Sr. Manager, Facilities
The Sr. Manager, Facilities will support the manufacturing and process development organizations by developing and implementing maintenance and engineering best practices resulting in robust, sustainable, integrated manufacturing processes at BWI location. These are expected to drive improvements in Quality, Reliability, Process Capability, Cost, and Environmental Health and Safety.
The Sr. Manager, Facilities will interact with cross-functional teams to lead the implementation of site changes and facilitate the day-to-day activities supporting manufacturing and site expansion in pharmaceutical manufacturing environments. Key elements of this role include managing the execution of maintenance and metrology activities, assist with the implementation of site capital projects and ensure team compliance for all cGMP requirements. The role will also support oversight of day-to-day business activities in absence of Director of Facilities & Engineering
_Catalent Gene Therapy hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. _
The Role
Provide leadership for site FM strategy for facilities processes. Direct internal and external teams to execute activities supporting facility per cGMP requirements. Assemble the appropriate set of multidisciplinary professionals which integrates support of people, process and technology to ensure the safe, secure and sustainable functionality of the built environment.
Formulate operational procedures and organization to build a team that contributes to the success at the BWI site and corporation. This includes assessing, repairing and upgrading facilities, systems and utilities to ensure the facility and services fully support the occupants and functions housed within them. Identify and evaluate solutions to support change to create a robust/reliable environment. Develop, programs to improve efficiency, heighten performance and ensure the facility meets OSHA health and safety requirements.
Plan and direct activities with overall responsibility for meeting business objectives. Lead in identifying risk, developing strategies, best practices, alternative solutions, resolving issues, etc. in collaboration with cross functional teams. Ensure the use of design for manufacturing, mistake proofing, and quality controls to minimize patient and regulatory compliance risks.
Anticipate financial needs, quantify budget to support planning, and manage budget per plan and schedules.
Establish a collaborative and transparent environment to ensure cross functional support by FM for all site/corporate teams. Application of current Good Manufacturing, Engineering, and Maintenance Practices (cGxPs)
Knowledge of biopharmaceutical equipment, construction, operation, qualification, and maintenance, for example bioreactors, controlled temperature units, utility systems (AWFI, HVAC, Clean Compressed Air, Process Gases), and certain laboratory equipment.
Work to targets and deadlines (planning, organizational and prioritization skills).
The Candidate
Bachelor’s degree in Engineering is preferred; (Engineering, Engineering Management, or Engineering Technology). But additional experience can be accepted in lieu of degree
Minimum of 5 years of experience implementing engineering best practices, as well as experience in managing technical engineering functions. Experience in hands on implementation and support of utility/manufacturing systems within a highly regulated cleanroom manufacturing environment is required.
Experience in compliance Regulations that apply to Quality, Regulatory Compliance (21 CFR Part 11), Environmental Health and Safety, as well as have knowledge of standards related to maintenance processes, construction, equipment design and implementation into global medical device manufacturing facilities.
5+ years of related work experience, prefer in GMP/Bio-Pharma maintenance/engineering environments.
This position requires a professional who will be expected to perform tasks autonomously at times; minimum supervision required on day-to-day activities and accomplished tasks.
Will be required at times to lead projects from start to finish including documentation, scheduling, guiding maintenance mechanics and/or contractors.
Position Benefits
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross-functional exposure to other areas within the organization
Medical, Dental, Vision, and 401K are all offered from day one of employment
Employee Stock Purchase Plan
19 days PTO and 8 paid holidays
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 [email protected] . 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:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.
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