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Validation Engineer

We are one of the largest manufacturers of private label and contract products for various types of OTC Care, Personal Care & Home Care Products and associated chemicals.

We are currently hiring a Validation Engineer. Under minimal supervision from the QA Director, the Validation Engineer will lead, execute, implement, and assist with the daily CQV activities of the Validation Department.

The Validation Engineer will be responsible for the design, implementation and administration of the various IQ, OQ, PQ and CV protocols to meet pre-determined acceptance criteria. The Validation Engineer will also have the responsibility for V&V of critical utilities, USP water systems and software validation.

The validation Engineer must also be familiar with applied knowledge of statistical analysis. While performing all duties and responsibilities, the Validation Engineer, will, at all times, model corporate values and principles and act in a manner consistent with the company's Code of Business Conduct and Ethics.

 

Responsibilities:

  • Leads and executes CQV projects for new and legacy equipment. Has a full understanding of Commissioning,
  • Qualification and Validation to execute DQ/FAT/SAT/IQ/OQ/PQ/PV/CV and other validation life cycle documents.
  • Interfaces with Management personnel in Engineering, Manufacturing, Planning, Regulatory Affairs, and other technical disciplines to represent QA/Validation on project teams, with the objective to assure that project quality objectives are met.
  • Oversees quality assurance review and approval of Validation, Technical Services, Maintenance and
  • Engineering SOP's, Functional specifications, test plans, technical and summary reports.
  • Maintains an updated Master Validation Plan and other technical documentation
  • Has knowledge of Statistical plans, SPC and DOE application to validation of processes.
  • Has knowledge of CFR part 210 and 211 and cGMPs for finished pharmaceuticals, industry guidelines and best practices.
  • Familiar with chemical unit operations, USP water systems, P&ID's and isometrics
  • Conducts critical assessment and audits of all processes and equipment to identify areas of improvement
  • Performs documented risk assessment (gap analysis) and develops remediation plans in consultation with management, customers and regulatory agencies
  • Leads and mentors staff in a supervisory role.
  • Communicate the status of support request to users and management
  • Create, maintain and follow standards, policies and procedures
  • Other duties may be assigned by the direct supervisor.

Qualifications:

  • BS in Engineering or Life Sciences (MS preferred). Industry certifications a plus.
  • Minimum 5+ years' experience in an FDA regulated related environment
  • Strong working knowledge of cGMP’s, Pharmaceutical Quality Systems, ICH and FDA guidelines,
  • Strong technical knowledge of commissioning qualification and validation for process equipment, packaging lines, critical utilities, and support systems.
  • Technical awareness ability to match resources to technical issues appropriately
  • Proven analytical, evaluative and problem solving skills
  • Ability to multi task and quickly adapt to changes.
  • Must be detail oriented and have strong analytical and troubleshooting skills, strong communication and documentation skills.
  • Interpersonal skills consisting of telephone and communication skills active listening and customer care.
  • Excellent written and verbal communication skills.