We're hiring a Technician II, 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 II, 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
Generates batch production records in accordance with applicable regulatory guidance and site Standard Operating Procedures (SOPs), with minimal technical understanding.
Authors procedures and reports of moderate complexity with high quality and minimum guidance.
Authors SOPs and Work Instructions with minimal technical understanding.
Authors and drive to completion Material Specification Sheets (MSSs) and Change Controls with minimal technical understanding.
Performs SME review of reports for completion and accuracy.
Responds to internal and client feedback; works with SMEs to ensure proper application.
Copy-edits documents in accordance with applicable regulatory guidance and site SOPs.
Supports other activities within the Technical Writing Group as assigned.
Communicates with stakeholders when necessary.
Other duties as assigned.
The Candidate
Associate’s degree required.
Minimum of 2 years of relatable experience.
Prior professional writing experience, highly preferred.
GMP experience, 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.
Engaging Diversity & Inclusion programs including Global Employee Resource Groups.
Community engagement and green initiatives.
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.
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