Validation/CQV Engineer

IntePros

Norwood (MA)

On-site

USD 125,000 - 146,000

Full time

14 days+

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Benefits offered by this job

Medical insurance

Vision insurance

401(k)

Job summary

IntePros is seeking a CQV Engineer to support quality and engineering in equipment qualification and process validation. The ideal candidate will have a background in medical devices and substantial experience in drafting qualification protocols and statistical analysis. This role involves collaboration with various teams to ensure compliance and quality in manufacturing processes.

Qualifications

Minimum of 7 years experience in engineering or equivalent.
Medical device experience is a must.
Strong computer skills required.

Responsibilities

Collaborate with Engineering and Quality on equipment/process changes.
Prepare and review validation protocols and reports.
Perform data analysis using statistics.

Skills

Communication

Problem Solving

Critical Thinking

Education

Bachelor's Degree in Engineering

Job description

This range is provided by IntePros. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$60.00/hr - $70.00/hr

Direct message the job poster from IntePros

Senior Recruiter Specializing in Life Sciences and Engineering

The purpose of the CQV Engineer is to complete assignments in support of Quality and Engineering for equipment qualification, new product development, process validation and test method validation. The successful candidate will assume responsibility for drafting qualification protocols, qualification reports and engineering study reports, along with data analysis and an intermediate level of experience in the use of statistics. This position will also support other projected related tasks such as developing strategies and protocols for performance testing, time study and value stream mapping, and development of equipment functional and user requirements.

DUTIES AND RESPONSIBILITIES

Collaborate with Engineering and Quality on equipment / process changes, additions and installs for how to qualify equipment, processes and newly developed coatings
Preparing and reviewing validation protocols, engineering study reports, results from trials and test work, parameter development and operational qualifications, including challenge tests to establish and demonstrate stable processes and capability. Collaborate with document control to approve and release into QMS.
Perform basic to intermediate statistics for the analysis of data
Update, where necessary, the Validation Master Plan with outcomes of executed qualifications / validations
Lead and support process time studies, value stream and process mapping, and capacity analysis
Support development of user, functional, and equipment requirement for new and existing equipment
Work within the established company-wide quality documentation system and QMS, including key aspects such as executing and supporting test methods per procedure, collecting and documenting test results, writing test data reports and procedures
Follow Quality Management System requirements in an ISO 13485 / GMP manufacturing environment
Performs other related duties as assigned by management

QUALIFICATIONS

Minimum of 7yrs experience in engineering or equivalent and an engineering bachelor’s degree
Medical device and/or medical component experience is a must
Can interpret schematics, engineering drawings, written and verbal instructions
Understands the operation and functionality of process equipment; conducts tests and reports data in prescribed format
Experience in planning, preparing and executing validations protocols and reports, writing and implementing procedures, development of processing parameters, executing and documenting trials, IQ/OQ/PQ, navigating quality management systems
Strong computer and communication skills. Fluent in English, both written and spoken
Self-motivated. Able to work effectively both within a team and independently
Proven experience supporting complex problem solving using systematic and critical thinking skills

Seniority level