DPS Engineering Alachua , FL 32615
Posted 1 week ago
Summary
A 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.
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