Commissioning and Qualification (CQV) Engineer

IQ, OQ, PQ, Validation, Commissioning, Qualification, Equipment, HVAC
Contract W2, Contract Corp-To-Corp, 6 Months
Depends on Experience
Work from home available

Job Description

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.

 

Dice Id : pyrmid
Position Id : 20-26168
Originally Posted : 1 year ago
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