Senior Project Engineer for Biopharmaceuticals

2 weeks ago

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

Position Overview

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

Key Responsibilities

  • Demonstrate familiarity 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 equipment (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 client projects.
  • Participate in new product introduction initiatives, including facility fit analysis, process flow diagram and P&ID development, and assist the MSAT team in equipment selection and unit operation planning.
  • Provide expert process and technical input to support facility design and capital project execution.
  • Independently execute small projects, providing technical guidance and making decisions while keeping the Project Leader or Sponsor informed of actions taken.
  • Assemble and lead small project teams focused on capital project planning and execution.
  • Engage with the Facilities group to assist in identifying, developing, planning, and delivering expense projects, including managing facilities 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, adhering to relevant policies for interaction with project design and delivery partners.
  • Maintain a high level of familiarity with technological advancements in cell and gene therapy production processes, equipment, instrumentation, and systems.
  • Understand 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, analyzing and manipulating data to identify trends and share process road mapping for future changes with key stakeholders.
  • Direct and manage engineers during new product introductions and technical transfers, including the integration of new technologies.
  • Oversee daily project development plans.
  • Evaluate raw materials, develop process fits, conduct safety and environmental reviews, batch sheet reviews, ensure regulatory and validation compliance, monitor processes, conduct cycle-time studies, investigate deviations, and develop filing strategies.
  • Demonstrate proven experience in process optimization, improvement, 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 approaches.
  • Ability to integrate technical knowledge with project delivery, achieving optimal project outcomes while focusing on cost and schedule constraints.
  • Strong organizational, interpersonal, verbal, and written communication skills.
  • Ability to prioritize multiple commitments and solve technical problems effectively.
  • Flexibility to adjust priorities based on departmental or facility needs, considering various ideas and approaches.
  • Possess legal US work authorization documents as required.

Additional Information

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

Company Overview

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. DPS is 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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