Job Description

Equipment and Systems Validation Specialist

PBE-Expert Inc 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, US-FDA 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 "

Pharmaceutical Validation Specialist

" 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.

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 1 to 5 years of professional or internship 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 (GANTT chart). Experience in engineering consulting (an asset).

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. Great challenges to overcome and skill capitalization. Ping pong competition during break hours. 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 whether it's based on ethnic origin, nationality, gender, identity, religion, age, disability, or any other identity parameter protected by Canadian law. Any person with a disability wishing to make a special request or accommodation will be invited to discuss it with their human resources and administrative management.

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Specialiste en validation pharmaceutique

Description de la compagnie:

PBE-Expert Inc., est une entreprise de conseil avec plus de 30 ans d'experience, dont l'expertise est largement reconnue et confirmee dans les secteurs pharmaceutiques, biotechnologies, chimie fine & API, hopitaux, et en industries alimentaire & du cannabis. Nous offrons des services GMP cle en main, en ingenierie des procedes, conformite, CQV (validation), CSV, AQ, calibration, gestion des projets, transfert technologique, developpement des layouts et suivi technique des installations.

Description du poste et responsabilites :

Le poste propose

Specialiste en validation pharmaceutique

sera amene a performer les taches suivantes :

Redaction de protocole de qualification d'installation

QI

: Vous redigerez des protocoles d'installation pour les equipements de production, des utilites propres, et des HVAC.

Redaction de protocole de qualification d'operation

QO

: Vous serez en charge de la redaction des protocoles d'operation des equipements de production, des utilites propres, et des HVAC.

Redaction de protocole de performance

: Enfin, vous redigerez des protocoles de performance des equipements de production, des utilites propres, et des HVAC, et ce, pour verifier et documenter que les equipements remplissent leurs fonctions et les performances prevues selon les URS.

Redaction de procedures d'operation SOP/MON

: Vous redigerez des procedures d'utilisation, de maintenance, de calibration, de nettoyage, pour de nouveaux equipements, incluant les procedures a suivre pour leur installation correcte et sure. Vous devrez egalement verifier que ces procedures sont respectees.

Le role du

specialiste en validation pharmaceutique

exige une excellente comprehension des principes d'ingenierie, de l'industrie pharmaceutique, ainsi que des competences solides en redaction selon les bonnes pratiques documentaires, et en communication.

Competences techniques requises & essentielles:

Qualification d'equipement pharmaceutique Redaction de protocole d'installation Redaction de protocole d'operation Redaction de protocole de performance Redaction de procedures, SOP/MON

Competences techniques optionnelles:

Validation du nettoyage Validation de sterilisation Validation du procede Validation informatique

Prerequis pour le poste :

Autorisation de travail au Canada de maniere non-restrictive et permanente Minimum 1 a 5 annees d'experience professionnelle ou de stage Connaissance des equipements de production, de fabrication et des systemes Bilinguisme en francais et anglais Diplome academique (minimum baccalaureat universitaire ou technique collegiale) dans l'un des domaines genie connexes suivants : genie chimique, mecanique, production automatisee, biologique, pharmacie, agro-alimentaire, etc.

Competences interpersonnelles & relationnelles:

Capacite a etre coache - Capacite d'argumenter et defendre ses idees Avoir un point de vue critique Prise d'initiative - Leadership - Communication - Travail d'equipe Capacite de prendre decision par rapport a instruction qu'on recoit Agile - etre capable de s'adapter au changement Accepter les nouveaux changements et realites organisationnelles Capacite de performance dans un environnement pouvant etre assujetti au stress ou a la pression Sens d'autonomie et d'auto-apprentissage Organisation personnelle et professionnelle Multi-tache et debrouillardise

Avantages a travailler chez PBE

Horaire de travail flexible. Conges feries. Formation en interne offerte aux employe(e)s par PBE-Expert Inc.*, reconnue par CPMT.
Implication dans des projets internationaux et locaux. Tres beaux defis a relever et capitalisation de competence. Competition au pingpong durant les heures de pause. Assurance medicament & dentaire offerte aux employes. Bonus selon performance par projet. Couverture de l'assurance professionnelle par PBE-Expert Inc.*
Evolution de carriere vers un poste de responsabilite et de gestion.

Diversite, equite et inclusion en matiere d'emploi:

PBE-Expert Inc. valorise la diversite, inclusion et equite en matiere d'emploi. PBE-Expert Inc. s'engage a creer un milieu de travail diversifie et inclusif. PBE-Expert Inc. offre un milieu sain aux employes afin qu'ils puissent avoir acces aux memes opportunites et chances de developpement professionnel et personnel. PBE-Expert Inc. s'engage a contrer la discrimination et intimidation en milieu d'emploi qu'elle soit basee sur l'origine ethnique, nationale, le sexe, l'identite, la religion, l'age, le handicap, ou tout autre parametre d'identite d'une personne, proteges par la loi canadienne. Toute personne en situation de handicap souhaitant presenter une demande speciale ou d'accommodement, sera invitee a discuter avec son responsable en ressources humaines et direction administrative.

Job Types: Full-time, Permanent

Pay: $55,000.00-$90,000.00 per year

Benefits:

Commuter benefits Company events Dental care Extended health care Life insurance On-site parking Paid time off Wellness program Work from home
Work Location: In person