Senior Validation Specialist
Newark Metro Area, NJ
The Senior Validation Specialist implements and maintains all validated equipment / systems in compliance with policies, guidelines and procedures. Through this work, the incumbent supports the successful operation of facility, laboratory and business functions at multi-use sites through interaction with internal customers and external service providers. The incumbent identifies issues or unmet needs and initiates projects or programs to address them. This individual works independently to complete assignments and oversees the successful completion of tasks. Using solid analytical skills, the incumbent is able to recognize problems of moderate scope and complexity, and independently develop potential solutions and courses of action. This individual represents the work group on multi-disciplinary and cross-functional teams and uses established relationships to influence and lead teams and stakeholders with fact-based, business value knowledge. The incumbent will be heavily involved with deviations, investigations and change controls.
Education & Experience:
- BS degree in Engineering, Biology, Chemistry, Computer Science, or equivalent
- 10 years of combined experience in FDA-regulated GMP lab environment, minimum 5 years in validation
- Must have experience validating and using common lab equipment and stand-alone computerized lab systems
- Must have experience and strong working knowledge of initiating, routing, implementing, and closing change controls, investigations, and CAPA using quality management systems software, such as eQRMS, TrackWise, or equivalent
- Must have experience and strong working knowledge of initiating, routing, editing, reviewing, and approving controlled documents using enterprise content management platforms, such as Documentum, VeevaVault, or equivalent
Required Competencies-Knowledge, Skills, and Abilities:
Knowledge, Skills & Abilities:
* IMPORTANT - Strong knowledge of cGXP requirements and good documentation practices relating to computerized systems, equipment, and instrumentation within the pharmaceutical industry
* Advanced knowledge of 21 CFR Part 11 compliance and data integrity requirements
* Strong knowledge and experience with the operation and qualification of pharmaceutical laboratory, facilities and manufacturing systems
* Strong experience writing and executing system validation & equipment qualification documents
* Ability to interact effectively with laboratory personnel, QA, and Facilities groups
* Maintains a high level of multi-tasking ability in conjunction with proven organizational skills. Strong ability to organize assigned tasks in a high paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously
* Strong written and excellent verbal communication skills along with excellent leadership skills that encourages empowerment and ownership within the team and organization. Extremely proficient at writing well-formulated emails and reports. Ability to follow oral and written instructions, read and interpret engineering manuals/drawings relevant to the assigned task. Ability to effectively communicate with employees, contractors and vendors. Strong experience with technical writing and document development / generation
* Innate ability to learn new software as required for equipment qualification and system validations.
* Expertise in the evaluation of new computerized systems in an effort to identify compliance gaps early on in the process and implement mitigations to ensure the highest quality standards are met.
Physical / Mental Demands:
* Occasional stooping, bending, stretching , pushing, pulling, reaching and/or lifting up to 50lbs
* Ability to sit, stand, walk and move within workspace for extended periods
* Ability to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling
* Ability to climb ladders and work in elevated areas.
* Ability to work extra hours on limited occasions in order to meet deadlines
* Minimal travel in North America
* Environment may include working in office or in a laboratory / manufacturing area.
* Ability to work safely in an environment with hazardous, radioactive, and infectious materials and waste.
* Ability to work safely in an environment with exposure to high temperature / pressure steam, compressed gasses, odors, various noise levels, moving parts, vibration, wet/slippery areas and high voltage energy supplies
* Environment may include working at heights, in cold temperatures, and/or constricted spaces
* Ability to work safely when working alone, or working with others.