DPS Engineering Devens , MA 01434
Posted 3 weeks ago
Summary
DPS Group is seeking a CSV (MES) Engineer to support a client in Devens, MA. The candidate must have MES 3.0 and experience in a pharma/biotech GMP Environment.
Responsibilities
Provide technical support for ensuring that current versions of the Computer System are qualified through verification and maintained in a qualified state
Accurately record data and performing statistical analysis where applicable during execution
Adhere to company procedures and government regulations such as Good Documentation Practices (GDP), GAMP and 21 CFR part 11 when executing protocols
Document deviations and non-conformances that occur as a result of the qualification
Collaborate with Management, Developers, Implementation, business development and client representatives to meet deliverable(s)
Route, Approve, Develop and Revise Requirement Specifications, Test Scripts, Validation Master Plans, supporting documentation for validation, admin manuals and software documentation where applicable
Coordinate with reviewers and approve to finalize documentation
Perform a review of quality systems and manufacturing data, summarize and draw conclusions to be included in individual product assessments
Execute Qualification Protocols
Track and communicate progress of deliverable(s)
Communicate complications or issues in the validation process
Other duties as assigned
Skills and Qualifications
Bachelor's Degree in engineering or related field
Minimum 5 year of validation related experience
Knowledge of writing and reviewing validation documentation
Good understanding of IQ, OQ, PQ, RTM, Test Scripts, Summary Reports, etc
Strong Attention to Detail
Self-motivated and reliable
Knowledge of PC computer operating systems and the Microsoft Office suite
Strong written and oral communication skills
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The Company
DPS Group is a global EPCMV firm offering full-service solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) industries. DPS is dedicated to delivering successful projects with a 'client-first' mentality and personal touch across a range of market sectors: Project and Program Management, Procurement, Design, Construction Management, Health and Safety Management, Commissioning, Qualification, and Start-up.
DPS Engineering Inc. is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. DPS does not discriminate in employment opportunities or practices on the basis of: race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status or any other characteristic protected by country, regional or local law.
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DPS Engineering