Validation Engineer
RCM Technologies
Contract Title: Validation Engineer Compensation: $65/Hr. Location: Southwest of Boston Length of Contract: 12 months Position Description: The purpose of the Validation Engineer (contract position) 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. 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.
Qualifications:
+ Minimum of 7 yrs experience in engineering or equivalent and an engineering bachelor's degree
+ 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.
Education & Certifications:
+ Minimum of 7 yrs experience in engineering or equivalent and an engineering bachelor's degree
Equal Opportunity Statement: RCM is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Pay Transparency: RCM believes in transparency and fairness in compensation. We are committed to providing our employees with competitive salaries that reflect their skills, experience, and contributions to our organization. As part of our commitment to pay transparency, we want to provide you with as much information as possible about our compensation practices. Disclaimer: This job posting is intended to describe the general nature and the level of the work to be performed. It is not intended to include every job duty and responsibility specific to the position. RCM reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. About RCM: RCM is a leading provider of Business, IT, and Engineering Services to over 1,000 clients in the commercial marketplace. RCM partners with clients to define, implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America.
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