Validation Specialist

Job Description:

Position Summary: The Validation Specialist is primarily responsible for developing and executing validation protocols for new product development, sustaining, and quality system compliance activities for dental consumables. Additional responsibilities include the management of supplier qualification, approval, and monitoring, and supporting CAPA and Nonconformance investigations and corrective actions to resolve product and/or process issues.

Essential Duties and Responsibilities:

• Develop and execute validation protocols (IQ, OQ, PQ) for equipment, processes, and systems, including software.
• Prepare comprehensive validation reports and analyze and interpret validation data to identify trends, anomalies, and areas for improvement.
• Ensure validation activities comply with regulatory requirements and organizational/industry standards.
• Work closely and coordinate with QA, R&D, and Manufacturing Engineering Departments to plan and conduct the analysis, inspection, and test of products and/or processes to assure quality.
• Perform risk assessments and develop mitigation strategies related to validation activities.
• Review and approve validation deliverables from suppliers and third-party service providers.
• Participate in audits and inspections by regulatory agencies, notified bodies, and corporate internal auditors.
• Manage supplier quality activities by qualifying and approving suppliers, maintaining performance scorecards, and reviewing supplier corrective actions.
• Assist with investigation and root cause analysis of product and/or process issues in support of Nonconformance and CAPA quality compliance.
• Follow departmental Standard Operating Procedures and Work Instructions.

Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

Job Requirements:

Qualifications:  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. This individual must be able to function in a fast-paced environment, where priorities may change rapidly.  The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Minimum requirements:

• Bachelor’s degree plus a minimum of 2 years of relevant experience. We will also consider a High School diploma or equivalent plus 4 years of relevant work experience
• Experience conducting product and process validation; preferably in the Medical Device or Pharmaceutical industry.
• Ability to understand product applications, specifications, functionality, structure, assembly, and test methods/processes
• Proficient with Microsoft Office Suite including Word, Excel, and Outlook required.

Preferred requirements:

• Knowledge of FDA QSR, ISO 13485, and GMP regulatory requirements highly desired
• Knowledge of software validation practices for IT and automated systems is preferred
• Project management skills and the ability to manage multiple tasks simultaneously; ability to collaborate with other teams across the organization
• Strong technical writing skills and the ability to effectively communicate across all levels of the organization.
• Proficiency in statistical analysis and data interpretation.
• Ability to quickly learn computer business systems and software required (i.e. MasterControl, Oracle or other ERP is a plus, etc.)
• Effective verbal and written communication skills in English
• Ability to adapt to changing priorities in a fast-paced environment

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Employee is required to sit at a desk for long periods of time
• Frequently uses hands and fingers, occasionally reaches up/down with arms
• Position requires occasional standing and walking
• Position requires occasional bending and stooping
• The noise level in the environment is moderate
• PPE- Safety glasses required worn by all personnel in production areas or as indicated.

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Target Market Salary Range:

Actual compensation packages take into account a wide range of factors that are unique to each candidate, including but not limited to geographic location; skill sets; relevant education and certifications; depth of experience; performance; and other business and organizational needs. The disclosed reasonable estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled.  At Envista, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. The total compensation package for this position may also include an annual performance bonus, medical/dental/vision benefits, 401K match, and/or other applicable compensation plans.

$68,000 – $102,000

Operating Company:

Orascoptic

Envista and all Envista Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available at: http://www.dol.gov/ofccp/regs/ compliance/posters/pdf/eeopost.pdf.

Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate.  Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes.  An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening.  Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.