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Project Validation Specialist III

Summary Description:
Support European Union Medical Device Regulation (EU MDR) and Design History File (DHF) improvement program Client's site at Añasco, PR for the Tissue Technologies (TT) Product Families. The incumbent will be supporting the following activities to ensure conformance with EU MDR for technical filing of TT products manufactured at Client's site, included in the EU MDR program:

Data Gathering – Participate in the discovery and compilation of required documentation to be evaluated.
Gap Assessments – Support assessment of all manufacturing documentation such as product device master record (drawings, specifications, bill of materials, production router/instructions, procedures, labeling), process flow charts, incoming inspections, in-process inspections, final inspections, validation plans and process validations, among others.
Remediation Plan – Perform tasks identified as part of the remediation plan including, but not limited to: validation documentation generation and execution (change control, validation plans, validation protocols, validation closure reports, technical reports / memos) and manufacturing documentation update through site change orders system.

The incumbent will be working with cross functional areas on activities described above. Responsible for the delivery of tasks to ensure conformance to the project plan schedule.

Perform assessments and review of all manufacturing and validation documentation associated to product families established by EU MDR program. Provide data to support the gap assessments reports and identify remedial action items based on the outcome of gap assessments. Complete assigned remediation activities to ensure that manufacturing processes and operations are in compliance with requirements of EU MDR. Generate and execute validation protocols, including the coordination of all activities required for protocol completion. Interact and coordinate activities with other departments, external vendors, and customers, as required. Update documentation associated with manufacturing processes which can include drawings, specifications, bill of materials, production router/instructions, procedures, labeling, and process flow charts, among others. Provide training in the updated manufacturing documentation as applicable. Analyze manufacturing process information / data, develop, where necessary, technical justification, rationale and/or other information as required by the company to mitigate risk to acceptable level with adequate documentation. Report project status and progress periodically to site management. Perform other related duties, as required.

Work on official documentation to address technical issues on equipment/processes. Perform Remediation activities as deemed required.

MINIMUM QUALIFICATIONS:

Must have knowledge of European Union Medical Device Regulation (EU MDR 2017/745), European Union Medical Device Directive 2007/47/EC and ISO13485:2016 Medical Devices – Quality Management Systems
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Must have excellent communication skills and a strong track record of working cross-functionally.
Ability to assess technical issues and develop solutions utilizing an analytical approach to problem solving.
Teamwork oriented and self-starter.
Fully bilingual (English and Spanish).

Education and/or experience:

BS in Science or Engineering, preferably Mechanical, Industrial, Electrical, Chemical, or Biomedical.
Hands-on experience with EU MDR or MDD remediation projects, compliance projects and process validation required.
Experience with managing documents within electronic PLM system.
Experience with working with cross functional team.
Minimum of 7 years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least seven (7) years in manufacturing process, quality or validation engineering position and preferably with exposure to Packaging Validations, Design Control and Product/Process Transfer.

Other Requirements:

**CANDIDATE MUST LIVE IN PUERTO RICO**
No relocation nor travel expenses.

Job Types: Full-time, Contract

Pay: $33.00 - $36.00 per hour

Education:

Bachelor's (Required)

Ability to Relocate:

Añasco, PR 00610: Relocate before starting work (Preferred)

Work Location: In person

Validation Analyst III

Summary Description:
This position is responsible for the qualification and validation of computer and automation systems. Plans, coordinates, and participates in a compliant validation process for computer and/or automation systems which require formal validation documentation under appropriate regulatory requirements and company standard procedures.

Responsibilities include development of Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, validation protocols (IQ/OQ/PQ) and procedures for new and existing computers systems, as well as directly executing validations, evaluation of quality issues and/or deviations reported during validation protocol execution. Develops, coordinates, and implements validation procedures and practices to produce high quality products within company goals and budget. Coordinates plant activities related to Validation Engineering, assuring that these are carried out timely, efficiently and in compliance with plant procedures and regulatory agencies.

SUPERVISION RECEIVED

This position receives direct supervision from the IT Manager.

SUPERVISION EXERCISED

Individual Contributor. No formal direct reports.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

1. Plans, develops, and implements documentation, procedures, and training necessary for the engineering team.

2. Actively participate in the Validation Life Cycle of regulated projects by reviewing validation documentation, participating in application requirements definition, risk assessments, traceability matrix, validation protocol development, validation testing and deviation management.

3. Generation of validation plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix, as well as development and execution of validation protocols (FAT/SAT/IQ/OQ/PQ), and completion reports. Provide statistical analysis of the date to support the reports.

4. Develop statistically based sampling plans for in-process and final testing and inspections, and validations.

5. Review and approve validations and completion reports for new and existing computer and automation systems.

6. Troubleshooting computer and automation systems that do not perform as intended during validation runs.

7. Recommend process/quality improvements as part of validation runs.

8. Work with new and existing manufacturing and laboratory equipment, processes, utilities and facilities with computer or automation systems.

9. Identifies current and anticipated requirements for compliant computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation necessary to ensure compliance within the operation.

10. Analyzes the results of testing and determines the acceptability of results against predetermined criteria. Evaluate, investigate and document non-conformances incidents and/or protocol deviations.

11. Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.

12. Manages and supervises the installation of equipment and controls/software modifications for automated equipment. Assists with vendor selection, budgeting, procurement of equipment or services, scheduling, vendor coordination, set-up, training, start-up, and troubleshooting.

13. Lead process improvement projects to improve the validation of computerized systems.

14. Oversee validation contractor resources.

15. Generate and report metrics to monitor the performance of Validation System. Prepare information for Quality Management Reviews and Operational Reviews such as: trending charts, Pareto analysis, etc.

16. Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.

17. Work on project teams with other internal departments, external vendors, and customers as required.

18. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.

19. Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.

20. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.

21. Performs other related duties, as necessary.

DESIRED MINIMUM QUALIFICATIONS

Knowledge, skills, and abilities:

Knowledge in Collagen and Silicone technologies and materials as well as lyophilization and dispersion preparation is highly desirable.
Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
Knowledge in Organizational Excellence and Lean/Six Sigma.
Strong Project Management skills.
Knowledge of cost control, and development of guidelines, trainings, and maintenance programs.
Ability to lead teams through complex projects and provide departmental technical leadership.
Must have a thorough understanding of verification and validation processes, including early software or computer systems defect detection and removal, inspection, and testing methods (e.g., types, levels, strategies, tools and documentation). Must be able to analyze test strategies, develop test plans and execution documents, and review customer deliverables.
Must have a strong knowledge and understanding of Computer Systems Validation Life Cycle and regulatory requirements (GAMP 5 and FDA guidelines, among others).
Must be able to generate Validation Plans, User Requirement Specifications (URS), Functional Requirement Specifications (FRS), System Design Specifications (SDS), traceability matrix and validation protocols (IQ/OQ/PQ).
Must understand systems architecture and be able to implement computer systems development and maintenance processes, quantify the fundamental problems and risks associated with various development methodologies, and assess, support, and implement process and technology changes.
Must have excellent communication skills and a strong track record of working cross-functionally.
Must have demonstrated ability to think strategically.
Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
Teamwork oriented and self-starter
Fully bilingual.