Oceanside, California, United States · On-site
$115k–$140k/yr
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North Americ…
Skills: CQV, Project management, Validation strategies, GMP compliance, URS development
Pomona, California, United States · On-site
$110k–$120k/yr
Our goal is to skyrocket our clients’ success, and you can be a part of our team’s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North Americ…
Skills: Quality assurance, Validation documentation, GMP compliance, IQ/OQ/PQ protocols, Risk assessments
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Analytical skills, Problem-solving, Interpersonal skills, Leadership, Teamwork
Remote OK
$20/hr–$23/hr
This is a remote position. PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all …
Skills: Validation engineering, System validation, Software testing, Technical writing, Regulatory compliance
Remote OK
$40/hr–$53/hr
This is a remote position. PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all …
Skills: SAP S/4HANA, Computer System Validation, CSV, Computer Software Assurance, CSA
Hybrid
$120k–$155k/yr
This is a remote position. PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all …
Skills: Packaging Engineering, Labeling Engineering, Medical Device Industry, Design Controls, ISO Standards
Minneapolis, Minnesota, United States · On-site
$90k–$105k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Cleaning Validation, CQV, Kneat, GMP Compliance, Swab Sampling
City of Industry, California, United States · Hybrid
$120k–$155k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Packaging Design, Labeling Compliance, Medical Device Regulations, FDA Regulations, ISO Standards
Calauan, Laguna, Philippines · Remote Solely
PSC Software, a division of PSC Biotech, is a leading provider of cutting-edge, cloud-based quality management and regulatory compliance solutions. Our software helps organizations streamline processes, ensure compliance…
Skills: UI Design, UX Design, Wireframing, Prototyping, Adobe Creative Suite
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Calibration, Metrology, Troubleshooting, Equipment Repair, cGMP
Durham, North Carolina, United States · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Project Management, Operational Readiness, Biopharma Manufacturing, Regulatory Compliance, Risk Management
Dallas, Texas, United States · On-site
$80k–$110k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Business Development, Consultative Selling, Account Management, Pipeline Management, CRM Discipline
Minneapolis, Minnesota, United States · On-site
$90k–$105k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Validation, CQV, KNEAT, cGMP, Risk Assessment
York, Pennsylvania, United States · Hybrid
$250k–$350k/yr
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Strategic Leadership, P&L Management, Service Delivery, Contract Governance, Commercial Negotiation
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Quality assurance, Quality control, Regulatory compliance, Validation, Sterile manufacturing
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Engineering documentation, Data collection, Troubleshooting, Maintenance, GMP compliance
Manatí · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Quality Assurance, GMP, FDA Regulations, EMA Regulations, ICH Guidelines
York, Pennsylvania, United States · On-site
BioTechnique is a sterile injectable full service CDMO providing cytotoxic and therapeutic sterile injectable fill-finish services. From IND applications through commercial scale production, we provide formulation and co…
Skills: Analytical Skills, Problem Solving, Interpersonal Skills, Communication, Teamwork
Durham, North Carolina, United States · On-site
PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requi…
Skills: Validation engineering, Commissioning, Qualification, Computer system validation, CSV
Melbourne, Victoria, Australia · On-site
We are looking for a Computer Systems Validation (CSV) Engineer to join our team on a 12-month contract. The CSV Engineer will be responsible for assisting in planning, writing, implementing, and reviewing validation pro…
Skills: Computer Systems Validation, Validation Protocols, IQ/OQ/PQ, RTM, Test Scripts
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The CQV Project Manager will lead and execute validation strategies for capital projects, including facility expansions and utility upgrades. They will manage the full CQV lifecycle while ensuring adherence to regulatory requirements and industry best practices.
Candidates must hold a bachelor's degree in an engineering discipline and possess at least 5 years of experience in end-to-end CQV activities for capital projects. Proven expertise in GMP-compliant pharmaceutical environments and strong project management skills are essential.
Trusted cloud software for efficient businesses.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers. To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
Trusted cloud software for efficient businesses.
PSC Software®, a division of PSC Biotech® Corporation, provides inspection management and enterprise quality management software solutions that enable businesses to safely and efficiently deliver their products to market. Applications developed by PSC Software® address the needs of organizations that must maintain compliance in regulated industries. Our principle is that software should be affordable and user-friendly in order to provide a competitive advantage to our customers. To learn more, visit www.pscsoftware.com.
Offices: 700 Corporate Center Dr, Pomona, CA 91768, US
