Technician IV, Project Management

4 weeks ago

Bloomington, United States Disability Solutions Full time

We're hiring a Technician IV, Project Management, to support the project management team in our Bloomington, IN facility.

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. 

The Technician IV, Project Management requires the coordination and writing of cGMP manufacturing batch records or batch summary reports for platform processes. The position responsibilities will include addressing revisions to the documents, supported by subject matter experts. This is a full-time, hourly position and is 100% on-site. The schedule is Monday – Friday 1st shift.

Catalent Biologics in Bloomington, Indiana is a state-of-the-art, GMP manufacturing facility, providing one million sq/ft of 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.   
                                                

The Role

  • Responds to internal comments and works with SMEs to ensure comments are incorporated.

  • Executes procedures of moderate complexity with high quality with a minimum degree of guidance.

  •  Authors non-process batch production records (solution, column, bulk fill) to support cGMP manufacturing with minimal technical understanding.

  • Generates batch production records in accordance with applicable regulator guidance and site SOPs.

  • Authors platform documents from execution batch production records with minimal technical understanding.

  • Copy-edits documents in accordance with applicable regulator guidance and site SOPs.

  • Other duties as assigned.

The Candidate: 

  • Associate’s degree in STEM field required.

  • 8+ years of experience in regulated environment/pharmaceutical industry.

  • GMP experience preferred.

  • Prior experience with scientific or technical writing, highly preferred.

  • Must be able to read and understand English-written job instructions and safety requirements.

Why you should join Catalent

  • Medical, dental, vision, and wellness benefits are effective on the first day of employment.

  • Potential for career growth on an expanding team and organization.

  • 152 hours of paid time off annually plus 8 paid holidays.

  • Community engagement and green initiatives.

  • Engaging D&I Employee Resource Groups.

  • Tuition reimbursement program.

  • Generous 401K match.

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. 

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.

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