POSITION SUMMARY

The Validation Engineer I will be responsible for ensuring that systems, including equipment, facility, utility, laboratory systems, and computerized systems are installed, operate, and perform as specified and are maintained through requalification and periodic reviews. This individual is responsible for writing, executing, and summarizing qualification and validation protocols, assisting in the development and maintenance of specification documents (URS/FRS/CS/DS), traceability matrices, data integrity assessments, and taking part in the development of validation plans.

EDUCATION AND EXPERIENCE

Bachelor’s degree, in a technical/science/mathematical field, preferred. 2+ years validation experience in a biotech/pharmaceutical environment. Strong experiences in areas such as manufacturing equipment qualification, facility and cleanroom qualification, utility qualification, laboratory instrument qualification, Process Validation, or computerized system validation. Experience with using common validation testing equipment such as Dataloggers, multi-meters, etc. Highly ethical and transparent, with professional sensitivity and care for confidentiality.

TECHNICAL SKILLS REQUIREMENTS / CORE COMPETENCIES

Strong written and oral communication skills with ability to interact with various individuals and roles throughout the organization and with external consultants. Technical writing background; able to read/analyze/interpret common scientific/technical documents. Results oriented, self-motivated, self-starter with flexibility to adapt to changing priorities and ability to manage 1-2 projects/activities simultaneously. Strong working knowledge of good documentation practices. Good interpersonal, organizational and trouble shooting skills. Strong ability and willingness to learn and work within a team environment. Highly ethical and transparent, with professional sensitivity and care for confidentiality. Excellent MS Office (Word, Microsoft Excel, and Power Point) skills.

PHYSICAL POSITION REQUIREMENTS

Requires the ability to follow proper gowning procedures and work in cleanrooms for uninterrupted periods of time of at least 4 hours. Requires the ability to sit or stand at a computer for long stretches of time and type. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside the office to access file cabinets and office equipment. May occasionally lift objects up to 20 pounds

• Supports activities related to qualification and validation for GMP manufacturing facility, operations, equipment, utilities, facilities, laboratory instruments, computerized systems, processes etc.
• Write, execute, and summarize qualification and validation protocols. Evaluate and analyze data for accuracy and sufficiency
• Assist in the development and revision of validation specifications and assessments.
• Assess equipment qualification documents and generate traceability matrices and data integrity assessments.
• Identify and document deviations noted during protocol execution
• Collaborates with project teams to support system implementation, upgrades, and provide technical input as needed
• Follow departmental and company-wide SOPs and policies, including SVMP
• Adheres to requalification and periodic review schedule for systems and processes per procedure and established plans; Analyzes and summarizes periodic reviews of previously validated systems, and develop/implement protocols/changes based on outcome of the review
• As needed, serve as the information resource for contractors and vendors hired to support validation activities
• Revise internal and external departmental procedures based on previously obtained data
• Participates with Validation team to establish the annual goals and desired culture
• Attend internal and external meetings to support validation topics
• Other duties as assigned by management