Technical Services Specialist

2 weeks ago

Strathroy, Canada Catalent Full time

**Technical Services Specialist**

Strathroy, Ontario is 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.

**Position Summary**

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 or 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.

**The Role**
- In collaboration with R & D, QA and Operations, plan, coordinate, and drive assigned projects by workings with staff and Project Management. within the Catalent Project Management framework, to ensure timelines are met, roadblocks are identified early, and resources are coordinated.
- With R & D. QA and Operations, participate in the evaluation and risk assessment of project/program data in order 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.
- 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.
- Prepare and execute process validation protocols, process validation reports, study protocols and reports as appropriate.
- Operate under and maintain GMP/GLP conditions.
- Must be able to work extended hours. weekends as needed, especially when problems occur or when deadlines must be met
- Perform other duties as required
- Bachelor's Degree in Pharmacy, Science, Engineering (Chem., Indus., Mech., Elec.) or related field.
- 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

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

**Why you should join Catalent**:

- Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance).
- Group Retirement Savings -Registered Pension Plan (RPP) with employer contributions.
- Paid Time Off Programs incl. vacation, banked time & personal time.
- Employee Reward & Recognition programs.
- Opportunities for professional and personal development & growth incl. 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 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 and does not discriminate based on any characteristic protected by local law.

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