Validation Engineer (CQV)

Job Title : Validation Engineer (CQV)

Location : Pennsylvania (Onsite)

Experience : 4 - 5 Years

Employment Type : 12+ months

We are seeking skilled Validation (CQV) Engineers to support a variety of Commissioning, Qualification, Validation, and Process Engineering projects. This role is ideal for engineers experienced in pharmaceutical or biotech GMP environments who are hands-on, detail-oriented, and ready to take ownership of technical project execution.

Key Responsibilities

Execute and support commissioning, qualification, and validation activities for GMP manufacturing systems and equipment.

Conduct Risk Assessments and Impact Assessments , defining system boundaries and validation approaches.

Prepare, review, and execute protocols for DQ, FAT, SAT, IQ, OQ, and PQ .

Develop and review Standard Operating Procedures (SOPs) , ETOPs, and other controlled documentation.

Perform cleaning and sterilization validation for manufacturing equipment.

Support validation of utilities, process systems, laboratory systems, and temperature mapping .

Investigate, troubleshoot, and resolve discrepancies and deviations , ensuring timely closeout.

Collaborate with clients and internal teams on technical issues, project schedules, and budgets.

Participate in client meetings and manage assigned tasks to ensure project deliverables are met on time and within scope.

Requirements

Bachelor's degree in Engineering, Life Sciences, or related field.

2 5+ years of experience in CQV within Pharmaceutical, Biotech, or Medical Device GMP environments.

Strong understanding of GMP, ISPE, PDA, FDA, ICH, ISO, and EU validation standards and guidelines.

Excellent technical writing, organizational, and communication skills .

Ability to work independently or collaboratively in fast-paced, changing environments.

Proficiency in Microsoft Word, Excel, PowerPoint ; experience with MS Project or Visio is a plus.

Prior hands-on experience in Process Engineering, Facilities, or Operations within GMP environments is highly desirable.

Systems & Equipment Exposure

Process and packaging equipment

Critical and non-critical utilities (WFI, clean steam, HVAC, compressed gases)

Automation and control systems

Cleaning systems / processes and laboratory equipment