Organogenesis is seeking a highly strategic and detailed-oriented person to join our team as the Director of Capital Projects. In this position, the Director of Capital Projects will be overseeing the comprehensive lifecycle of all construction initiatives. This position manages the strategic planning, design, engineering, and construction of critical capital projects that directly support the organization's manufacturing and logistics objectives. Projects include new manufacturing and office buildings, and logistical/warehousing buildings as well as major upgrades to existing clean rooms, shipping areas, offices, and laboratories to meet the company and customer needs. In this position, the Director of Capital Projects will implement commissioning and startup activities and maintain facilities-related Quality System Regulation (QSR) documentation. This position is responsible for keeping projects on track to established project timelines, reporting on project progress and setting metrics for critical deadlines.

How You Will Achieve It:

• Manage project lifecycles effectively, utilizing robust cost controls and efficient resource allocation strategies to meet critical deadlines and budget requirements
• Responsible for reporting project progress and outcomes to stakeholders.
• Develop and manage Facilities capital budget for Organogenesis.
• Develop necessary processes and SOP’s to support large scale capital projects.
• Develop procedures and systems to ensure projects meet governmental regulations and QSR requirements.
• Ensure projects meet GMP documentation needs.  These documents include URS, FRS as well as submittals to support commissioning and validation processes.
• Ensure PCO and ECR processes are followed to make approved Facility modifications as needed to support manufacturing operations. This will include the commissioning phase as well as supporting validation activities.
• Ensure new projects meet expected corporate growth goals.
• Manage the contracts and construction plans for all new facilities.
• Responsible for managing project construction personnel, project engineers and contractors. 
• Additional related duties as assigned.

Requirements

What You Need to Achieve It

• BS in an engineering discipline such as mechanical, chemical, industrial technology or equivalent required.
• MS in relevant field preferred.
• 12 years of experience managing Capital Projects in the Biotechnology, Medical Device or Pharmaceutical space.
• Experience managing full project lifecycle required.
• Deep understanding of mechanical utility systems including HVAC, steam, high purity systems, compressed air, vacuum, etc. required.
• Knowledge and understanding of automated monitoring and control systems required.
• Experience managing significant financial resources and developing budgets required.
• Position works heavily within the QSR environment and thus must have a high standard of commitment to customers and the quality of work. 
• Must possess the ability to handle many projects and priorities at the same time and keep track of important GMP documentation.
• Strong understanding of local, state, and federal code and permitting requirements.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals required. 
• Excellent leadership, communication (both written and verbal), problem-solving, and decision-making skills.
• Proven analytical skills with the ability to define problems, collect data, establish facts, and draw valid conclusions, along with the aptitude to interpret a wide variety of technical instructions in mathematical or diagram form and manage multiple abstract and concrete variables.

Physical Demands

• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• Some physical exertion is required (climbing stairs/ladders or working in confined spaces).
• Entry into the clean rooms requires various levels of gowning.
• High noise levels in and utility rooms may be encountered.
• Work on construction sites will require good balance and footing.
• Minor handling/exposure to hazardous chemicals can be expected.
• Working alone during non-regular business hours (weekends & weeknights) is frequent.

What can we offer you?

• 401k -- generous employer match with immediate vesting and financial planning resources
• Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
• Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
• Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
• Paid maternity leave and parental leave for all new parents
• Adoption benefits
• Education Assistance Policy – up to $5,000 per year for all employees
• Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
• Employee Assistance Program
• Generous paid time off including vacation, floating holidays, sick days, and company holidays
• Free parking including an electric charging station (Canton and La Jolla)
• Discounts at BJs Wholesale, Dell, Sullivan Tire, and Sprint

The anticipated annualized base salary for this role is $185,000 - $230,000 and reflects current market data for similarly-sized life science companies and internal equity.  Organogenesis is a multi-state employer, and this salary range may not reflect positions that work in other states. Base salary is part of our total rewards package which also includes the opportunity for merit-based increases, eligibility for our 401(k) plan with competitive company match, medical, dental, vision, education assistance, life and disability insurances and leaves provided in line with your work state and federal law.  This position is also eligible to participate in the company’s annual management bonus plan. Our time-off policy includes paid vacation days, paid company holidays, and paid sick time.  Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education, and other factors permitted by law.

We are an equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to age, sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, genetic information or any other characteristic protected by law.

We do not accept unsolicited agency resumes and we are not responsible for any fees related to unsolicited resumes.