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, 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 AND REQUIREMENTS:

• Degree in Microbiology, Chemistry, Engineering, or a related Science.
• 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.

Job Types: Full-time, Permanent

Salary: $50,003.85-$107,159.28 per year

Schedule:

• Monday to Friday

Work Location: In person