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Poly-Med, Inc.

For Medical or Pharma IndustryDescription for New Product Development Validation Engineer:The NPI Product Development Validation Lead Engineer directs initiatives to plan, qualify, and implement new equipment, systems, and/or processes in accordance with Poly-Med Quality procedures and regulatory standards. This role will report to the NPI Product Development Program Lead and will lead validation activities within project teams. The NPI Validation Lead will work closely with cross-functional project teams and stakeholders with the objective of validating and implementing developmental equipment, systems, and processes, in accordance with the PMI Quality System, regulatory requirements, and industry best practices.Scope:This is a full-time, on-site position. This role is an Independent Contributor role. There is the potential for direct reports for this position.Responsibilities:<ul><li>Direct validation activities for equipment, systems, and processes utilized in the support of cGMP activities, including developing and executing qualification protocols.</li><li>Consult with NPI Program Leads, assess internal and external requirements, and study product/process characteristics to select validation objectives and standards.</li><li>Support validation activities including requirements gathering, validation planning, authoring validation lifecycle documentation including run plans, test plans and test scripts, execution of test scripts, and discrepancy management.</li><li>Work with cross-functional teams to develop, implement, and maintain User/Functional Requirements and Design Specifications for new equipment and/or automated systems.</li><li>Employ risk assessment techniques to drive validation requirements, test plans, and protocol acceptance criteria.</li><li>Develop and execute test plans and qualification procedures for equipment, systems, and processes; write and execute required test scripts necessary for verification/validation activities.</li><li>Consult with NPI Program Leads and Product Development Engineers and Specialists to develop, implement, and maintain Validation Master Plans (VMP).</li><li>Lead development and execution of Installation Qualification, Operation Qualification, and Performance Qualification (IQ/OQ/PQ) protocols per PMI QMS procedures; write and implement summary reports for each qualification protocol.</li><li>Lead the design, development, implementation, and execution of validation test scripts/test plans to identify potential equipment, system, and/or process issues; perform root cause analysis and document action plan.</li><li>Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.</li><li>Analyze data from validation tests to determine whether equipment, systems, and processes meet required criteria and specifications.</li><li>Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.</li><li>Develop, maintain, and/or review validation and compliance documentation including schematics, protocols, reports, and engineering change orders.</li><li>Ensure that verification and validation testing is sufficient to meet regulatory requirements (21 CFR Part 11, 21 CFR Part 820, ISO 13485, ISO 14971, etc.) and PMI standard procedures.</li><li>Train engineers and other team members to PMI validation procedures and related documents/processes.</li><li>Maintain design controls, risk management and project management documentation in accordance with established regulatory requirements and SOPs.</li><li>Interacts and collaborates with SMEs to ensure product quality</li><li>Execute tasks in compliance with Design Control requirements</li><li>Familiarity with the medical device/combination product requirements</li><li>Understanding of good engineering practices required to develop and transfer a product</li><li>This role requires execution of engineering and project management capabilities for one or more sub-projects under the direction of a Product or Program Lead. A moderate knowledge of project management and knowledge of the product process flow is required.</li><li>Utilize project planning and monitoring methods to ensure timely completion of tasks.</li><li>Proactively communicate issues and forecast potential risks to the Product or Program Lead in a timely manner</li><li>Other responsibilities as required.</li></ul>Education and Experience:<ul><li>Minimum 3-5 years relevant experience: equipment, system, and/or process validation in pharmaceutical/medical device industry</li><li>BS or MS degree in engineering or related technical field</li></ul>Background Qualifications:<ul><li>Understanding of industry standards and best practices for validation and knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11, Part 210/211, and Part 820.</li><li>Practical experience with quality risk management and risk-based validation approaches.</li><li>Excellent written and verbal communications, including technical writing.</li><li>Proficient with Microsoft Office suite</li><li>Ability to work well with others, regularly interact with cross-functional teams, and report to program and functional management teams</li><li>Self-motivated, able to produce high volume of work with limited supervision.</li><li>Organized, able to manage multiple assignments and work effectively under pressure.</li><li>Equipment, system, and/or process validation experience in the medical device or pharmaceutical industry.</li><li>Thorough understanding of the principles of validation methodologies and testing best practice.</li><li>Knowledge of cGMP, GDP, GAMP, 21CFR Part11/210/211/820 and industry best practices.</li><li>Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of equipment/systems/processes.</li><li>Experience in developing documentation for computer systems (e.g. system validation plans/reports, requirements specifications, risk assessments, traceability matrix, qualification protocols/reports)</li><li>Previous experience functioning as project manager for small to moderate-scale projects is preferred</li></ul>Further Requirements:<ul><li>Detail- and Quality-oriented mindset</li><li>Self-starter; ability to take ownership over processes; Work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals</li><li>Remain energized and effective when faced with ambiguity and uncertainty.</li><li>Models collaboration across the organization. Embrace and foster values of Integrity, Positivity, Healthy Conflict Resolution, Excellence, Courageous Leadership and Servant-Leadership. Displays courtesy, tact and respect when dealing with others. Solid relationship building and management skills; professional demeanor and proactive follow-through with a collaborative approach</li><li>Maintain frequent interactions with a broad stakeholder network.</li><li>Strong understanding for the application of GD&amp;T standards and stack-up tolerance analysis to develop and inspect components and assemblies using product prints.</li><li>Capable of making high-quality decisions, even when based on incomplete information or in the face of uncertainty</li><li>Highly organized, adept at multi-tasking and work prioritization; thrives in an environment of rapid change.</li><li>The ability to use Visio, Excel, Word, Powerpoint and Outlook</li><li>Proficient in technical transfers and design control principles for medical devices</li><li>Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.</li></ul>Working Conditions at Poly-Med, Inc.This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.Job Type: Full-timePay: $70,000.00 - $135,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Parental leave</li><li>Professional development assistance</li><li>Referral program</li><li>Relocation assistance</li><li>Retirement plan</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul>Schedule:<ul><li>8 hour shift</li><li>Day shift</li><li>Monday to Friday</li><li>No nights</li><li>No weekends</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>medical device: 5 years (Required)</li><li>FDA regulations: 5 years (Required)</li><li>IQ OQ PQ: 4 years (Required)</li><li>Process Validation: 4 years (Required)</li><li>Validation Master Plans: 5 years (Required)</li><li>21 CFR Part 11 and 4: 4 years (Required)</li></ul>Work Location: In person

