Senior Facilities Mechanic

Company: Disability Solutions
Location: Severn
Posted on: September 2, 2024

Job Description:

The Sr. Facilities Mechanic will provide engineering support of critical utilities used in GMP manufacturing. This individual will work with the Facilities and Engineering teams, as well as Manufacturing to design and scale-out manufacturing capability and support manufacturing operations, as well as improve existing manufacturing operations and facilities.Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.The role:

• Lead the design, implementation, and commissioning for new utility equipment and modifications to existing utility equipment and facilities within GMP Manufacturing while maintaining company quality and safety standards.
• Author and review protocols, standard operating procedures, and provide technical assessment and approval for engineering and process changes as well as documentation pertaining to qualification, and validation to meet regulatory requirements with respect to facility and utility systems.
• Work with industry /consultants to create design specifications, P&ID drawings, GA drawings, User Requirements, Functional Specifications and automation control strategies. Drive standardization within the department and within the company.
• Write and review technical documentation such as protocols and reports for FATs, SATs, and IQ/OQ/PQ testing.
• Provide technical solutions to facility and utility equipment problems, develop reports that evaluate multiple solutions, share findings with appropriate personnel and make recommendations for problem resolution.
• Perform investigations of manufacturing deviations and anomalies related to failure of facility systems.
• Perform utility monitoring, utility capability, statistical analysis and quality engineering activities.
• Provide Facilities with technical support fort audits and inspections.The candidate:
  • Bachelor's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Five (5) years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
  • Associate's degree in Chemical, Biochemical or Mechanical Engineering, Biotechnology or equivalent and Seven (7) years of related experience supporting manufacturing, preferably in the biotech or pharmaceutical industry
  • Working knowledge of cGMP manufacturing and regulatory requirements for biologics and pharmaceuticals
  • Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
  • In-depth understanding and knowledge of Clean Utility Systems including; WFI generation and distribution, purified water generation and distribution, clean steam generation and distribution, HVAC for clean rooms, clean gas generation and distributionCatalent 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 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 . 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice .

Keywords: Disability Solutions, Severn , Senior Facilities Mechanic, Engineering , Severn, Maryland