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Process Validation Engineer
DPS Group Global Alachua, FL
$86k-99k (estimate)
Full Time 1 Day Ago
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DPS Group Global is Hiring a Process Validation Engineer Near Alachua, FL

SummaryA Process Engineer is responsible for ensuring operability and reliability of GMP manufacturing process equipment located at manufacturing facilities. This Candidate provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual will also work closely with Equipment SMEs, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment.
Responsibilities
  • The individual will be responsible for development of the validation plan and any requisite risk assessments to support the process validation of the AAV & HSV drug substance manufacturing processes (two separate, but generally related processes).
  • Ideal candidate will have experience with Process Validation as well as solid understanding of gene therapy manufacturing processes (single-use product contact items, mostly closed system process, basic cell expansion, bioreactor operations, simple small scale TFF & Chromatography clarification processes).
  • Comprehensive understanding of how the process equipment contributed to manufacture.
  • This person will need to help with the definition of CPPs, build out a comprehensive process map, organize the risk assessments to evaluate the failure modes of the various MFG steps, and that will transition into the development of the validation plan.
  • Will ultimately provide oversight of the PV execution
  • Provides process engineering service support and coordinate various engineering activities with outside groups (e.g., Manufacturing, Facilities, Validation, Quality). This individual will also work closely with Equipment SMEs, MS&T and equipment End Users to investigate and troubleshoot issues related to process equipment.
  • Other duties as assigned
Skills And Qualifications
  • 4-6 Years experience in a GMP manufacturing / engineering environment and a B.E. / B.S. degree in Chemical Engineering or related
  • Must have experience in installing and executing new equipment.
  • Must have previous Biotech or Biopharmaceutical industry experience working in a process engineering role
  • Must have strong knowledge and experience supporting single?use systems.
  • Good report and technical writing skills with the ability to drive changes in a cross functional team environment
  • Experience with all aspects of biotech and pharmaceutical industries.
  • Demonstrates good interpersonal skills, is attentive and approachable.
  • Maintains a professional and productive relationship with area management and co-workers.
  • Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation.
AdditionalTo 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 CompanyDPS 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.

Job Summary

JOB TYPE

Full Time

SALARY

$86k-99k (estimate)

POST DATE

06/29/2024

EXPIRATION DATE

07/25/2024

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The following is the career advancement route for Process Validation Engineer positions, which can be used as a reference in future career path planning. As a Process Validation Engineer, it can be promoted into senior positions as a Validation Engineer III that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Process Validation Engineer. You can explore the career advancement for a Process Validation Engineer below and select your interested title to get hiring information.