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Technical Services Specialist
2 weeks ago
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**:
- 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.
**Job Types**: Full-time, Permanent
**Salary**: $50,003.85-$107,159.28 per year
**Benefits**:
- Dental care
- Extended health care
- Life insurance
- Paid time off
- RRSP match
Schedule:
- Monday to Friday
Ability to commute/relocate:
- Arnprior, ON: reliably commute or plan to relocate before starting work (required)
Work Location: In person
