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Principal Manufacturing Specialist

Company: Catalent Pharma Solutions, Inc.
Location: Bloomington
Posted on: September 23, 2022

Job Description:

Principal Manufacturing Specialist, Primary, Formulation, Filling, Monday-Friday, 1st Shift

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 hiring a Principal Manufacturing Specialist. A Principal Manufacturing Specialist provides direct technical support to operations area as it relates to documentation, equipment procurement, testing, operational excellence, and training. This role works collaboratively with multiple company functions to ensure production systems operate in a safe, and quality-oriented manner. The Principal Manufacturing Specialist's primary duty is to provide support for all Client and Regulatory Agency Audits and management of process and procedural improvements. The role will be "Process" related and the Specialist will act as the Subject Matter Expert. Responsibilities include: Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP document revision, review and approval, lead and participate in continuous improvement opportunities.

This is a full time position. The hours are Monday-Friday, 1st Shift.

Catalent Pharma Solutions in Bloomington, Indiana is a state of the art, GMP manufacturing facility, providing one million sq/ft of a drug substance manufacturing, drug product manufacturing, and related pharmaceutical services. This award-winning facility helps customers accelerate biologic drug development programs and bring better treatments to help patients 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:

* Has advanced and specialized expertise in an analytical/scientific method or operational process, typically developed through a combination of job-related training and considerable on-the-job experience
* Completes assignments and facilitates the work activities of others; may coordinate work beyond own area
* Proposes improvements to processes and methods
* Direct interaction with Client and Regulatory Auditors
* Lead and guide all tours related to client and regulatory audits
* Proposes improvements to processes and methods
* Direct interaction with Client and Regulatory Auditors
* Acts as a lead, coordinating the work of others
* Works autonomously within established procedures and practices
* Competent at-risk mitigation for function
* Write and revise SOP's, WI's, Batch Records, and Forms
* Support or own work orders, deviations, and audit observations for equipment activities
* Actively participates, suggests solutions to problems, and drives to timelines
* Perform Investigations and Root Cause Analysis in Global Trackwise quality system utilizing technical writing skills
* Ensure documentation is accurate and effectively assessing and mitigating risk associated with manufacturing activities
* Create and assist in implementation of Corrective and Preventative Actions (CAPAs)
* All other duties as assigned

The Candidate:

* High School/GED with 8+ years' pharmaceutical and/or manufacturing experience required OR
* Associate degree with 5+ years' pharmaceutical and/or manufacturing experience required OR
* Bachelor's degree in a manufacturing field of study with 3+ year of pharmaceutical and/or manufacturing experience preferred
* Audit and inspection experience required
* Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

* Defined career path and annual performance review and feedback process
* Diverse, inclusive culture
* 152 hours of PTO + 8 paid holidays
* Dynamic, fast-paced work environment
* Positive working environment focusing on continually improving processes to remain innovative
* Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
* Competitive salary with quarterly bonus potential
* Community engagement and green initiatives
* Generous 401K match and Paid Time Off accrual
* Medical, dental and vision benefits effective day one of employment
* Tuition Reimbursement
* On-site fitness center and wellness programs

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.

Keywords: Catalent Pharma Solutions, Inc., Bloomington , Principal Manufacturing Specialist, Education / Teaching , Bloomington, Indiana

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