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Process Specialist, Operations

Jubilant HollisterStier JHS

This is a Full-time position in Quebec, QC posted April 21, 2021.

Jubilant HollisterSiter, a subsidiary of Jubilant Pharma Holdings Inc, is currently recruiting for a Process Specialist, Operations position to join our growing team What can we offer?

A culture that values opportunity for professional growth and development, highly competitive base pay, comprehensive medical, dental and disability benefits programs, group retirement savings program, health and wellness programs.

Jubilant HollisterStier is a rapiuly growing company with offices in Kirkland, QC and Spokane, Washington.

Our facilities in North America provide specialized manufacturing for the pharmaceutical and biopharmaceutical industries.

We provide a full-range of support and services to streamline the manufacturing process such as on-site assistance from process qualifications through product release.

Jubilant HollisterStier is a proud member of the Jubilant Pharma family.

For more information, visit

We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions’ through growth, cost effectiveness and wise investment of resources.

If you’re up for a rewarding challenge, we invite you to take the first step and apply today Jubilant Pharma Holdings Inc and all our subsidiaries prouuly embraces diversity in our workforce.

Our goal is to have a workforce as diverse as the patients and clients we serve.

We have an inclusive environment where our employees can thrive and where our differences are welcomed.

By welcoming our differences, we create products that are beneficial for our patients, clients, and overall human health.

Summary The Process Specialist, Operations actively participates and leads the calibration, calibration, knowledge transfer, troubleshooting and project management activities (such as continuous improvement projects, scale-up, site transfer or new product transfers).

The Process Specialist, Operations will identify, assess and improve processes in operations including but not limited to manufacturing and packaging.

This will also include the assessment of NPI’s (New Product Introduction) feasibility related to production processes and actions to ensure the smooth transfer to production lines in terms of production capability and will serve as a backup for the floor supervisors.

Responsabilités Production Operations Identify projects based on data analysis, departments requiring improvements and feedback.

Conduct and mentor projects and improvement teams to carry out the identified projects.

Conduct Kaizen workshops.

Manage and support the introduction of new equipment or new process for respective areas.

Write and update SOPs as required while conducting process improvement projects of for NPI’s (New Product Introduction) or for new equipment introduction.

Write and update MBRs as required while conducting process improvement projects or for NPI’s or defined sector and follow up on necessary corrective measures.

Technical Expertise and Project Management Build and maintain extensive technical knowledge and expertise for some products processes, equipment and so forth.

Provide technical support for commercial products during routine manufacturing.

Provide technical acumen, troubleshooting and problem solving expertise to various departments and project teams.

Review, analyze or collect pertinent product and process data in order to review or improve product and process performance.

Participate or lead various technical, optimization or continuous improvement projects or sub-projects (incl.

scale-up, site transfer, new product transfer).

Support colleagues and teams in various cross-functional projects or due diligence efforts requiring technical skills or validation support.

Support the implementation and extensive use of project management tools and processes, good engineering practices (GEPs), risk assessments (e.g.

FMEA), continuous improvement and lean manufacturing techniques.

Validation and Calibration Develop, maintain and oversee the execution of the preventive maintenance and calibration program for the production, R&D and QC departments.

Evaluate the impact of equipment modification and repairs.

Support the Engineering department for the equipment installation and qualification (e.g.

URS, FAT, SAT, etc.) In a timely manner, create, review and/or approve SOP and DEP as well as create or review validation documentation (protocols/reports…) and ensure that such documentation are in full compliance with Good Manufacturing Practices (GMP) and internal regulations.

Review the validation and maintenance/calibration programs process, SOPs, MBRs, other documents and propose improvements to allow operational efficiency while ensuring completeness, robustness and compliance of these programs.

Performs any other tasks assigned by Management.

Bachelor degree in engineering in science.

Project management certification an asset Minimum 5 years of experience in the pharmaceuticals industries with at least 3 in a similar role.

Good knowledge of GMPs Proficiency in Word and Excel Proficiency in French and English (Written and spoken) Sound technical acumen, problem identification and solving capabilities Good analytical skills and detailed oriented Proactive and result oriented.

Excellent interpersonal skills and team work approach.

Ability to work efficiently in a cross-functional team Good communication skills Autonomous and resourcefulness Ability to meet pre-established deadlines