MedChem Engineering Services LLC is a recruiting and staffing company dedicated to helps companies recruit and manage contingent workers by providing the best talent in the industry for every client needs. MedChem operates in Puerto Rico. For more information, please visit our website: www.medchemengineeringservices.com
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.
Education and/or experience:
- BS in Engineering, preferably Computer, Mechanical, Industrial, Electrical, Chemical, or Biomedical.
- Master Degree is a plus.
- PE License strongly desired.
- Lean/Six Sigma Green or Black Belt Certification is a plus.
- Experience in validations such as: manufacturing equipment, laboratory equipment, cleaning, test method, computer systems, packaging, shipping, shelf life (aging), sterilization, facilities, clean rooms, and utilities (HVAC, Compressed Air, Water Systems) required.
- Minimum of four (4) years of experience in the medical device and/or pharmaceutical manufacturing environment; with at least three (3) years in a validation engineering position.
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:
Ability to Relocate:
- Añasco, PR 00610: Relocate before starting work (Preferred)
Work Location: In person
