Validation Engineer II

Responsibilities

• Performs a variety of activities in support of equipment qualification and process validation including preparing and reviewing protocols and final reports, representing validation on project teams and preparing validation change control requests and revalidation assessments.
• Interfaces with peers in groups such as, Engineering, Process Development and Manufacturing to ensure that the design, implementation and qualification of equipment, systems and processes is conducted according to established quality standards through lifecycle management.
• Uses skills as a seasoned, experienced professional with a full understanding of industry practices and company policies and procedures.
• Resolves a wide range of issues in imaginative as well as practical ways
  Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Interacts with senior internal and external personnel.
• Provides general support to the organization to meet department goals and objectives.
• Participates on project teams requiring validation support.
• Provides training to company and contracted personnel on validation policies and procedures.
• Participates in the preparation or review of protocols and reports supporting the validation of equipment, systems and processes.
• Executes on validation protocols.
• Collects, compiles and reviews data in supports of validation studies.
• Supports validation change control activities and provides support for revalidation assessments of equipment, systems and processes.
• Receives minimal supervision on assigned tasks and projects.

• Requires a Bachelors degree in an engineering discipline. Equivalent experience may be accepted.
• A minimum of 5 years relevant work experience is required.
• A minimum of 2 years validation experience is required.
• Must be able to demonstrate knowledge of validation principles including user requirements, functional specifications, commissioning, IQ, OQ, PQ and process validation.
• A thorough knowledge of cGMP and regulatory requirements for validation is required.
• A working knowledge of utilities and general production systems used in non-sterile pharmaceutical manufacturing is required.
• Strong word processing and spreadsheet skills are required.
• Good communication skills both oral and written are required.
• Must be able to demonstrate excellent customer service skills.
• Strong attention to detail regarding documentation is a must.
• Must be well organized, and willing to work as part of a team.

• Must be able to pass pre-employment drug screening and background check for employment consideration.
• Employees must be able to lift or handle objects greater than 25 pounds to perform certain duties essential to the job function.
• Employees may be required to perform tasks essential to the job function in areas that require the use of hearing protection devices.
• Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function.