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Manufacturing Calibrations Specialist I
Position Summary
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.
Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
Reporting to the Metrology Manager, the Manufacturing Calibrations Specialist I performs calibrations on site pharmaceutical manufacturing equipment used to manufacture oral solid dosage products.
Hours: 8:00 am – 5 pm; Monday – Friday with a 30-minute unpaid lunch.
The Role
• Perform equipment preventive maintenance and calibration procedures.
• Compile and maintain all information and documentation relevant to all work in accordance with FDA guidelines.
• Work with manufacturing operators to schedule calibrations.
• Coordinate repairs/installations with facilities staff, contractors and users to minimize interruptions.
• Partner with manufacturing staff, users and vendors to continuously improve operations.
• Work from standard operating procedures.
• Enter and track calibrations in Base Maintenance Repair and Alterations Module database.
• Other duties as assigned.
The Candidate
• High school diploma required, Associate degree in technical or life sciences discipline preferred.
• 2+ years of pharmaceutical experience is required.
• 3+ years of manufacturing calibration experience preferred.
• Blue Mountain Regulatory Asset Manager experience preferred.
• Good understanding of cGMPs, industry and regulatory standards and guidelines.
• Good understanding of federal and local regulations regarding health and safety within manufacturing and packaging environments.
• Requires the use of hands for simple grasping and fine manipulations.
• Requires bending, squatting, reaching, pushing, climbing.
• Requires the ability to stand for extended periods of time.
• Some exposure to hazardous chemical and other active chemical ingredients.
• This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
Why You Should Join Catalent
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan with company match.
• Fast-paced, dynamic environment.
• 152 hours of PTO + 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 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:
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 HERE.
