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Validation Enginer

Company Name:
Human Capital Resource LLC
Validation Engineer
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 companys 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 SOPs, Functional specifications, test plans, technical and summary reports.
Maintains an updated Master Validation Plan and other technical
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&IDs 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 cGMPs, 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 abilities
Ability to multi-task and quickly adapt to changes.
Must be detail-oriented, have strong analytical and troubleshooting skills, strong communication and documentation skills
Interpersonal skills: telephone skills, communication skills, active listening and customer-care
Excellent written and verbal communication and interpersonal skills.

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