Validation Engineer

1 month ago

Durham, United States DPS Group Global Full time
Summary
ADPS is looking for a Validation Engineer in Durham, NC. The client site is implementing an electronic logbook (eLogbook) software, and it will require validation work for the new software for creation and testing of logbooks for each functional area.
As a part of the onboarding of this new eLogbook software, work will be required to meet site Validation requirements.
Responsibilities
  • Provide support for Commissioning and Qualification activities for the required system
  • Author and execute Commissioning and Qualification documents, including, but not limited to:
  • URS
  • Qualification Plans
  • Development Protocols
  • Risk Assessments
  • Qualification Protocol(s) including deviation support during physical execution
  • Qualification Reports
  • Collaborate and work directly with team members to complete project deliverables. Ensure to stay informed on general project information including but not limited to decisions, changes, plans of work, due dates, and issues.
  • Attend project meetings related to implementation, document reviews, and schedule reviews
  • Track deliverables and milestones and escalate delays to Validation Management
  • Escalate project or technical changes, issues, risks, and outstanding decisions to Validation Management
  • Other duties as assigned
Skills And Qualifications
  • BS (MS preferred), in Engineering
  • Experience preforming and executing CQV activities
  • Experience working in a multi-disciplinary design office or equivalent client team
  • Demonstrated CQV experience in design consultancy and/or client-site environments
  • Knowledge of typical biotech/pharmaceutical manufacturing systems and equipment
  • Excellent communication skills, both written and verbal
  • Excellent teamwork and interpersonal skills
  • Excellent analytic, problem-solving and decision-making skills
  • Advanced time management and organizational skills
  • Leadership skills, with a view to managing people
  • Results and customer-oriented, strong communication skills
  • Demonstrated ability to learn and quickly apply new concepts and technical information
  • Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
Additional Skills Required:
In order to perform a client assignment for DPS successfully, an individual must be able to perform each essential duty to high technical standard. 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.

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