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Senior Aseptic Filling Project Engineer

Pillar5 Pharma Inc. -
Arnprior, ON

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Détails du poste

Permanent | Temps plein
De 110 000 $ à 145 000 $ par an

Profil recherché

Actions correctives en contrôle de la qualité
AutoCAD
Expérience en gestion de projets ou programmes techniques
Analyse des causes fondamentales des défauts
Gestion des fournisseurs
Mise en service de systèmes
Ingénierie
Ingénierie mécanique
Investigation des déviations en contrôle de la qualité
Actions correctives et préventives (CAPA)
Bonnes pratiques de fabrication (BPF)
Soutien technique
Microsoft Office
Diplôme d'études secondaires
Gestion du changement
Contrôleur logique programmable
Amélioration continue
Emballage
Surveillance environnementale
Gestion de budget
Production
Implication dans la phase de mise en service
Analyse des causes profondes
Technique aseptique
Génie manufacturier
Microsoft Project
Collaboration interfonctionnelle
Leadership
Expérience en gestion de projet
Communication interfonctionnelle

Description complète du poste

Pillar5 Pharma is seeking an experienced Senior Project Engineer / Senior Aseptic Filling Engineer to lead the implementation of new aseptic manufacturing and packaging capabilities within our growing sterile ophthalmic manufacturing operations. This role is responsible for managing complex capital projects from concept through commercial production, ensuring new equipment, systems, and processes are successfully designed, installed, commissioned, validated, and transitioned into operation. Working closely with Quality, Validation, Manufacturing, Maintenance, and Operations, the successful candidate will support the expansion of Pillar5's aseptic manufacturing capabilities while driving improvements in capacity, reliability, compliance, and operational performance.

RESPONSIBILITIES: 

Lead engineering projects related to aseptic filling, packaging, sterilization systems, equipment upgrades, and facility expansion initiatives.
Manage all phases of project execution including scope development, budgeting, scheduling, procurement, installation, commissioning, validation, startup, and handover to Operations.
Develop and maintain project plans, ensuring alignment with operational, quality, validation, regulatory, and business requirements.
Prepare and manage engineering documentation including URS, FDS, SOPs, work instructions, change controls, engineering assessments, and technical procedures.
Coordinate equipment design reviews and manage relationships with vendors, contractors, suppliers, and system integrators.
Support and oversee FAT, SAT, DQ, IQ, OQ, commissioning, and validation activities for new and modified equipment.
Provide technical leadership and troubleshooting support for aseptic filling, packaging, sterilization, and related manufacturing systems.
Support the implementation, operation, and optimization of aseptic processing technologies, including Open and Closed RABS systems.
Drive continuous improvement initiatives focused on equipment reliability, efficiency, throughput, and overall equipment effectiveness (OEE).
Participate in deviations, investigations, root cause analysis, CAPAs, and change management activities.
Ensure compliance with GMP, regulatory, safety, and engineering standards throughout all project phases.
Collaborate with Quality, Validation, Manufacturing, Maintenance, and Operations teams to ensure successful project delivery and ongoing operational performance.

QUALIFICATIONS AND REQUIREMENTS:  

Degree or Diploma in Mechanical Engineering, Manufacturing Engineering, or a related engineering discipline.
P.Eng designation or eligibility for professional registration is preferred.
Minimum 10 years of engineering and project management experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
Demonstrated experience leading capital projects, equipment installations, production line expansions, and facility retrofit initiatives.
Strong knowledge of aseptic filling, packaging, sterilization systems, and sterile manufacturing operations.
Experience working in GMP-regulated cleanroom environments, including contamination control, environmental monitoring, and Grade A/B aseptic processing.
Practical experience with Open and Closed RABS systems and aseptic manufacturing technologies.
Experience preparing and reviewing engineering documentation, including URS, qualification protocols, and validation deliverables.
Working knowledge of equipment qualification and validation activities including FAT, SAT, DQ, IQ, OQ, and commissioning.
Proficiency with AutoCAD, Microsoft Project, and Microsoft Office Suite.
Strong troubleshooting, problem-solving, project management, and cross-functional leadership skills.
Knowledge of GMP, FDA, ISO, and regulatory compliance requirements.
Experience working with OEMs, contractors, system integrators, and external vendors.
Familiarity with PLC-controlled systems, automation integration, and manufacturing process equipment is considered an asset.

Pay: $110,000.00-$145,000.00 per year

Benefits:

Casual dress
Company events
Company pension
Dental care
Disability insurance
Discounted or free food
Employee assistance program
Extended health care
Life insurance
On-site parking
Paid time off
Vision care
Wellness program

Ability to commute/relocate:

Arnprior, ON: reliably commute or plan to relocate before starting work (required)

Education:

Secondary School (preferred)

Experience:

engineering and project management: 10 years (required)
Aseptic technique: 1 year (required)

Work Location: In person

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