Lead Process Engineer in BioPharma

1 week ago

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

Position Overview

DPS Group is seeking a highly skilled Senior Process Project Engineer specializing in the biopharmaceutical sector. This role involves overseeing equipment commissioning, calibration tasks, and maintaining documentation within a GMP (Good Manufacturing Practice) environment. The ideal candidate will possess the technical expertise necessary to support project timelines, documentation, facility management, and vendor coordination, ensuring project integrity 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 technologies.
  • Collaborate with a multidisciplinary team of scientists, automation specialists, facility personnel, and operational experts to swiftly address the evolving needs of GMP manufacturing and laboratory projects for CDMO clients.
  • Participate in new product introduction initiatives, including facility fit assessments, process flow diagram creation, and P&ID development, while assisting the MSAT team in equipment selection and operational planning.
  • Provide expert process and technical input to support facility design and capital project execution.
  • Independently perform tasks that offer technical guidance for the execution of smaller projects, making informed decisions and keeping the Project Leader or Sponsor updated on actions taken.
  • Assemble and lead small project teams focused on capital project planning and execution.
  • Engage with the Facilities team to aid in the identification, development, planning, and execution of expense projects, including the management of facility shutdown activities.
  • Continuously seek and recommend enhancements to site processes and procedures.
  • Qualify vendors, solicit bids, evaluate bid submissions, expedite equipment delivery, communicate equipment issues, and coordinate vendor equipment startup.
  • Develop and maintain project management and quality delivery procedures, adhering to relevant policies for collaboration with design and delivery partners.
  • Stay informed about advancements in cell and gene therapy production processes, equipment, instrumentation, and systems.
  • Understand and optimize end-to-end business processes, ensuring compliance with internal and external regulations, and perform process re-engineering as necessary.
  • Exhibit strong analytical skills to interpret and manipulate data, identifying trends to guide future process improvements in collaboration with key stakeholders.
  • Direct and manage engineering teams on 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, review batch sheets, ensure regulatory compliance, monitor processes, investigate deviations, and formulate 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, along with expedited project delivery methodologies.
  • Ability to merge technical knowledge with project delivery to achieve optimal outcomes while maintaining focus on cost and schedule constraints.
  • Strong organizational, interpersonal, verbal, and written communication skills.
  • Capability to prioritize multiple commitments and solve technical problems effectively.
  • Flexibility to adjust priorities based on departmental or facility needs, while considering various ideas and approaches.
  • Possession of legal US work authorization documents as required.

Additional Information

To excel in this role, candidates must demonstrate the ability to fulfill essential duties satisfactorily. The qualifications 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: Self-assess strengths and weaknesses, pursue training opportunities, seek feedback for performance improvement, and share expertise with others.
  • Culture: Support a culture of excellence, contributing 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, integrating changes smoothly, and setting clear goals and objectives.
  • 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 to enhance productivity.
  • Language Ability: Read and interpret safety rules, operating instructions, and procedure manuals; write routine reports; and communicate effectively with groups.
  • Mathematical Ability: Work with mathematical concepts and apply them to practical situations.
  • Reasoning Ability: Apply common sense to follow instructions and address problems involving multiple variables.

About DPS Group

DPS Group is a global EPCMV firm dedicated to providing comprehensive solutions within the Life Sciences and Advanced Technology sectors. Our commitment to delivering successful projects is underscored by 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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