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Senior Process Validation Engineer

For Medical or Pharma Industry

Description 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:

Direct validation activities for equipment, systems, and processes utilized in the support of cGMP activities, including developing and executing qualification protocols.
Consult with NPI Program Leads, assess internal and external requirements, and study product/process characteristics to select validation objectives and standards.
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.
Work with cross-functional teams to develop, implement, and maintain User/Functional Requirements and Design Specifications for new equipment and/or automated systems.
Employ risk assessment techniques to drive validation requirements, test plans, and protocol acceptance criteria.
Develop and execute test plans and qualification procedures for equipment, systems, and processes; write and execute required test scripts necessary for verification/validation activities.
Consult with NPI Program Leads and Product Development Engineers and Specialists to develop, implement, and maintain Validation Master Plans (VMP).
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.
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.
Collaborates and coordinates with appropriate departments and staff regarding the scheduling or implementation of validation testing.
Analyze data from validation tests to determine whether equipment, systems, and processes meet required criteria and specifications.
Coordinate and execute performance and functional testing associated with multiple concurrent development and/or infrastructure projects.
Develop, maintain, and/or review validation and compliance documentation including schematics, protocols, reports, and engineering change orders.
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.
Train engineers and other team members to PMI validation procedures and related documents/processes.
Maintain design controls, risk management and project management documentation in accordance with established regulatory requirements and SOPs.
Interacts and collaborates with SMEs to ensure product quality
Execute tasks in compliance with Design Control requirements
Familiarity with the medical device/combination product requirements
Understanding of good engineering practices required to develop and transfer a product
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.
Utilize project planning and monitoring methods to ensure timely completion of tasks.
Proactively communicate issues and forecast potential risks to the Product or Program Lead in a timely manner
Other responsibilities as required.

Education and Experience:

Minimum 3-5 years relevant experience: equipment, system, and/or process validation in pharmaceutical/medical device industry
BS or MS degree in engineering or related technical field

Background Qualifications:

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.
Practical experience with quality risk management and risk-based validation approaches.
Excellent written and verbal communications, including technical writing.
Proficient with Microsoft Office suite
Ability to work well with others, regularly interact with cross-functional teams, and report to program and functional management teams
Self-motivated, able to produce high volume of work with limited supervision.
Organized, able to manage multiple assignments and work effectively under pressure.
Equipment, system, and/or process validation experience in the medical device or pharmaceutical industry.
Thorough understanding of the principles of validation methodologies and testing best practice.
Knowledge of cGMP, GDP, GAMP, 21CFR Part11/210/211/820 and industry best practices.
Ability to understand existing and new business processes and requirements to ensure proper implementation and validation of equipment/systems/processes.
Experience in developing documentation for computer systems (e.g. system validation plans/reports, requirements specifications, risk assessments, traceability matrix, qualification protocols/reports)
Previous experience functioning as project manager for small to moderate-scale projects is preferred

Further Requirements:

Detail- and Quality-oriented mindset
Self-starter; ability to take ownership over processes; Work with limited supervision and take ownership of projects to meet scheduled timeline and technical goals
Remain energized and effective when faced with ambiguity and uncertainty.
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
Maintain frequent interactions with a broad stakeholder network.
Strong understanding for the application of GD&T standards and stack-up tolerance analysis to develop and inspect components and assemblies using product prints.
Capable of making high-quality decisions, even when based on incomplete information or in the face of uncertainty
Highly organized, adept at multi-tasking and work prioritization; thrives in an environment of rapid change.
The ability to use Visio, Excel, Word, Powerpoint and Outlook
Proficient in technical transfers and design control principles for medical devices
Excellent verbal and written communication skills to technically and professionally describe test scenarios, deviations, non-compliances and risks.

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-time

Pay: $70,000.00 - $135,000.00 per year

Benefits: