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Technical Services Specialist

2 weeks ago

Strathroy, Canada Catalent Full time

**Technical Services Specialist**

**Position Summary**:
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This position is located in Strathroy, Ontario, one of two sites located in Canada offering softgel development and manufacturing capabilities for the Pharmaceutical and Consumer Health industries. We have a broad range of integrated formulation, manufacturing, analytical and packaging services to offer full-service turnkey solutions.

Reporting to the Technical Services Manager, the Technical Services Specialist will lead projects in order to commercialize new products and technologies and to optimize commercial manufacturing processes. This will include activities such as process scale-up (pertaining to both products and technologies), technical transfers, commercialization, and ongoing product/process stewardship. This will be accomplished by focusing on product/process robustness, quality, customer service and cost performance. The Technical Services Specialist will have an introductory knowledge of various aspects of implementing the drug development process in a regulated environment, including topics such as Quality by Design (QbD), Design of Experiment (DOE) and compliance with regulatory guidelines.

Regular working hours: Monday - Friday, 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch

**The Role**:

- With Research & Development, Quality Assurance and Operations, participate in the evaluation and risk assessment of project/program data to implement products and technologies into commercial production; establish process improvement based on trend analysis and study data; investigate issues and customer complaints and determine corrective actions; and ensure commercial product manufacturing processes are robust.
- Prepare and execute process validation protocols, process validation reports, study protocols and reports as appropriate.
- Represent department on a technical basis for assigned projects at local meetings.
- Effectively communicate in a timely manner with management and other departments within Catalent to ensure clear understanding and acknowledgement of project status, risks, actions, and outcomes.
- Provide direction and communication to operational staff in study execution which includes collection of data as well as proper documentation.
- Participate in risk assessments to develop approaches to technical transfer for products and technologies.
- Operate under and maintain Good Manufacturing Procedures/ Good Laboratory Practice conditions.
- Other duties as assigned.
- Bachelor’s degree in pharmacy, Science, Engineering (Chem., Indus., Mech., Elec.) or related field is required.
- Experience in study design, execution, and reporting an asset.
- Experience working in a manufacturing, pharmaceutical and/or GMP facility an asset.
- Demonstrated ability to work independently. tic initiative and complete assigned projects independently.
- Good writing skills.
- The employee is often required to sit and use their hands and fingers, to handle or feel and to manipulate keys on a keyboard.
- Use of manual dexterity is required.
- The employee is occasionally required to stand, walk, reach with arms and hands, bend, or twist, and to stoop, kneel, crouch or crawl.
- Vision abilities required by this job include close vision.

**Why You Should Join Catalent**:

- Comprehensive Benefit Package. (Health, Dental, Vision, & Life Insurance)
- Group Retirement Savings -Registered Pension Plan (RPP) with employer contributions.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development & growth including tuition reimbursement.

**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 someon