Advanced Process Engineer

2 weeks ago

Rahway, New Jersey, United States DPS Group Global Full time

Position Overview

DPS Group is seeking a highly skilled BioPharma Senior Process Project Engineer to oversee equipment commissioning, calibration activities, and documentation within a GMP framework. The successful candidate will possess the necessary technical expertise to support project timelines, documentation, facilities, and vendor interactions, ensuring project precision and quality from inception to completion.

Key Responsibilities

  • Demonstrate proficiency with critical utilities, tangential flow filtration (TFF), portable reactors made of stainless steel or Hastelloy, chromatography skids, containment systems, high-temperature/high-pressure solvent dispensing, temperature control modules, milling equipment, and single-use systems (mixers, inline dilution).
  • Collaborate with a multidisciplinary team of scientists, automation engineers, facilities personnel, and operations specialists to swiftly address the evolving needs of GMP manufacturing and laboratory utilization for CDMO client projects.
  • Participate in new product introduction initiatives, including facility fit analysis, process flow diagram creation, and P&ID development, while supporting the MSAT team in equipment selection and unit operation planning.
  • Contribute expert process and technical insights to facility design and capital project execution efforts.
  • Provide technical guidance for the execution of smaller projects with minimal supervision, making independent decisions and informing the Project Leader or Sponsor of actions taken.
  • Assemble and lead small project teams for capital project planning and execution.
  • Engage with the Facilities group to assist in identifying, developing, planning, and delivering expense projects, as well as managing facility shutdown activities.
  • Proactively identify and recommend enhancements to site processes and procedures.
  • Qualify vendors, solicit bids, review bid contents, expedite equipment delivery, communicate equipment issues, and coordinate vendor equipment startup.
  • Develop project management and quality delivery procedures while adhering to relevant policies for interaction with project design and delivery partners.
  • Maintain a strong understanding of technological advancements in cell and gene therapy production processes, equipment, instrumentation, and systems.
  • Comprehend end-to-end business processes, ensuring they are optimized, compliant with internal and external regulations, and capable of performing process re-engineering.
  • Exhibit strong reporting skills, with the ability to analyze and manipulate data to identify trends and share process road mapping for future changes with key stakeholders.
  • Direct and manage engineers on new product introductions and/or technical transfers to and from the site, including new technologies.
  • Oversee daily project development plans.
  • Evaluate raw materials, develop process fits, conduct safety and environmental reviews, batch sheet assessments, regulatory compliance checks, process monitoring, cycle-time studies, deviation investigations, and resolution, as well as develop filing strategies.
  • Demonstrate proven experience in process optimization, change management, and business analysis.

Qualifications

  • Bachelor's degree in an Engineering discipline.
  • Familiarity with project identification and development, as well as expedited project delivery methodologies.
  • Ability to integrate technical knowledge with project delivery to achieve optimal project outcomes while maintaining focus on cost and schedule constraints.
  • Strong organizational, interpersonal, verbal, and written communication skills.
  • Ability to prioritize multiple commitments and possess technical problem-solving aptitude.
  • Flexibility to adjust priorities based on departmental or facility needs, while considering various ideas and approaches.
  • Legal authorization to work in the U.S. is required.

Additional Information

To succeed in this role, an individual must effectively perform each essential duty. The requirements listed below represent the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

  • Continuous Learning: Assess personal strengths and weaknesses, pursue training opportunities, seek feedback for performance improvement, and share expertise with others.
  • Culture: Support a culture of excellence and contribute to a collaborative environment that values teamwork, mentorship, and pride in workmanship.
  • Customer Service: Display courtesy and sensitivity, manage challenging customer situations, meet commitments, and respond promptly to customer needs.
  • Planning and Organizing: Prioritize and plan work activities efficiently, set goals and objectives, and work in an organized manner.
  • Teamwork: Balance team and individual responsibilities, contribute to a positive team spirit, and welcome feedback.
  • Use of Technology: Demonstrate required skills, adapt to new technologies, and troubleshoot technological issues.
  • Language Ability: Read and interpret documents, write routine reports, and communicate effectively.
  • Mathematical Ability: Work with mathematical concepts and apply them to practical situations.
  • Reasoning Ability: Apply common sense to carry out instructions and address problems involving concrete variables.

About DPS Group

DPS Group is a global EPCMV firm providing comprehensive solutions within the Life Sciences (pharmaceutical, biotechnology, and medical technology) and Advanced Technology (semiconductor, data center, and solar) sectors. We are committed to delivering successful projects with a client-first mentality and a personal touch across various market sectors, including 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. Employment selection decisions are based on merit, qualifications, and abilities, without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity, disability, veteran status, or any other characteristic protected by law.

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