Proclinical is currently recruiting for a Validation Specialist with a pharmaceutical company located in Memphis, TN.
- Responsible for helping to maintain the validation program including manufacturing, packaging, facilities, utilities, equipment, control systems, and processes at the Memphis facility. will generate validation documentation and plan validation projects.
- Effectively resolve issues associated with validation efforts and represent that department during internal audits.
- Responsible for the periodic trending of process capability data to ensure compliance with FDA standards.
- Develop, implement, and maintain a continuous verification program to include periodic trending of process capability data including all necessary procedures.
- Write and execute IQ, OQ, and PQ protocols and summary reports for the facilities/utilities, manufacturing, and packaging areas as needed.
- Write and execute PV protocols and summary reports for product reformulations and New Product Introductions (NPIs).
- Participates in Validation SOP development and the ongoing maintenance of the validated status of GXP systems.
- Responsible for driving all aspects of the Validation Life Cycle in Packaging and Utilities/Facilities from design through operation and improvement.
- Monitors validation criteria and assures compliance with written validation standards.
- Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation working party.
- Leads and ensures accountability to the site's Product Lifecycle Management governance process.
- Support site during internal audits as required.
- Comply with all local, state and federal EHS laws and regulations, and all Global EHS requirements.
Skills and Requirements:
- Bachelor of Science or Bachelor of Engineering
- Basic understanding of scientific or engineering discipline, validation or statistics
- 3-5 years of validation experience in pharmaceutical or consumer healthcare industry
- Successful demonstration of validation experience within a pharmaceutical or consumer healthcare manufacturing environment designated as new product introduction site with new products, processes, and equipment are being introduced continuously.
- Effective Strategic Communication skills -delivering written and oral communication with clarity and impact, tailored to the audience.
- Strategic Customer Focus- taking initiative (a clearly interconnected set of activities) designed to raise the 'value added' for to ensure a wider or long term effect/benefit.
If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.