What are the responsibilities and job description for the Commissioning/Qualification Specialist/Validation position at Omni Inclusive?
Purpose and Scope :
This role supports the successful operation of facilities, laboratories, and business functions at multi-use sites through interaction with internal team members and peer-level customers as well as external service providers. The position focus is on providing technical expertise and decision making while ensuring end-to-end and timely completion of Facilities and Utilities commissioning and qualification and ongoing work activities of low to moderate complexity, individually and with support of others. The incumbent spends most of their time on individual work. The incumbent may recommend modifications to work processes or procedures to functional management that impact their immediate function or organizational unit. The incumbent in this role works with entry, junior, and experienced level professionals to accomplish daily tasks and short-term projects according to established policies and procedures
Required Competencies 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.
material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.
filling and capping equipment, and airflow visualization studies.
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.
software, such as corporate intranet and enterprise business.
Competencies :
DUTIES AND RESPONSIBILITIES
1) Commissioning and Qualification :
a. Administer change control activities and corrective and preventive actions.
b. Review, approve, and execute test protocols, validation deliverables, and plans as needed.
c. Author, review, and approve SOPs, work practices, and other procedural documents.
d. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
e. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.
2) Promotes and provides excellent customer service and support :
a. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
b. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with
customers to ensure all expectations are met.
c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualification
department and site customers while promoting a positive team environment.
3) Communication and Management of Timelines :
a. Ensures timely completion of equipment commissioning and qualification projects, individually and / or with
support of contracted personnel.
b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory
equipment to affected stakeholders.
c. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.
4) Regulatory Responsibilities :
a. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other
Client standards and regulations.
b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.
4. EDUCATION AND EXPERIENCE :
P&IDs.
Water.
independently.
interaction including face to face interaction and response to audit questions is preferred.
initiative, accountability to the team, and professional maturity are required.
PHYSICAL / MENTAL DEMANDS : (US Only)
