Validation Engineer

2 months ago

Boston, United States DPS Group LLC Full time
Summary

The CQV Engineer will report to the CQV Manager to execute Commissioning, Qualification and Validation activities for a client in the Boston, MA area. The ideal candidate will be responsible for executing CQV activities at the new facility and to collaborate with Global Engineering, Facilities Operations, GIS, QA and PMO throughout the life cycle of the project.

Key Responsibilities
  • Develop and execute Analytical Instrument CQV Test Plan and Protocols.
  • Conduct Analytical Instrumentation Qualifications in accordance with USP and SOPs.
  • Conduct Automation Assessments to ensure compliance with 21 CFR Part 11.
  • Coordinate with vendor personnel to schedule and execute of test plans.
  • Coordinates with the construction team and operations to safely and effectively schedule CQV activities.
  • Effectively works with cross departmental stakeholders, PMO, GIS, EH&S, Global Security, design teams, EHS and QA.
  • Completes assigned training and ensures that they are 100% compliant 100% of the time.
  • Ensure that all CQV activities align with the current SOPs, global standards and cGMP guidelines.
  • Supports right-the-first time culture for all documents distributed across the organization. Ensure the Global Engineering reputation and partnership is flourished with the cross-functional teams.
  • Other duties as assigned
Skills & Qualifications
  • Demonstrated ability to safely execute CQV activities in a dynamic fast paced environment.
  • Experience developing and executing CQV protocols in a GMP Analytical Laboratory.
  • Receptive to change - Adapts (quickly) to changing circumstances
  • B.A, B.S. in Engineering or related discipline with 3-5 years of CQV experience or equivalent professional experience.
  • Understanding and application of technical principles, theories, and concepts in the field, GMP, ISO, GAMP, ANSI.
  • 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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