Validation Engineer

*POSITION SUMMARY* This position is responsible for engineering functions within the Quality Dept.
The primary focuses are IQ OQ PQ activities and developing new strategies to exceed customer satisfaction.
Implements and coordinates project progress, IQ OQ PQ validations, and statistical data analysis.
Identifies and performs risk analysis to ensure inputs and outputs meet applicable medical validation and regulatory requirements.
Position will have a high focus on internal R&D, project development, IQ OQ PQ validation SOPs Work Instructions and document approval.
External focus is to ensure company success by identifying customer needs, customer expectations and meeting established completion dates.
*ESSENTIAL FUNCTIONS* 1.
Interface with all departments to define validation project scope, responsibility, accountability, actions/functions, timelines, and goals.
2.
Work closely with Quality and Regulatory Manager to develop project processes for IQ OQ PQ customer specific requirements, develop procedures, SOPs, protocols for project management.
3.
Develop and manage validation master list activities to support IQ OQ PQ validations and qualifications as required.
Prepare and perform process product qualifications as outlined in a customer specific validation protocol.
Ensures project development and IQ OQ PQ practices meet FDA/medical regulatory requirements.
4.
Work Instructions and IQ OQ PQ validation activities.
5.
Streamline and manage IQ OQ PQ project process steps to ensure they are clear and concise; report on validation status and work with all departments to achieve IQ OQ PQ validations continuous progress, meet deadlines and exceed customer satisfaction.
6.
Coordinate changes to IQ OQ PQ validation functions within all departments and customers.
7.
Create/Write and circulate all protocols, SOPs, and Work Instructions to responsible departments (including customers & suppliers) including routing management signature of approval.
8.
Provide input and output for validation testing to support product development; during R&D activities identify project risks that can affect form, fit, function and regulatory requirements for design, manufacturing, and quality.
9.
Interface with manufacturing department to provide documentation, statistical process, validation methodology, and services to meet customer and regulatory requirements as directed.
10.
Perform functions as directed to support quality management and company management team.
11.
Support R&D efforts in molding and secondary operations 12.
Work with R&D in transferring projects to manufacturing 13.
Designing and developing manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
14.
Providing production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.
15.
Generating and modifying manufacturing process documentation and assuring that manufacturing processes and related documentation follow established policies and procedures.
16.
Working with the Internal Audit team to perform annual schedule of quality system audits.
*Supervisory Responsibilities* May supervise indirect reports and contract associates as needed.
*POSITION QUALIFICATIONS* *Education and Experience* * A minimum of two-year degree in relevant field or equivalent required, with bachelor’s degree preferred, or applicable accredited certifications pertaining to job responsibilities.
* Minimum of three years of validation experience with IQ OQ PQ responsibilities preferably in a medical device (FDA21 CFR820 or ISO 13485:2016) environment.
Pharmaceutical (21 CFR 210-211) environment experience will be considered.
* Demonstrated knowledge of project coordination methodology and validation methods (IQ/OQ/PQ) statistical process control, application of statistical techniques, and meeting regulatory requirements per 21 CFR820/ISO 13485:2016.
* Experience with process capability statistics, AQL and background in medical device or pharmaceutical environment with FDA requirements strongly preferred.
* Ability to effectively use statistics associated with ensuring product coordination and IQ OQ PQ functions.
*Language Skills* Has strong written and verbal control of the English language, ability to communicate effectively with other departments and be clearly understood *Mathematical Skills* The ability to add, subtract, multiply, and divide all units of measure including whole numbers, common fractions, and decimals; the ability to compute rate, ratio, and percentages and develop and interpret graphs and statistics *Reasoning Ability* Has ability to solve practical problems and deal with a variety of concrete situations.
High level of attention to detail and accuracy required.
Ability to interpret a variety of inputs furnished in written, oral, diagram, or schedule form.
Exhibits strong judgment and works with minimal supervision *Computer Operations* Advanced personal computer skills including all Microsoft Office applications with background in ERP systems, Microsoft Project, or similar project software *Planning and Organization* Ability to effectively prioritize, organize, multi-task and be detailed oriented.
Good organization and communication skills.
Able to meet deadlines, follow through on commitments *Certificates, Licenses, and Registrations* Applicable Accredited Certifications desired but not required, CQA, CQE, CQM, Clean Room, NC/CAPA, Training.
*Working Conditions* Well- lighted, heated, and air-conditioned indoor office, production, and warehouse area with adequate ventilation.
Job requires lifting to 20 pounds less than 1/3 of the time *Physical Activity Level* Light to medium physical activity performing non-strenuous daily activities of an administrative nature.
Has ability to move and operate freely in office and production areas *Manual Dexterity* Manual dexterity sufficient to work with fingers *Work Schedule/Hours* Scheduled hours are 7:30am to 5:00pm, must be on site.
Infrequent off shift work may be required.
*Vision Requirements* Color vision with the ability to identify and distinguish colors *Travel* Rare to occasional travel to customers, vendors, and educational events *Contacts* Communicates internally with individuals in all departments and externally with vendors and customers *Reports to* QC Manager and dotted line to Compliance Manager.
*https://www.
plastechengineering.
com/about-us* Job Type: Full-time Pay: $80,000.
00 - $100,000.
00 per year Benefits: * 401(k) * 401(k) matching * Dental insurance * Employee assistance program * Flexible spending account * Health insurance * Life insurance * Paid time off * Referral program * Retirement plan * Tuition reimbursement * Vision insurance Experience level: * 5 years Schedule: * Monday to Friday Work setting: * In-person Education: * Bachelor's (Preferred) Experience: * Protocol (IQ/OQ/PQ) execution: 2 years (Preferred) * Validation: 3 years (Preferred) * Med Device or Pharma: 3 years (Preferred) Work Location: In person