Commissioning and Qualification (CQV) Engineer

Commissioning and Qualification (CQV) Engineer

Vacancy expired!

Immediate need for a Job title

Commissioning and Qualification (CQV) Engineer experience in the

Pharmaceutical Industry. This is

6+ Months Contract position with possible extension located in

Framingham, MA. Please review the job description below:

JOB ID # 20-26168

BSc/BEng plus previous experience in CQV field or equivalent combination of education and experience. Experience in pharmaceutical/biopharmaceutical industry or related industry/manufacturing environment. Areas of experience : clean utilities, HVAC, rooms/chambers, autoclaves, parts washers, environmental qualification, component prep equipment, computerized equipment etc,. Years of Experience: 4 - 9 Years

This individual assures validation activities are performed in conformance with applicable Standard Operating Procedures (SOPs), standards, industry best practices, and regulatory requirements. The individual performs validation program related activities such as: DQ, COM, IQ, OQ, PQ, CQ, RQ, etc.

Essential Duties and Responsibilities:
• Writes and executes commissioning, qualification, & validation protocols for facilities utilities, equipment, and computerized systems
• Writes final reports
• Resolves protocol discrepancies and deviations
• Reviews vendor generated validation protocol packages
• Supports change control deliverables
• Responsible for the generation of complex protocols using a risk based approach that meets current regulatory requirements and industry practices

Experience
• Minimum of 4 years of experience working in a cGMP regulated environment
• Minimum of 4 years of operational validation experience in a cGMP manufacturing environment
• Familiar with data logging systems (such as Kaye/Client Validator, ELAB, or Lives International)
• Basic knowledge of calibration activities, preventative maintenance, and cGMP quality systems preferred
• Practical knowledge of cGMP regulations required

Other Skills and Abilities:
• Excellent oral and written communication
• Ability to effectively manage time and prioritize tasks independently
• Excellent organizational skills
• Ability to manage day-to-day operations in a fast-paced environment
• Ability to effectively manage several tasks simultaneously
• Must be self-motivated and have a proven ability to work in a team environment
Our client is a leading

Pharmaceutical Organization and we are currently interviewing to fill this and other similar Contract positions. Qualified candidates should apply online for immediate consideration.