Validation Scientist and Quality Specialist

ECHO ConsultingGroup; Caguas (PR); On-site; USD 60,000 - 80,000; Full time

Benefits offered by this job

Professional development

Training

Competitive compensation

Job summary

ECHO ConsultingGroup is looking for a Validation Scientist and Quality Specialist in Caguas, Puerto Rico. This role involves regulatory compliance, quality assurance, and collaborative teamwork in the healthcare sector.

The ideal candidate will have a Bachelor's degree in a related science and experience in a FDA regulated environment. Responsibilities include developing protocols, analyzing data, and preparing technical reports. ECHO offers a dynamic and supportive work environment with opportunities for professional growth.

Qualifications

• Experience in a FDA Regulated environment.
• Thorough knowledge of Good Documentation Practices (cGDP).
• Experience in writing technical documents including validation documents.
• Excellent interpersonal skills and attention to detail.

Responsibilities

• Develop and execute protocols and prepare final reports.
• Analyze data and present conclusions to clients.
• Organize, schedule and track projects to meet client requirements.

Skills

Cleaning

Equipment Qualification

Process Understanding

Sterilization Knowledge

Quality Assurance

Education

Bachelor's degree in a related science

Job description

Validation Scientist and Quality Specialist

ECHO Consulting Group is a highly successful and growing consulting company for the Healthcare industry for the last 13 years. ECHO offers professional development, training, competitive compensation, plus a stimulating and collaborative work environment. We are committed in providing exciting career opportunities in a work environment that values trust, respect, teamwork, creative talent, enthusiasm and diligence.

We are currently looking to identify outstanding and qualified resources with experience in any of the following areas to join our team.

• CLEANING (Calculate contact surface area, establish acceptance limits and sampling plan, development of reports and master plans)
• EQUIPMENT (Understand concept of Design Qualification, experience in FAT, IQ, OQ, PQ for Lab, manufacturing & packaging equipment)
• PROCESS (Understand the relationship between process parameters, quality attributes, acceptance criteria and the lifecycle approach)
• STERILIZATION (Prepare and calibrate TC’s, autoclaves, SIP’s, P & ID’s, knowledge in using Kaye Validator)
• QUALITY (Strong experience in Investigations and CAPA (using Trackwise or SAP), generation and administration of Change Controls. Strong knowledge and experience in Regulatory area)

• Able to integrate into a dynamic cross-functional team responsible for supporting/implementing activities.
• Develop and execute protocols and prepare final reports following plant procedures and regulatory requirements.
• Analyze data, and present conclusions and recommendations to clients.
• Organize, schedule and track projects in order to meet client requirements within agreed time lines.

• A minimum Bachelor's degree in a related science (Engineering, Chemistry, Biotechnology or Life Science)
• Experience working in a FDA Regulated environment.
• A thorough knowledge of Good Documentation Practices (cGDP), excellent verbal and written communication skills.
• Experience in writing technical documents, including validation documents (protocols and reports), assessments and investigations.
• Excellent interpersonal skills, coupled with a superb attention to detail, excellent review and analytical skills.
• Must have strong ability to organize and manage multiple tasks in a fast-paced environment. The ability to work effectively with team members and work under minimal supervision.
• Filed experience in validation equipments.