Technician IV, PM

Company: Disability Solutions
Location: Bloomington
Posted on: October 24, 2024

Job Description:

Technician IV, PMPosition 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 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 Technician II, PM 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. --The Manufacturing Sciences and Technology (MS&T) department's primary function is to serve as an agile technical services team to support process & technology transfer (e.g., mAbs, fusion proteins, mRNA, new modalities, etc.), equipment, consumables, technical writing, and drug substance lifecycle management.--This position is 1st shift Monday-Friday 8AM-5PM. Position is 100% on site at Catalent's Bloomington, Indiana facility.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:------- --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; high school diploma required------- --8+ years of experience in regulated environment/pharmaceutical industry------- --GMP experience preferred; ability to understand and write assigned SOPs and moderately complex batch production records with minimal guidance.------- --Possesses a scientific or writing background, strong organizational skills, and a high attention to detail.------- --Applied knowledge of Word, Excel, PowerPoint, and other and applies technical knowledge to assist and train the site with Microsoft troubleshooting.------- --Has introductory knowledge of the principles, theories, and concepts of a discipline.------- --Requires adaptability, analyzing, assessing, calculating, decision making, dependability, good judgment, reading, memorizing, social skills, speaking, stress control, writing.------- --Executes work plan/schedule developed with input from senior team member; excellent written communications skills with internal customers; ability to address work issues at both an individual level and team level.------- --Ability to communicate effectively and follow/retain detailed written and verbal instruction in an accurate, timely, safe, and professional manner with supervisor, group members, and other departments as necessary, in a professional and accurate manner.------- --Work environment: Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening; occasional stooping, kneeling, crouching, bending, carrying, grasping. Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 50 pounds. --Working in a lab environment will require working with skin irritants, lung irritants, electrical equipment, sharp instruments, toxic materials, and hazardous waste. Safety procedures will be followed to minimize exposure, including clean room gowning.Why you should join Catalent:------- --Defined career path and annual performance review and feedback process--------- --Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives--------- --Dynamic, fast-paced work environment------- --Generous 401K match and Paid Time Off accrual--------- --Medical, dental and vision benefits effective day one of employment--------- --Tuition Reimbursement--------- --Wellhub program to promote overall physical wellness--------- --Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories--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 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, Noblesville , Technician IV, PM, Professions , Bloomington, Indiana