Qualification Specialist

3 weeks ago

Warren, United States Cynet Systems Full time
Job Description:

Pay Range $52hr - $55hr

Responsibilities:
  • Commissioning and Qualification:
  • dminister change control activities and corrective and preventive actions.
  • Review, approve, and execute test protocols, validation deliverables, and plans as needed.
  • uthor, review, and approve SOPs, work practices, and other procedural documents.
  • Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
  • Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
  • Promotes and Provides Excellent Customer Service and Support:
  • Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
  • Provides technical support and guidance on equipment commissioning and qualification.
  • Interfaces with customers to ensure all expectations are met.
  • Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification department and site customers while promoting a positive team environment.
  • Communication and Management of Timelines:
  • Ensures timely completion of equipment commissioning and qualification projects, individually and/or with support of contracted personnel.
  • Develops an effective mechanism for communicating the current status of all manufacturing and laboratory equipment to affected stakeholders.
  • Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
  • Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other Company standards and regulations.
  • cts as equipment commissioning and qualification SME in internal and regulatory audits.
Education and Experience:
  • BS in Engineering required. Must be able to read and understand construction and mechanical drawings and P&IDs.
  • Minimum of 3 years of experience in FDA-regulated industry.
  • Minimum of 3 years of experience developing and execution facility and utility qualification.
  • Strong background and experience in laboratory and manufacturing operations.
  • Knowledge of cGMP in the pharmaceutical industry.
  • Thorough knowledge and hands-on experience in commissioning and qualification of manufacturing facilities: REQUIRED - manufacturing rooms, material path-throughs.
  • Thorough knowledge and hands-on experience in commissioning and qualification of common utilities: REQUIRED - compressed air, carbon dioxide, process air, AHUs.
  • Liquid nitrogen supply systems, DI Water.
  • Thorough knowledge and hands-on experience with airflow visualization (smoke studies).
  • Strong computer skills, knowledge of calibration management and environmental monitoring systems preferred.
  • Strong problem-solving skills, strong verbal and written communication skills, and the ability to work independently.
  • Experience interacting with external and internal auditors in a compliance audit environment with direct interaction including face to face interaction and response to audit questions is preferred.
  • Strong interpersonal and communication skills, a team player willing to work in an environment where individual initiative, accountability to the team, and professional maturity are required.
Knowledge, Skills, and Abilities:
  • Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.
  • Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.
  • Intermediate knowledge of commissioning and qualification of clean manufacturing facilities, material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.
  • Commissioning and qualification of liquid nitrogen supply systems, DI Water, autoclaves, isolators, filling and capping equipment, and airflow visualization studies.
  • Understanding of scheduling and execution fundamentals.
  • Strong written and verbal communication skills.
  • Excellent interpersonal skills with experience dealing with a diverse workforce.
  • Strong multi-tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a fast-paced environment and concurrently monitor tasks and assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities simultaneously.
  • High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn new software, such as corporate intranet and enterprise business.
  • Working knowledge of scheduling software and systems, and inventory management systems.
  • bility to create and analyze meaningful metrics.
Competencies:
  • Professional Knowledge.
  • Problem Solving.
  • Team Player / Building Relationships.
  • Multi-tasking.
  • Customer Focus.
  • ction and detail oriented.
  • ctive Listening.
  • Decisive.
Physical Requirements (Due to the nature of the job):
  • the candidate should be able to lift 25 pounds with assistance.
  • bility to sit, stand, walk and move within workspace for extended periods.
  • bility to perform repetitive tasks including hand to finger manipulations, grasping, pushing and pulling.

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