Validation Engineer

Company Name:
Select Family of Staffing Companies
Weekly paychecks Health Care Other Great Benefits
Essential Functions:
Function as the manufacturing lead for process validation and equipment.
Will support validation projects of all types for new and existing products, and provide direction with regard to regulatory compliance.
Reviews and approves change control documentation and ensures compliance to established procedures.
Analyzes data and identifies trends to improve quality and efficiency of manufacturing and quality systems.
Investigates system gaps and failures, and works with business partners to ensure successful resolution.
Maintains and promotes proactive inspection readiness and ensures consistency and compliance with the Quality System and regulatory compliance.
Participates in manufacturing investigations and both internal and external audits as necessary.
Routinely interacts with data management systems such as AMAP's, Document Management Systems (Matrix One), and Non-Conformance and CAPA tracking (Trackwise).
Responsible for conducting validation studies in accordance with current industry standards and guidelines for the qualification and validation of manufacturing systems and supporting processes. These activities include researching and developing qualification and validation protocols, execution of the studies, analysis of the resulting data and development of the final report. These activities are conducted in accordance with client policies and procedures related to Qualification and Validation activities.
Presents process validation documentation to FDA and other outside auditors and inspectors.
Conducts audits of all processes to ensure that they are in compliance with validated process controls.
When non-conformance processes are found, initiates corrective action and assesses the need for a risk analysis.
Responsible for completion of studies within validation project time lines. Assists in the development of the time lines and communicates project updates within the validation department.
Responsible for investigation and documentation of all validation related failures including determination of assignable cause. Determine impact of failures on validation study.
Responsible for coordinating validation projects using internal and external resources.
Duties include:
Participates in departmental meetings and cross functional team meetings as required.
Performs other validation associated activities as defined by Director and Manager.
Works with Process Engineers, Maintenance Technicians, and Manufacturing Supervisors to develop and document validation protocols (IQ, OQ, PQ) on new equipment and for revalidation of existing equipment and processes.
Determines need for revalidation when process changes are made or equipment relocated.
Develops process monitoring schemes and analyzes data for trending from validation process.
Complete all required training applicable to assigned position.
Additional duties as requested or required.
Reviewing validation protocols and reports in accordance with industry standards and FDA guidelines for the qualification and validation of manufacturing systems and supporting processes.
Assuring that studies are completed within validation project time lines.
Assisting in the development of the time lines and communicates project updates within the validation department.
BS degree in Engineering or other technical degree.
A minimum of 5 years experience, demonstrated leadership in complex investigations, project management, and cross-functional teams
A minimum of 3 years of relevant work experience in the Medical Device field is required. In addition, experience in related quality assurance, quality control or engineering function is preferred.
Strong written and verbal communication skills.
Process Excellence/Six Sigma, ASQ Quality Engineer or Quality Auditor, Lean or other relevant certifications is preferred.
Experience in a Medical Device or FDA related manufacturing facility.
Experience with Word, Excel and Access computer applications.
Strong interpersonal skills for interactions with other departments.
Highly motivated personally, self-starting.
Welding experience preferred.
Experience in development and execution of installation qualification, operating qualification, and process qualification (IQ, OQ, PQ) protocols for manufacturing processes.
Hours are M-F 7am-4pm or 8am-5pm
Salary ranges around $30/hour
Resumes can be emailed to us or call 216/372-5556 for more information.
Need flexibility in your work schedule?
Crave a high-pay, low-stress job opportunity?
Want someone to cut through the noise and find the ideal job for you?
Join the Select Staffing team, and we'll get you on a new career path. From helping you tune up your resume to accelerating your skills with our computer training, we'll get you on the road to professional success!
Potential Select benefits include health insurance, dependent care assistance accounts, referral bonuses, and safety incentives, as well as the best temporary, part-time, and full-time positions available in today's growing job market.
Select is proud to invite qualified job seekers to join our team of talented Associates. Please note our screening requirements before applying: All applicants must provide documentation proving that they are eligible to work in the United States and may be asked to submit to a drug test and reference and background checks.

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