Validation Engineer

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Position Description, Functions, Duties and Tasks :

The Validation Engineer leads validation efforts associated with the operation of the site. Primary areas of focus includes equipment qualification, process & cleaning validation, commissioning activities, computer system validations and ad hoc projects as business needs.

Develop, write, review and execute validation protocols and reports, risk assessments, SOP's, validation plan for individual projects, URS, commissioning and decomissioning documents, installation, operation and performance qualification protocols and reports.

Leads validation work arising from change controls, capital projects, shutdown and also ongoing revalidation programs as necessary to ensure appropriate document lifecycle. Background in root cause analysis, OOS investigations and CAPA.

Provide validation subject matter expertise to multi-function teams, advises operations on validation matters, and participate in regulatory audits as validation SME.

Analyze data generated during validation and determine suitability and quality attributes.

Initiate, investigate and report on validation discrepancies and deviations.

Train other personnel to assist in the execution of validation activities; provide oversight during execution.

Coordinate validation execution with various units including process engineers, validation specialist, quality control and operations.

Prepare / Review site quarterly and annual product quality review using statistics methods.

Minimum Qualification (Education, Experience and / or Training, Required Certifications) : Education :

BA / BS degree in Engineering (ME, EE, or Chem. E), related physical science or equivalent work experience required.

Experience :

Minimum Of Three Years Pharmaceutical / Biomedical / Biotechnology Manufacturing Experience

Two years previous process, equipment and facility validation experience.

Additional Preferences :

Special Skills :

Ability to demonstrate flexibility to meet business needs / priorities

Strong computer skills are essential including Word, Excel, and PowerPoint, Good interpersonal skills, teamwork, planning, organization and prioritizing are essential.

Expertise strongly desired in the following areas : IQ, OQ and PQ URS, Commissioning Statistics

Working knowledge of cGMPs, product lifecycle and validation regulatory requirements / guidelines understanding strongly desired.

Excellent technical writing skills.

Working knowledge of statistical process control tools (such as Six Sigma) desired.

Ability to participate in and execute risk based decisions.

Good interpersonal, verbal communication, writing skills.

Must be able to multitask, have initiative and set priorities.

What do we offer?

Competitive Salary

Competitive Benefits Package and Employee Assistance Program

401(k) Plan + Company Match

Vacation + End of Year Vacation (Company Sponsored)

Growth Opportunities to expand your career

Seniority level

Seniority level

Mid-Senior level

Employment type

Employment type

Full-time

Job function

Job function

Quality Assurance

Industries

Biotechnology

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