Description: Positions
Validation CQV Engineer
Summary
Val Source is currently looking to identify and hire Commissiong, Qualification & Validation (CQV) Engineer’s in our Empire Region (Albany, New York area). These candidates must have a minimum of 2 years’ experience or more working in the Pharmaceutical/Biopharma industry. Selected candidates will be full-time Val Source employees that will support a variety of different CQV projects with our clients throughout the Empire Region.
Responsibilities/Requirements

• Qualified Candidates will be responsible for the generation, execution and project deliverables related to CQV in pharmaceutical, biotech and ATMP facilities including laboratory and manufacturing equipment and processes as applicable. Responsibilities for this scope of work include but not limited to the following:
• Perform validation activities for Syringe Assembly Machines, including installation, operational, and performance qualification (IQ, OQ, PQ).
• Develop, review, and execute validation protocols and reports in compliance with GMP standards.
• Troubleshoot and resolve equipment-related issues during validation activities.
• Collaborate with cross-functional teams, including Engineering, Quality Assurance, and Manufacturing, to ensure successful validation.
• Maintain detailed and accurate documentation in accordance with regulatory requirements.
• Support continuous improvement initiatives to optimize equipment performance and compliance.
• Understand risk assessments, impact assessments, and system boundaries.
• Interface with your project manager (PM) and understand your responsibility on the CQV of utility, facility, and process equipment.
• Must be able to work independently or in a team environment, interacting with individuals at all levels in an organization and departmental areas.
• Preparation and turnover of your timesheets promptly for project manager/client review.
• Review of ETOP’s.
• Possess a strong understanding of and the ability to generate documentation associated with projects, including but not limited to: Standard Operating Procedures (SOPs), Design Qualifications (DQ), Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), Installation Verification (IV), Operation Verification (OV), Commissioning (COM), Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Alarm Criticality Assessment (ACA), Data Integrity Assessment (DIA), System Impact Assessment (SIA), and System Requirement Assessment (SRA).
• Strong organizational, excellent writing and communications skills.
• Knowledge of Industry guidelines (ISPE, PDA), US and international regulations (FDA, ICH, ISO, EU) for validation of GMP facilities.
• Proficiency with Microsoft office including Word, Excel, and Power Point. Microsoft Project and Visio a plus.
• Qualified candidates must have some experience with the following equipment or systems:
• Syringe Assembly Machines.
• Filling Machines.
• Cleaning Systems (CIP/SIP).
• Bio/Pharma process manufacturing equipment.
• Bio/Pharma laboratory equipment (Micro & Analytical).

Requirements:

Location/Travel Potential
Currently we are looking to identify local CQV Engineer’s in our Empire Region to support our Commissioning Qualification and Validation projects project at our client sites. It is our goal to assign people to projects that are within a commutable distance from their home. This allows Val Source to be more cost competitive, saves money for our clients and minimizes the travel burden on our employees. While we will try to adhere to this philosophy, you may be required to travel for a portion of your projects. Expenses incurred for travel-related assignments will be reimbursed in accordance with our travel policy.
About Val Source
Val Source is one of the largest independent validation services companies in North America with over 350 full time Engineering, Commissioning, Qualification and Validation employees. Val Source returns validation to a scientific event which helps companies design, perform and better control manufacturing processes throughout all stages of the operations life cycle. Full-time employees are offered a competitive compensation package that also includes full benefits (100% employer paid medical, dental, vision, short- and long-term disability), 401k, paid time off (holidays and vacation), continuous training and development, Employee Stock Ownership Plan (ESOP), discretionary bonus, etc.
Authorization
In compliance with federal law, all persons hired will be requi red to verify identity and eligibility to work in the United States up hiring/onboarding. Val Source participates in E-Verify and will provide the Federal Government with your Form I-9 information to confirm that you are authorized to work in the United States.
Equal Employment Opportunity
Val Source provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, genetic information, military, and veteran status.