Sr. CQV Specialist - 174084 - 174788

ZP Group; Raritan (NJ); In loco; USD 76.000 - 83.000; Part-time

Vantaggi offerti da questo lavoro

Medical insurance

Dental insurance

Vision insurance

401K

PTO

Sick leave

Paid holidays

Descrizione del lavoro

Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturing organization in Raritan, NJ.

The Sr CQV Specialist will play a key role in maintaining compliant manufacturing operations, supporting audits and investigations, and mentoring junior engineers in a fast-paced environment where each batch directly impacts a patient.

Competenze

• Bachelor’s degree in Science, Engineering, or a related technical discipline.
• 8+ years of CQV experience within pharmaceutical, biotech, biologics, or cell therapy manufacturing environments.
• Strong knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle principles.
• Experience with investigations, CAPAs, change controls, and remediation activities.
• Familiarity with Kneat, Maximo, Siemens EMS, Comet, Kaye AVS, and Kaye ValProbe preferred.
• Ability to work independently, manage shifting priorities, and mentor junior engineers.
• Strong communication skills with experience supporting audits and inspections.

Mansioni

• Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and processes.
• Author and execute CQV protocols, reports, and associated documentation ensuring compliance and data integrity.
• Lead or support deviations, investigations, CAPAs, corrections, and remediation efforts.
• Manage multiple CQV projects while collaborating with cross-functional teams and vendors.
• Support change controls, risk assessments, FMEAs, periodic reviews, and validation lifecycle activities.
• Present CQV activities during regulatory inspections and internal audits.
• Train and mentor junior team members on CQV processes and best practices.

Conoscenze

CQV experience

cGMP knowledge

Audit support

Mentoring

Formazione

Bachelor’s degree in Science/Engineering

Strumenti

Kneat

Maximo

Siemens EMS

Comet

Kaye AVS

Kaye ValProbe

Descrizione del lavoro

Piper Companies is seeking a Sr CQV Specialist to support commissioning, qualification, and validation activities for a leading cell therapy manufacturing organization in Raritan, NJ. The Sr CQV Specialist will play a key role in maintaining compliant manufacturing operations, supporting audits and investigations, and mentoring junior engineers in a fast-paced environment where each batch directly impacts a patient.

Responsibilities of the Sr CQV Specialist

• Execute commissioning, qualification, requalification, and validation activities for facilities, equipment, utilities, and processes
• Author and execute CQV protocols, reports, and associated documentation ensuring compliance and data integrity
• Lead or support deviations, investigations, CAPAs, corrections, and remediation efforts
• Manage multiple CQV projects while collaborating with cross-functional teams and vendors
• Support change controls, risk assessments, FMEAs, periodic reviews, and validation lifecycle activities
• Present CQV activities during regulatory inspections and internal audits
• Train and mentor junior team members on CQV processes and best practices

Qualifications of the Sr CQV Specialist

• Bachelor’s degree in Science, Engineering, or a related technical discipline
• 8+ years of CQV experience within pharmaceutical, biotech, biologics, or cell therapy manufacturing environments
• Strong knowledge of cGMP, cGTP, FDA/EU regulations, and validation lifecycle principles
• Experience with investigations, CAPAs, change controls, and remediation activities
• Familiarity with Kneat, Maximo, Siemens EMS, Comet, Kaye AVS, and Kaye ValProbe preferred
• Ability to work independently, manage shifting priorities, and mentor junior engineers
• Strong communication skills with experience supporting audits and inspections

Compensation for the Sr CQV Specialist includes

• Salary range: $55-60/hr
• 6-month contract opportunity with the potential for extension
• Comprehensive Benefits: Medical, Dental, Vision, 401K, PTO, Sick Leave (as required by law), and Paid Holidays