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Associate Director of Manufacturing Process & Facilities Engineering

  • Brooklyn, NY
  • Direct Hire
  • Job ID: SC66-2691712

$160000 to $180000 Per Year

Associate Director of Manufacturing Process & Facilities Engineering

Brooklyn, NY

A medical device company based out of Brooklyn, NY that focuses on bringing new technologies to the animal and human health industries that aim to solve problems associated with wound healing is currently seeking an Associate Director of Manufacturing Process & Facilities Engineering.

A strong candidate will bring
  • Chemical process development & optimization is a (must have)
  • Aseptic experience
  • cGMP experience
  • Clean space experience
  • Alternative technical recommendations
  • Operates with a questioning mindset, bringing problems along with multiple solutions to the table
  • Great attitude and work ethic is key


Job Responsibilities

  • Oversee all process engineering activities including process improvements, process scale-ups, process technology transfers and process validations.
  • Oversee all facilities engineering, including maintenance and repair of all aseptic manufacturing facility infrastructure, HVAC/major mechanical equipment, electrical, plumbing, roofing, utilities, and other infrastructure systems.
  • Act as a technical thought leader in process engineering, facilities engineering and equipment reliability, including providing technical expertise and scientific leadership in troubleshooting, root cause analysis and data trending toward continued manufacturing process and facility improvements.
  • Lead the expansion of manufacturing locations, including site selection, securing bids, managing contracts, oversight of all execution activities.
  • Play a lead role in technology transfer, scale-up and process characterization & validation.
  • Manage projects and schedule and lead execution of regular facility shutdowns
  • Ensure all engineering projects, initiatives, and processes are in conformance with the organization's established policies and objectives as well as in adherence to OSHA, NFPA and other applicable safety codes.
  • Contributes to strategic planning by evaluating and projecting future process and facility needs and proposing options to achieve them.
  • Direct, schedule, and oversee external contractors and facility partners (general contractors, architects, HVAC & chiller technicians, electricians, plumbers, roofers, painters, carpenters, pest and termite control, irrigation, landscapers, etc.)
  • Analyze facility needs, plan and budget for expenditures in collaboration with senior management. Manage the approved capital and facilities related expense budget to ensure that all budgets and schedules are met.
  • Implement maintenance strategies to maintain buildings, mechanical equipment, and other utilities.
  • Ensure compliance with all applicable specifications, standard operating procedures (SOPs), and FDA regulations.
  • Ensure that all budgets, schedules, and performance requirements are met.
  • Improve product quality and cost through interaction with both internal personnel and external suppliers.
  • Apply LEAN and Six Sigma principles to manufacturing operations, with an emphasis on a culture of continuous improvement.
  • Document all cGMP activities in accordance with company policies, procedures, and applicable regulatory standards.
  • Ensure effective selection, training, development, and performance management of the manufacturing team to meet business needs.
  • Other duties may be assigned as deemed necessary by management.

Requirements

  • Bachelor’s degree in engineering or equivalent technical field required.
  • MS degree in Engineering or closely related technical field or MBA preferred
  • 10 years of aseptic manufacturing experience is required.
  • A minimum of 5+ years of direct management experience required, with the ability to manage engineers, scientists and technicians and influence, motivate and drive technical rigor.
  • Hands-on, roll-up-your-sleeves approach with high sense of urgency and drive for results
  • Expertise in technical / process design, development, and process / technology transfer with a thorough understanding of regulatory requirements.
  • Experience with semisolid aseptic formulation and syringe filling lines is strongly preferred.
  • Demonstrated experience managing third-party vendors and service providers.
  • Strong knowledge of medical device regulations (e.g., 21 CFR Part 820), cGMP, and related standards (e.g., ISO 13485) is required.
  • Demonstrated experience managing a biotech facility, including a combination of manufacturing, research, and office space. Experience scaling operations and building new space is preferred.
  • Strong project management and organizational skills, including attention to detail and multi-tasking skills.
  • Demonstrated ability to execute priorities in a fast-paced environment, working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
  • Requires strong leadership and organizational skills including attention to detail and multi-tasking skills.
  • Knowledge of RABS/isolator systems preferred
  • Working knowledge of industry-standard schematic capture and mechanical design CAD tools preferred
  • Ability to identify and analyze complex technical problems and implement innovative solutions is required.
  • Ability to extract key facts from complex information and present concise summaries to management.
  • Knowledge of Lean Manufacturing principles required. Six Sigma Black Belt certification strongly preferred.
  • Demonstrated ability to lead and inspire teams and develop and mentor individuals and allocate resource strategically and according to the portfolio priorities.
  • Excellent written and verbal communication skills, good interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators) are required.
  • Experience working under pressure with tight timelines with the ability to maintain a sense of priorities focus and urgency.
  • Extensive experience with using project management and/or collaboration tools (e.g., Microsoft Project) required. Strong working knowledge of Microsoft Office is required.
  • Legal authorization to work in the United States and not require future sponsorship for employment visa status (e.g. H1-B status) now or in the future is required.

Benefits

  • Medical, Dental, and Vision Insurance-Day-1
  • Paid vacations & holidays
  • Firm Paid Life and Short-Term Disability Coverage
  • 401(k) Retirement Savings Plan-5%

Seniority Level

Mid-Senior level

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