Pharmatek Consulting Inc.
Facilities/Utilities/HVAC Lead
Pharmatek Consulting Inc., New Brunswick, New Jersey, us, 08933
New Brunswick, United States | Posted on 10/02/2024
Industry Pharma/Biotech/Clinical Research
Job Type Contract
Work Experience 5+ years
State/Province New Jersey
Country United States
Job Description
We are looking for a CQV Lead withexpertise in production equipment such as isolators, bioreactors, fume hoods,BSCs, and TCUs. The candidate will be responsible for protocol development andexecution to ensure production equipment meets operational and regulatorystandards.
Key Responsibilities:
• Develop and execute commissioning, qualification, and validation protocols forproduction equipment.
• Coordinate with equipment vendors for FAT/SAT activities and ensure integrationinto facility systems.
• Oversee equipment calibration, performance verification, and documentation.
• Lead risk assessments to identify and mitigate potential equipment compliancerisks.
• Provide cross-functional support for other CQV efforts within the project. Requirements
Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in validating production equipment in pharmaceuticalenvironments.
• Expertise in isolators, bioreactors, fume hoods, and other lab equipment.
• Strong knowledge of regulatory requirements and risk-based validationapproaches.
• Excellent project management and problem-solving skills.
#J-18808-Ljbffr
We are looking for a CQV Lead withexpertise in production equipment such as isolators, bioreactors, fume hoods,BSCs, and TCUs. The candidate will be responsible for protocol development andexecution to ensure production equipment meets operational and regulatorystandards.
Key Responsibilities:
• Develop and execute commissioning, qualification, and validation protocols forproduction equipment.
• Coordinate with equipment vendors for FAT/SAT activities and ensure integrationinto facility systems.
• Oversee equipment calibration, performance verification, and documentation.
• Lead risk assessments to identify and mitigate potential equipment compliancerisks.
• Provide cross-functional support for other CQV efforts within the project. Requirements
Qualifications:
• Bachelor’s degree in Engineering, Life Sciences, or related field.
• 10+ years of experience in validating production equipment in pharmaceuticalenvironments.
• Expertise in isolators, bioreactors, fume hoods, and other lab equipment.
• Strong knowledge of regulatory requirements and risk-based validationapproaches.
• Excellent project management and problem-solving skills.
#J-18808-Ljbffr