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Validation Specialist III - 60702 (Añasco)

One Group
Añasco, PR

Quick Apply

Job Details

Full-time | Contract

Qualifications

Laboratory testing protocol documentation
Spanish
Customer communication
Teamwork
Document review (document control)
GAMP
Content creation for technical audiences
Defect resolution root cause analysis
Requirements specification
Requirements design
Automation
Procedural guides
Technical documentation
Bachelor of Science
Engineering
Gap analysis
English
System design for system development
Manufacturing facility experience
Bachelor's degree in engineering
Managing engineering teams
Production validation processes
Bachelor's degree
Quality control documentation
Requirements analysis
Filtration
Compliance documentation
Quality inspection
Pneumatic systems
Biomedical regulatory compliance

Full Job Description

Title: Validation Specialist III - 60702 (Añasco)

Job Type: Professional services contract.

Duration: Depends on project schedule

Where: Añasco, On-Site

Hour Rate: Depends on the expertise. Negotiable

MINIMUM QUALIFICATIONS

Education and/or experience:

BS in Mechanical Engineering, Industrial Engineering, Chemical Engineering or related science.
Experience in the medical device and/or pharmaceutical manufacturing environment; on a Facilities project validation engineer position.
Experience in HIPPA filtration.
Experience in Building Automation Computer System Validation
Protocol generation and execution
Experience in HVAC & Utilities
IQ, OQ and PQ Validation
Protocol generation and execution
Experience in Compressed Air Systems & Utilities

Responsibilities:

Plans, develops, and implements documentation, procedures, and trainings necessary for the engineering team.
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.
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.
Develop statistically based sampling plans for in-process and final testing and inspections, and validations.
Review and approve validations and completion reports for new and existing computer and automation systems.
Troubleshooting computer and automation systems that do not perform as intended during validation runs.
Recommend process/quality improvements as part of validation runs. Work with new and existing manufacturing and laboratory equipment, processes, utilities and facilities with computer or automation systems.
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.
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.
Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
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.
Lead process improvement projects to improve the validation of computerized systems.
Oversee validation contractor resources. 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.
Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
Work on project teams with other internal departments, external vendors, and customers as required. Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions.
Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
Performs other related duties as necessary. Qualifications: 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.
6+ years of experience.
Bachelor's Degree is required.

Qualifications:

Knowledge of FDA, OSHA, and GMP's and ISO requirements.
Must have a thorough understanding of verification and validation processes.
Must have excellent communication skills and a strong track record of working cross-functionally.
Experience with managing documents within electronic PLM system.
Must have demonstrated ability to think strategically.
Must be able to develop technical documentation such as: Change Controls, Validation Plans, Gap Assessments, Validation Protocols (IQ/OQ/PQ), Technical / investigation reports, SOP, and others.
Teamwork oriented and self-starter.

Other Requirements:

Excellent interpersonal and communication skill at all levels.
Fully bilingual (English and Spanish).
Must speak Spanish fluently (native).
Teamwork oriented and self-starter.
Need to have full attention to details.
Skills in working under time pressure.
Availability to work extended hours in a day and weekends if required.
Available to start as soon as possible.
Must live in Puerto Rico. No relocation nor travel expenses available.
Resumes must be in English.
We seek experienced professionals; no training will be given on the position requirements.
Please note: This position does not offer visa sponsorship. Applicants must be fluent in both Spanish and English. Kindly refrain from applying if you do not meet these requirements. No C2C available.
Are you a match? Please apply to Indeed position OR send your updated resume to [email protected] and include the job title in the subject line.

Job Types: Full-time, Contract

Application Question(s):

Do you have an engineering or related science bachelor degree?

Education:

Bachelor's (Required)

Experience:

Project Validation Engineer: 3 years (Required)

Language:

Spanish (Required)
English (Required)

Ability to Commute:

Añasco, PR 00610 (Required)

Work Location: In person

Quick Apply

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