives, requirements,...
-
Senior Engineering Project Manager
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Princeton, United States Equiliem Full timeAs the Senior Project Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also be responsible for the design quality, delivery of contracted scope, and meeting project objectives, requirements,...
-
Senior Programming Associate
Found in: Talent US C2 - 3 weeks ago
Princeton, United States Genmab Full timeThe Role & DepartmentThe Senior Programming Associate / Programming Manager supports the development of new therapies by ensuring integrity, consistency, and adherence to standards of data and produces well-structured, high quality data summaries in tables, figures, and listings for decision making.The Senior Programming Associate / Programming Manager will...
-
Senior Engineering Project Manager
Found in: Appcast US C2 - 5 days ago
Princeton, United States Equiliem Full timeThis is not an IT role. A Licensed Professional Engineer (PE) is required.As the Senior Project Engineering Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also be responsible for the design quality,...
-
Senior Engineering Project Manager
Found in: Appcast Linkedin GBL C2 - 5 days ago
Princeton, United States Equiliem Full timeThis is not an IT role. A Licensed Professional Engineer (PE) is required.As the Senior Project Engineering Manager, you will serve as the technical lead for design execution of projects. You will oversee all project design activities and serve as the primary point of contact for the client on the project. You will also be responsible for the design quality,...
-
Senior Accountant
1 week ago
Princeton, United States NJ CURE Full timeJob DescriptionJob DescriptionREGISTER - CURE Auto Insurance Careers (candridsoftware.com)Senior AccountantDescriptionCURE Auto Insurance is looking for a Senior Accountant to support the monthly/quarterly/annual financial close and financial reporting processes for a STAT basis insurance company and a GAAP basis management company. The Senior Accountant...
-
Senior Director Project Management
1 week ago
Princeton, United States WIRB-Copernicus Group Full timeABOUT WCG: WCG's clinical solutions are built on a foundation of best-in-class clinical services companies. We deliver transformational solutions that stimulate growth, foster compliance, and maximize efficiency for those performing clinical trials. WCG is proud to serve individuals on the frontlines of science and medicine, and the organizations striving to...
-
Senior Associate Director
1 day ago
Princeton, United States Princeton University Full timeOperational leadership and management: Systematically assess, develop, enhance, and implement the necessary business practices, processes, systems, protocols, and standards to support staff, student and program alignment with the goals of the center Director, Associate, Information Technology, Leadership, Senior, Staff, Education
-
Manager, Us Warehouse and Logistics
2 days ago
Princeton, United States Genmab Full timeAt Genmab, we’re committed to building extra[not]ordinary futures together, by developing antibody products and pioneering, knock-your-socks-off therapies that change the lives of patients and the future of cancer treatment and serious diseases. From our people who are caring, candid, and impact-driven to our business, which is innovative and rooted in...
-
Manager, US Warehouse and Logistics
Found in: Talent US C2 - 3 days ago
Princeton, United States Genmab Full timeThe Role & DepartmentReporting to the Senior Director, Supply Chain, US Warehouse and Logistics, the Manager, US Warehouse and Logistics will oversee the 3PL warehouse operation and supports Genmab’s Qualification and Validation activities. This role works with Quality Assurance to maintain GXP compliance throughout the warehouse and distribution...
-
Senior Global Product Manager
3 weeks ago
Princeton, United States MRINetwork Jobs Full timeJob DescriptionJob DescriptionSenior Global Product ManagerProduct Category- Surgical Reconstruction, TTLocation- New JerseyESSENTIAL DUTIES AND RESPONSIBILITIESTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. Manages new product development marketing activities for specific products within the...