-
CSV Engineer I
2 weeks ago
Uniqure NV Oklahoma City, United StatesuniQure is dedicated to bringing therapies for unmet medical needs to patients. Each position at uniQure is directly or indirectly responsible to improving the lives of patients. This responsibility is part of our day-to-day working life by living up to high quality standards and ...
-
IT Business Analyst/ Application Engineer
1 week ago
uniQure Oklahoma City, United StatesLocation: Lexington, 113 Hartwell Ave Education level: Bachelor / Graduate · Job category: Information Technology corporate Target start date: 1/22/2024 · Work Location: On-Site Shift: 1st · uniQure is dedicated to bring innovative therapies or unmet medical needs to patients. ...
-
Sr. R&D Engineer
5 days ago
Hired by Matrix Oklahoma City, United States1 month ago · Be among the first 25 applicants · Do you want more than just another job? Are you ready to team up with an organization that values your contributions? Then Hired by Matrix is for you · Working with some of the US' premier companies, we excel at connecting candid ...
-
Automation Engineer
1 week ago
Sirius Technical Services, Inc. Oklahoma City, United StatesReady to dive into the dynamic world of Information Technology? Explore our job opportunities in IT and unlock endless possibilities for growth and innovation. From shaping the future with cutting-edge technologies to making a meaningful impact on society, the IT industry offers ...
-
Senior Data Engineer
21 hours ago
FullStory Oklahoma City, United StatesThis role can be performed remotely anywhere within the United States. · Help unlock the secrets hidden in the vast trove of data at Fullstory. We're looking for an experienced Data Engineer to go spelunking through numerous systems and bring order to a chaotic world. Work with a ...
-
Lead, Complaints
6 days ago
J&J Family of Companies Oklahoma City, United States Paid WorkLead, Complaints / Adverse Events W · Description · Johnson & Johnson is recruiting for a Lead, Complaints / Adverse Events in Raritan, NJ or near a Johnson & Johnson office in India, Switzerland, Belgium, or the United States. This position will require up to 20% travel. · Per o ...
CSV Engineer - Oklahoma City, United States - DPS Group Global
Description
SummaryDPS 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.
Continuous Learning
–Assesses own strengths and weaknesses. Pursues training and development opportunities. Seeks feedback to improve performance. Shares expertise with others. Strives to continuously build knowledge and skills.
Culture
– Supports a culture of excellence. Contributes to a collaborative environment that rewards teamwork, mentorship, best-in-practice development, and pride in workmanship.
Customer Services
– Displays courtesy and sensitivity. Manages difficult or emotional customer situations. Meets commitments. Responds promptly to customer needs. Solicits customer feedback to improve service.
Planning and Organizing
– Prioritizes and Plans work activities. Uses time efficiently. Plans for additional resources. Integrates changes smoothly, Sets goals and objectives. Works in an organized manner.
Teamwork
– Balances team and individual responsibilities. Contributes to building a positive team spirit. Exhibits objectivity and openness to others' views. Gives and welcomes feedback. Puts success of team above own interests.
Use of Technology
– Demonstrates required skills. Adapts to new technologies. Keeps technical skills up to date. Troubleshoots technological problems. Uses technology to increase productivity.
Language Ability
– Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Write routine reports and correspondence. Speak effectively before groups of customers or employees.
Mathematical Ability
– Work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Reasoning Ability
– Apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Deal with problems involving several concrete variables in standardized situations.
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.
#J-18808-Ljbffr