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Title

Associate Director, Engineering & Facilities 

Category Facility Management  
Description

Why Join Societal CDMO?  

Mission and Culture:

Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients’ lives through client partnerships. Whether you are working hands-on developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.

We foster a culture that is diverse, inclusive, challenging, and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization and we encourage our employees to continue their personal and professional development in a variety of ways.

Benefits:

We offer a competitive total rewards package that includes health benefits, annual performance bonus, stock options, generous paid time off, holiday shutdowns, parental leave, matching 401k contributions and much more!

Your New Role At Societal:

We are looking for an Associate Director, Facilities & Engineering to join our San Diego site. In this role you will enable operational success of the site, overseeing maintenance and utility operational activities and commissioning of new equipment. You will be responsible for planning and tracking project schedules, budgets and milestones while ensuring facilities and utilities meet regulatory requirements and adhere to Societal’ s Quality Systems.

How You Will Make An Impact:

  • Oversee maintenance and engineering functions at the assigned facility, to include manufacturing equipment, utility operations, and general facility management initiatives.
  • Oversees all compliance related issues including Corrective Action / Preventative Action Plans (CAPAs), Deviations, Periodic Reviews and Change Controls related to facilities and engineering projects.
  • Lead and/or oversee the execution of facilities/engineering investigations of existing site challenges and to identify continuous improvement efforts for site manufacturing, packaging, facilities and utilities systems, and development of proposals to optimize performance.
  • Lead and/or supervise the execution of engineering investigations into site modifications and expansions to meet business opportunities and regulatory requirements.
  • Develop and maintain site facility and engineering procedures and associated documents to ensure effective and compliant execution of work on site. This may also include supervision of technicians verifying and updating documentation.
  • Develop engineering documentation required by manufacturing and packaging operations, facilities, utilities, and/or new projects. This will include development of specifications, test protocols, procedures and the like.
  • Manage project engineering for new site projects. For site-based projects, this may include project and construction management. For large projects [generally those involving a third-party engineering contractor], this may include design guidance, review and approval, and liaison with site functions, as site engineering representative.
  • Assist with development of validation and commissioning protocols.
  • Ensure that site maintenance and engineering activities are performed in a safe manner with compliance to all cGMP requirements.
  • In partnership with EHS professionals across the organization, develop or implement programs that drive site EHS performance along with environmental and energy programs.

 

As a Leader You Will:

  • Plans organizational structure, position content and staffing.
  • Identifies, recruits and retains top-notch talent.
  • Coaches, mentors the team and provides career development/learning opportunities.
  • Sets performance standards and encourages employee engagement through delegation, continuous feedback, goal setting and performance management.
 
Position Requirements

Ideal Candidate Will Bring:

  • B.S degree in Chemical, Electrical, Industrial, Mechanical or Pharmaceutical Engineering, Master’s degree preferred.
  • Generally a minimum 10 years’ experience in pharmaceutical facilities/engineering role within a GLP/GMP environment, minimum 7 years of leadership experience.
  • Project Management experience/certification, Green Belt/Black Belt Certification, and Certified Maintenance and Reliability Professional (CMRP) certification Sound knowledge of engineering aspects of pharmaceutical manufacturing facilities, commissioning and qualification of systems is highly preferred.
  • Working knowledge of aseptic filling, lyophilization, solid oral dose manufacturing, and packaging equipment.
  • Working knowledge of HVAC and utility systems, including building automation / management systems and computerized maintenance management systems.
  • Experience with budgeting for operational expenses and capital projects.
  • Prior experience and knowledge of reliability principles and predictive maintenance tools (including asset life cycle management and condition monitoring) would be an asset.
  • Prior experience with EHS related programs would be an asset.
  • Demonstrated experience participating in site, division, corporate or regulatory audits.
  • Ability to analyze and resolve complex problems in terms of fundamental engineering and / or scientific principles.
  • Ability to apply engineering and / or scientific principles to the development of procedures, specifications and standards for systems and equipment new to the site.
  • Ability to execute, document and present investigations into engineering-related issues.
  • Ability to apply project management principles to new projects and plan, organize and execute such projects.

 

New hires will pass a background check, drug screen, and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.

We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.  If you require an accommodation to complete the application or interview process, please contact careers@societalcdmo.com.

 
About the Organization Societal is a bi-coastal contract development and manufacturing organization (CDMO) with expertise to deliver on our client's needs, regardless of complexity level. These projects span pre-Investigational New Drug (IND) development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms. We provide industry leading support for small molecule therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. We do all of this in our best-in-class facilities in San Diego, California and Gainesville, Georgia.





If you would like to apply for this position, please visit our website at www.societalcdmo.com and click on the "Careers" section.




New hires will pass a background check, drug screen and will be required to show proof of COVID vaccination (subject to limited qualified exemptions) as a condition of employment.
 
EOE Statement We are an equal opportunity employer (EOE) dedicated to a diverse workforce and Drug Free work environment. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other characteristic protected by law.  
EmpID None Specified 

This position is currently accepting applications.

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