Join PBE Expert as a Pharmaceutical Engineering & Validation Specialist and contribute to high-impact projects. Apply your expertise in equipment qualification (IQ/OQ/PQ) within the pharmaceutical industry while benefiting from career growth and professional development opportunities.

PBE Expert is a leading Compliance Strategic Partner with over 30 years of experience, specializing in delivering high-quality & full Turnkey GMP services that ensure the achievement of EU-GMP Annex 1, US-FDA, Health Canada and EMA standards. From process & facilities engineering, CQV, validation, CSV & IT Validation, QA, GMP training, PAI, EPCMV (process engineering, construction management, validation), PBE is dedicated to delivering high-quality solutions for the pharmaceutical, biotech, Vaccine, Covid-19 and Life Science industries.

The position of "Specialist, Pharmaceutical Engineering & Validation " will be required to perform the following tasks:

Writing Installation Qualification "IQ" Protocol: You will draft installation protocols for production equipment, clean utilities, and HVAC systems.
Writing Operational Qualification "OQ" Protocol: You will be responsible for drafting operational protocols for production equipment, clean utilities, and HVAC systems.
Writing Performance Qualification Protocol: Finally, you will draft performance protocols for production equipment, clean utilities, and HVAC systems, to verify and document that the equipment fulfills its intended functions and performance criteria according to the URS.
Writing Standard Operating Procedures "SOP/MON": You will draft procedures for the use, maintenance, calibration, and cleaning of new equipment, including the procedures to follow for their correct and safe installation. You must also ensure that these procedures are adhered to.

Job Description and Responsibilities

The role of the Pharmaceutical Validation Specialist requires an excellent understanding of engineering principles, the pharmaceutical industry, as well as strong writing skills according to best documentation practices, and communication.

Required & Essential Technical Skills

Pharmaceutical equipment qualification
Installation protocol writing
Operation protocol writing
Performance protocol writing
Procedure writing, SOP/MON

Optional Technical Skills

Cleaning validation
Sterilization validation
Process validation
Computer system validation

Role Requirements

Unrestricted and permanent work authorization in Canada.
Minimum 5 years of professional experience.
Knowledge of production, manufacturing equipment, and systems.
Bilingualism in French and English (for Quebec roles).
Academic degree (minimum university bachelor's or technical college diploma) in one of the following related "engineering" fields: chemical, biotechnological, biopharmaceutical, food, mechanical, automated production, biological, pharmacy, agri-food, etc.
Membership in OIQ or CPI, or application process underway.
Mobility for overseas travel for international projects (rare).
Knowledge of CAD software such as AutoCAD.
Proficiency in MS-Project or equivalent (GANT chart).
Experience in engineering consulting.
Interpersonal & Relational Skills
Ability to be coached. Ability to defend ideas.
Having a critical viewpoint. Complex problem-solving capability.
Initiative taking. Leadership. Communication. Teamwork.
Decision-making ability based on received instructions.
Agility - ability to adapt to change.
Acceptance of new organizational changes and realities.
Ability to perform in an environment that may be subject to stress or pressure.
Sense of autonomy and self-learning.
Personal and professional organization.
Multitasking and resourcefulness.
Effective & professional customer service.

Benefits of Working at PBE

Rapid growth opportunities.
Career progression to a position of responsibility and management.
Competitive salary and benefits.
3 weeks of vacation from the start of employment and 3 sick days per year.
Advanced training provided by Health Canada Expert, MAPAQ Expert, Trainers accredited by CPMT & CIPE.
Access to our self-training libraries.
A stimulating and unconventional workplace that values work-life balance and encourages daily efficiency.
Free monthly lunch offered to employees.
Involvement in international and local projects.
Medication & dental insurance offered to employees.
Professional insurance coverage by PBE-Expert Inc.
Performance-based bonus per project.
Diversity, Equity, and Inclusion in the Workplace

PBE Expert Inc. values diversity, inclusion, and equity in employment. PBE Expert Inc. is committed to creating a diversified and inclusive workplace. PBE Expert Inc. offers a healthy environment for employees so they can have access to the same opportunities and chances for professional and personal development. PBE Expert Inc. is committed to countering discrimination and intimidation in the workplace.