Role details

Director Engineering

Chicago   •   USD150,000 - USD180,000   •  Permanent

Bullet points

  • Come work at a fast growing Start-Up with strong financial backing
  • Seeking a Sr. Director to set the technical agenda

About Our Client

My client is an innovative, biosimilar company focused on developing recombinant proteins and antibody products for major regulated markets and strategic markets globally. Their vision is to make biosimilar medications affordable.

Job Description

  • Plan, manage, organize, and harmonize engineering activities and capital investments in line with Company standards for recombinant manufacturing and sterile product filling.
  • Plan and coordinate appropriately site investment on construction projects for buildings, equipment, and processes in line with cGMP, FDA, and local regulatory expectations.
  • Responsible for leading the maintenance support team's efforts on preventive and facility maintenance ensuring proper application of procedures for procurement of spare parts and creation of SOPs for all new equipment installations for a smooth transition through validation into operation.
  • Oversee plant environmental health and safety programs to meet compliance to all regulatory groups, agencies and ensure a safe and productive environment.
  • Support as a member of the site leadership team all plant engineering activities and site improvement initiatives and results. Ensure objectives are aligned with site goals and objectives
  • Oversee plant-wide qualification, validation and calibration plan utilizing state of the art record keeping following cGMP compliance.
  • Oversee design and construction of innovative devices including bioreactors, other upstream and downstream devices, qualification and implementation of new technology.
  • Manage all capital projects, process improvement projects and infrastructure upgrade projects.
  • Direct and manage site engineering department to clearly define project objectives, map out construction and procurement strategies, identify resources necessary for project completion and develop costs and schedules to ensure flawless execution of project requirements and goals.
  • Supervise plant-wide validation and calibration program.
  • Establish and ensure appropriate application of technical standards and guidelines to achieve project plans and goals.
  • Preparation of investment, engineering and restructuring projects in collaboration with external contractors.
  • Ensures adequate reviews architectural, structural, mechanical, electrical, HVAC and equipment drawings for conformance to design specifications where necessary for facilities engineering efforts.
  • Participate in energy conservation initiative through engineering surveys, design specifications and project execution.
  • Direct and manage personnel activities such as training, performance management, hiring and evaluations, discipline and identification of development opportunities.

The Successful Applicant

Education:

  • Minimum a bachelor's degree from a four-year university/college in Mechanical, Chemical or related Engineering field.
  • Post-graduate business or project management qualification preferred.
  • Six Sigma Black Belt or Process Improvement qualification preferred.
  • PE Certification preferred.



Experience:

  • 3-5 years in pharmaceutical manufacturing
  • 7-10 years pharmaceutical and/or pharmaceutical/consumer healthcare industry experience including implementing, optimizing preventative maintenance programs
  • Sterile experience with Fill & Finish lines and equipment's and facility side
  • Experience with vendor negotiations on price and schedule, and competitive bid practices
  • 5-10 years of previous management and leadership experience in the engineering manufacturing environment.
  • Prior experience in design regulations for pharmaceutical manufacturing validation to meet FDA requirements.
  • Background and knowledge on managing capital projects, meeting deadlines and budgets.
  • Knowledgeable in cGMP compliance, EHS standards, and engineering guidelines/standards.
  • Demonstrated successes in meeting project timelines and budgets.
  • Demonstrated technical understanding of the pharmaceutical industry and of engineering practices.
  • Experience handling patent related activities (Preferred)
  • Demonstrated ability to generate opinions to resolve problems, prioritize solutions, determine appropriate courses of action, gain consensus on recommendations, and implement decisions.
  • Ability to champion change and innovation, drive execution and results, motivate others, and foster collaboration at all levels of the organization.
  • Ability to delegate, train and evaluate, coach, and manage the discipline of others.
  • Sufficient technical experience required to maintain leadership over external contractors.
  • Ability to drive site objections and results, work in a fluid environment, drive culture, and lead area initiatives.
  • Demonstrated organizational skills and attention to detail, ability to function in an atmosphere of constant change with detailed accuracy.
  • Demonstrated interpersonal and leadership skills; ability to function within a team-based organization.
  • Sense of urgency, flexibility, and accountability.
  • Stays current on developments in the engineering field.
  • Experience with BLA and FDA inspections.

What's on Offer

Client is offering Director Engineering position at a Start-up that is changing the Biosimilar space forever. Come join a firm that is seeking moon-shot thinkers!



Offering competitive base + relocation package if necessary

Apply for this job

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