Senior Process Validation Engineer

Description for Quality Engineer II:This position is self-directed and is responsible for performing Quality Engineering tasks and activities with limited guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within quality assurance field. Relies on personal experience and judgment to perform primary job responsibilities. This role is primarily an Independent Contributor with no direct reports. Interaction is potentially with all levels of the organization.Responsibilities for Quality Engineer II:<ul><li>Responsible for document review, approval and storage related to assigned projects, such as batch cards, MIs, DHR, DMR, DMF, CAPA, ECO, Validations, IP/PS, customer complaints, FMEA, Customer Proposals, Drawings, Design Control, SDS&rsquo;, Calibrations, PM, NCR, Product Shipping, and Label Control.</li><li>Participate in customer and regulatory audits as well as internal audits. When trained may be lead internal or external auditor.</li><li>Responsible for the 21 CFR 820, ISO 13485, and cGMP compliance of the assigned PMI programs.</li><li>Participate in project meetings (product design or internal improvements) as Quality representative supporting compliance and PMI Quality position.</li><li>Recommend and implement effective Quality process improvements.</li><li>Participate in validation teams or work on equipment, process, computer systems and automation validations, as requested.</li><li>Support compliance to Good Documentation Practices in document review and approval.</li><li>Multitask, prioritize, and meet deadlines in timely manner without excessive follow-up.</li><li>Exhibit strong organizational and verbal/written communication skills at multiple levels in the organization.</li><li>Demonstrate leadership skills and communication proficiency to mentor peers in Quality areas, including data analysis, sampling rationale, document reviews, risk-based decision making, and conflict resolution for Quality-related issues.</li></ul>Required Knowledge, Skills and Abilities for Quality Engineer:<ul><li>5+ years hands on experience in a quality role in a regulated industry such as medical device or pharmaceutical</li><li>Skilled with Microsoft Office Software (Microsoft Word, Excel, et. al.)</li><li>Good knowledge of statistics and Mini-tab software</li><li>Good work organizational skills</li><li>Ability to manage time and prioritize</li><li>Excellent communication and interpersonal skills</li><li>Ability to collaboratively interact with people at all levels of the organization</li><li>Good technical writing skills, grammar</li><li>Ability to handle highly confidential business information</li><li>Strong attention to detail</li><li>Ability to think proactively, troubleshoot, investigate and improve systems</li><li>Highly responsible for actions of self and possibly others on the team</li></ul>Education/Experience Requirements<ul><li>Required- Bachelor&rsquo;s Degree (preferably in Engineering discipline) and 5+ years of Medical Device or Pharmaceutical quality experience</li></ul>Preferred Qualifications<ul><li>Experience with equipment, process, software, or automation validation and statistical analysis, generating sample plans, scaling up processes, process mapping</li></ul>Working Conditions at Poly-Med, Inc.At Poly-Med, Inc., the safety and health of every employee are of the utmost importance. The use of personal protective equipment such as safety glasses, hearing protection devices (ear plugs or earmuffs), and gloves may be required in various working areas.Physical Requirements:Employees are regularly required to talk and hear and are frequently required to sit and/or stand for extended periods of time. Employees are frequently required to walk with occasional requirements to climb stairs; use of hands for gross manipulation, reach with hands and arms; and stoop, kneel, and/or crouch. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required by this job include close vision and ability to adjust focus.Poly-Med, Inc. offers a great selection of benefits including vacation time. Poly-Med, Inc. employees are paid once a month.Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.Job Type: Full-timePay: $75,000.00 - $95,000.00 per yearBenefits:<ul><li>401(k)</li><li>401(k) matching</li><li>Dental insurance</li><li>Employee assistance program</li><li>Employee discount</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Professional development assistance</li><li>Referral program</li><li>Retirement plan</li><li>Tuition reimbursement</li><li>Vision insurance</li></ul>Education:<ul><li>Bachelor's (Required)</li></ul>Experience:<ul><li>ISO 13485: 3 years (Required)</li><li>validation: 3 years (Required)</li><li>CAPA: 3 years (Required)</li><li>FDA regulations: 3 years (Required)</li></ul>Work Location: In person

Quality Engineer - II

Join Poly-Med, Inc. and explore 2   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Poly-Med, Inc.

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Senior Process Validation Engineer

Quality Engineer - II