Catalent Pharma Solutions Senior Director, Engineering in Chelsea, Massachusetts
Title: Senior/Director Engineering
Location: Chelsea, MA
The Senior / Director of Engineering is a key leadership position with responsibility for Process Engineering, Reliability Engineering, Automation Engineering, and Facility Maintenance functions to support of clinical /commercial spray drying, encapsulation and blistering operation s.
This role reports to the GM of Site Operation s and is a member of the Site Leadership Team accountable for department management including performance, talent recruitment, strategic planning, capital programs, and budget.
A high level of initiative, energy, and motivation are key role requirements, as well as excellent leadership, technical understanding and management of complexity and effective collaboration with internal and external stakeholders, including CDMO clients ensuring successful delivery of product.
Essential responsibilities include but are not limited to the following:
Lead a high performing team that maintains and champions a diverse and inclusive workplace.
Support the site’s ability to win new CDMO business with urgent and accurate capital project scope definition and cost estimates to support strategic partnerships with our customer’s proprietary technologies.
Organize, manage, develop and implement project plans, designs, assembly of equipment, processes, and systems to ensure timely project completion, in compliance with regulatory agency requirements, internal company standards and current industry practices.
Recruit top talent with every hiring opportunity and motivate/develop members of the department to be key leaders within the organization. Build and sustain employee engagement by creating a culture of efficient execution and an environment in which individuals and team can excel and continuous ly improve.
Develop and regularly update the strategic capital improvement plan including site master plan & maximize the success rate for production operation s by instituting programs to minimize mechanical failure and enhance equipment and systems performance.
Maintain facilities in an appropriate and compliant manner: Utilities, Maintenance, Security , Automation etc. This includes management of all the space at the facilities and assignment of offices. Developing and maintaining a Validated State for all GMP -relevant equipment and systems.
Drives collaboration with the product development/technical operation s group during equipment selection, process development activities, technology transfer, scale up, PAR studies, and process validation.
Manages the troubleshooting and resolution of technical problems to support the manufac turing schedule.
Ensures robust quality event management system execution, including deviations / investigations are resourced and completed on time, and CAPA are thoughtfully initiated and precisely executed.
Assesses revisions to and conducts gap assessments against manufac turing / production corporate standards; proactively drives actions and projects to close gaps.
Education or Equivalent:
Bachelor’s degree in a scientific or engineering field or related discipline and a minimum of 8+ years of relevant experience required. Master’s degree in a scientific or engineering field or related discipline and 6+ years of relevant experience preferred.
Prior supervisory experience required. Experience working in an FDA regulated operation required.
Understanding/knowledge of particle engineering/spray drying for the oral and inhalation market, including down stream processing operation s
Demonstrated leadership and project management skills
Exceptional communication skills to effectively interact at all levels of the organization including site presentations to both clients and executive management
Demonstrated ability to partner with other functional groups to achieve business objectives required.
Experience successfully leading transformational change
- Must have the ability to lift up to 50 pounds .
Collaborative and inclusive
Professional Office Setting
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
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