Omni Inclusive
Commissioning/Qualification Specialist/Validation
Omni Inclusive, Warren, New Jersey, us, 07059
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 clinicalmanufacturing.• REQUIRED: Intermediate knowledge of commissioning and qualification of clean manufacturing facilities,material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.• PREFERRED: 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 afast-paced environment and concurrently monitor tasks and assignments with others that may impact timelycompletion. Ability to effectively manage multiple tasks and activities simultaneously.• High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn newsoftware, such as corporate intranet and enterprise business.• Working knowledge of scheduling software and systems, and inventory management systems.• Ability to create and analyze meaningful metrics.
Competencies:• Professional Knowledge• Problem Solving• Team Player / Building Relationships• Multi-tasking• Customer Focus• Action and detail oriented• Active Listening• Decisive
DUTIES AND RESPONSIBILITIES1) 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 withcustomers to ensure all expectations are met.c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualificationdepartment 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 withsupport of contracted personnel.b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratoryequipment 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 otherClient standards and regulations.b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.
4. EDUCATION AND EXPERIENCE:• BS in Engineering required. Must be able to read and understand construction and mechanical drawings andP&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; PREFERRED - liquid nitrogen supply systems, DIWater.• 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 workindependently.• Experience interacting with external and/or internal auditors in a compliance audit environment with directinteraction 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 individualinitiative, accountability to the team, and professional maturity are required.
PHYSICAL / MENTAL DEMANDS: (US Only)• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs.• 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.
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 clinicalmanufacturing.• REQUIRED: Intermediate knowledge of commissioning and qualification of clean manufacturing facilities,material pass-throughs, AHUs, compressed air, carbon dioxide, and process air systems.• PREFERRED: 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 afast-paced environment and concurrently monitor tasks and assignments with others that may impact timelycompletion. Ability to effectively manage multiple tasks and activities simultaneously.• High proficiency in Microsoft Office Suite - Word, Excel, PowerPoint and Outlook. Innate ability to learn newsoftware, such as corporate intranet and enterprise business.• Working knowledge of scheduling software and systems, and inventory management systems.• Ability to create and analyze meaningful metrics.
Competencies:• Professional Knowledge• Problem Solving• Team Player / Building Relationships• Multi-tasking• Customer Focus• Action and detail oriented• Active Listening• Decisive
DUTIES AND RESPONSIBILITIES1) 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 withcustomers to ensure all expectations are met.c. Maintains a positive relationship with all the members of the Equipment Commissioning & Qualificationdepartment 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 withsupport of contracted personnel.b. Develops an effective mechanism for communicating the current status of all manufacturing and laboratoryequipment 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 otherClient standards and regulations.b. Acts as equipment commissioning and qualification SME in internal and regulatory audits.
4. EDUCATION AND EXPERIENCE:• BS in Engineering required. Must be able to read and understand construction and mechanical drawings andP&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; PREFERRED - liquid nitrogen supply systems, DIWater.• 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 workindependently.• Experience interacting with external and/or internal auditors in a compliance audit environment with directinteraction 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 individualinitiative, accountability to the team, and professional maturity are required.
PHYSICAL / MENTAL DEMANDS: (US Only)• Occasional stooping, bending, stretching, pushing, pulling, reaching and/or lifting up to 25 lbs.• 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.