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Technical Services Specialist – Aseptic Products
Pillar5 Pharma Inc., an industry leading Canadian CDMO specializing in off-the-shelf sterile pharmaceuticals for the North American market, is searching for an Technical Services Specialist – Aseptic Products, in Arnprior, ON. Reporting to the Technical Services Manager, the Specialist’s role is to provide technical support to Aseptic Manufacturing Operations and support the Sr Aseptic Technical Specialist as required.
Responsibilities
- Provide technical support to Aseptic Manufacturing Operations in problem solving and evaluating new processes, equipment and systems.
- Assist or lead the execution of validation/qualification activities (equipment/process) associated with aseptic manufacturing – this includes Engineering changes that are identified as top priorities
- Assist the Sr Aseptic Technical Specialist with ongoing compliance activities such as autoclave validation, gamma irradiation qualification, filter validation and other activities to support all ophthalmic filling operations
- Lead or co-lead Media Fill Performance Qualifications, and any associated investigations and CAPAs
- Manage cross-functional projects, of various types (product changes, continuous improvement initiatives, raw material changes etc.)
Qualifications
- B.Sc. in Microbiology or a similar scientific discipline
- Minimum of 2 – 5 years experience in a pharmaceutical manufacturing environment
- Experience with Aseptic product transfers and Aseptic manufacturing is highly desirable
- Proven project coordination track record. PMP designation is considered an asset
- Excellent organizational, interpersonal and communication skills
- Proven ability to work with and lead cross-functional project teams
- Experience in technical writing, continuous improvement, statistical analysis, root cause analysis and problem solving techniques
- Understanding of Six Sigma/LEAN methodologies
- Knowledge of the Canadian and US GMP regulatory environment
- Knowledge of quality systems such as SOPs, change control, validation, and batch record requirements
Why us?
- We are a proud Canadian company in a small town, and we care about our shared environment.
- We provide a safe and clean work environment.
- We offer flexible work policies and encourage strong work-life balance.
- We encourage and drive personal and professional development within our organization.
- We have expanded our operations with a new facility, providing the opportunity for growth and new challenges.
Application Process
Please send your resume using the form below.