Sunrise Systems Looking for Commissioning/Qualification Specialist/Validation at Warren, NJ  Full Time

• Intermediate knowledge of cGMP pertaining pharmaceutical facilities, utilities, and equipment.
• Intermediate knowledge of pharmaceutical manufacturing and utilities that support cell therapy clinical manufacturing.

 
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 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.
• 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 RESPONSIBILITIES
 
1) Commissioning and Qualification:
 

1. Administer change control activities and corrective and preventive actions.
2. Review, approve, and execute test protocols, validation deliverables, and plans as needed.
3. Author, review, and approve SOPs, work practices, and other procedural documents.
4. Provide input and guidance for change strategy, risk assessment, testing and compliance gaps.
5. Serve as an SME for change controls, investigations, CAPAs, and audits, as applicable.

 
2) Promotes and provides excellent customer service and support:
 

1. Regularly reviews, prioritizes, and promptly responds to customer equipment qualification and support requests.
2. Provides technical support and guidance on equipment commissioning and qualification. Interfaces with customers to ensure all expectations are met.
3. 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:
 

1. Ensures timely completion of equipment commissioning and qualification projects, individually and/or with
2. support of contracted personnel.
3. Develops an effective mechanism for communicating the current status of all manufacturing and laboratory
4. equipment to affected stakeholders.
5. Continually seeks opportunities to increase internal client satisfaction and deepen client relationships.

 
4) Regulatory Responsibilities:
 

1. Ensures manufacturing and laboratory facilities and utilities are maintained in compliance with GMP and other Client standards and regulations.
2. 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 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; PREFERRED – 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/or 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.
 
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.

 
Contact:
V R Manjunathan | Direct: (732)-860-1831 | Email: [email protected]| URL: www.sunrisesys.com