Company
Humacyte, Inc. is proud to be a vaccinated workplace where all employees are expected to be fully vaccinated against COVID-19. Proof of full vaccination is required before beginning work. Humacyte will provide accommodations as required by law.
Humacyte, Inc. is bringing to market a once in a generation scientific technology platform, bioengineering readily available and universally implantable product opportunities focused on improving lives of patients and transforming the practice of medicine. Located in Durham, NC, the company develops and manufactures acellular tissues for the treatment of diseases and conditions across a wide range of therapeutic areas. The company’s innovative technology supports tissue repair, reconstruction, and replacement while overcoming limitations in existing standards of care. Initially developing a portfolio of human acellular vessels (HAVs), to target multiple vascular markets including trauma, arteriovenous access for hemodialysis, peripheral arterial disease, and coronary artery bypass grafting. Humacyte is focused on the development of future markets such as pediatric heart surgery, delivery of cellular therapies, and multiple other novel cell and tissue systems.
We are looking for additional colleagues to continue to build our expanding team. Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
Position Background:
The Director of Site Engineering is responsible to strategy and execution of Clean Utilities, Metrology & Instrumentation. They are accountable for ensuring equipment and utility reliability through the development and implementation of routine preventative and predictive programs. This position is also responsible for leading the team that provides unplanned troubleshooting support to all pertinent cross-functional areas as it relates to Clean Utilities, Metrology & Instrumentation.
This position reports to the VP of Operations
Remote Work Designation: Non-Remote
Major Accountabilities:
- Responsible for translating departmental goals into strategic and operational tactics for Clean Utilities, Metrology & Instrumentation to support the attainment of financial and strategic goals.
- Develops current and long-range strategies and objectives for Clean Utilities, Metrology & Instrumentation that align with overall company strategy.
- Collaborate cross-functionally to resolve complex and abstract cross-functional issues through expert collaboration, idea generation, influencing and negotiation for optimal overall organizational effectiveness.
- Ensures observance and adherence to all safety precautions and regulations in all areas where duties are performed by team members.
- Perform all aspects of personnel leadership for the assigned teams to include staffing strategy aligned with corporate objectives, recruitment, performance management, professional development and retention of team members.
- Leads team in identifying and resolving calibration, equipment, and clean utilities systems malfunctions in a timely, efficient and cost-effective manner with little to no disruption to facility operation activities.
- Develop staffing strategies for best utilizing team members and prioritizing maintenance team member workload in alignment with overall corporate objectives.
- Generates new ideals to improve efficiency, reduce cost or eliminate waste.
- Develops the strategic plan to provide continuous improvements in Overall Equipment Effectiveness (OEE)
- Directs assigned resources to timely resolve maintenance investigations, deviations, and corrective actions as necessary.
- Reviews and approves SOPs, work instructions, preventative and predictive maintenance programs, calibration assessments, job plans, spare parts lists, risk assessments, and reports.
- Business owners of the site’s Computerized Maintenance Management System (CMMS)
- Ensures processes and resources are allocated to insure spare part availability.
- Collaborates cross functionality to coordinate maintenance events to include resource planning, change overs, preventative maintenance, and project scheduling.
- Other duties, as assigned
Special Competencies:
- Ability to lead, motivate, and recruit a diverse and inclusive team.
- Proven experience in Lean and continuous improvement methodologies.
- Must possess a disciplined approach to schedules, standards, and procedures required to facilitate and implement improvements.
- Customer focused to provide quality service and improve equipment and process reliability have strong analytical and problem-solving skills.
- Ability to seek input and empower others, shares ownership and visibility.
- Expert level skills related to routine preventive maintenance and complex troubleshooting of mechanical production equipment and clean utilities system.
- Expert level skills with pneumatic, mechanical, and electrical instrumentation; as well as manual and computer-based process control loops and systems
- Advanced understanding and application of instrument, equipment, and loop calibrations of various parameters in manufacturing, utilities, and laboratory environments
- Advanced understanding of safety requirements and demonstrated ability to implement safe practices.
- Must be able to work in a team-oriented, fast-paced start-up environment and must be willing to work off-shifts, overtime and weekends as necessary for business need.
General Competencies:
- Able to communicate effectively in English, both verbally and in writing
- Possess a positive roll-up-the-sleeves attitude and optimistic outlook
- Represents the organization in a positive and professional manner
- Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
- Excellent organizational and time management skills with ability to set own priorities in a timely manner
- High degree of flexibility and adaptability
- Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook
- Must be able to work as needed to meet tight deadlines and at peak periods
- Self-motivated and organized critical thinker with solid interpersonal and business communication skills
- Demonstrated ability to work in a cross functional team
- Adheres to company and facility specific policies and procedures, including SOP, training and meeting requirements
- Always observe safety precautions and regulations in all areas where duties are performed
- Responsible for reporting all safety hazards and potential unsafe working conditions
- Reports to work on time and as scheduled
QUALIFICATIONS:
- A four-year degree in Engineering, Life Sciences, other related technical
- Minimum 10 years’ experience in supporting manufacturing equipment and utilities in a cGMP environment.
- Previous experience leading teams with multiple accountabilities.
- Proven experience with cGMP requirements for the lifecycle maintenance of production equipment and the documentation requirements associated with a cGMP environment.
- Knowledge and experience with maintenance of biotech / bioprocessing production procedures, equipment and clean utilities
- Proven ability to project manages cross functional teams.
- Knowledge and understanding of reliability centered maintenance practices and sound engineering practices and principles.
- Subject Matter Expert in metrology and instrumentation maintenance services to assure reliability in manufacturing, utilities, and laboratory environments.
- Advanced understanding of safety requirements and demonstrated ability to implement safe practices while working on electrical, control, and instrumentation panels.
- Experience managing vendors and support personnel
Perks:
- Stock Options
- 401k Plan with 4% Match and no Vesting Schedule
- Medical, Vision and Dental Plans
- Company Paid Long Term/Short Term Disability
- Company Paid Life Insurance
- 23 Days Paid Time Off (PTO)
- 10 Company Designated Holidays + 2 Floating Holidays
- Paid Parental Leave Policies
**Please note, Humacyte does not provide sponsorship at this time.**