Job Description

Validation Specialist - Technical Services Manufacturing Science
The validation specialist ensures products and processes are maintained in a validated state, compliant with regulatory and current Good Manufacturing Processes (cGMP) requirements, throughout their lifecycle. Provides leadership for all process and cleaning validation related activities and is responsible for continuing to build the level of validation knowledge across the site.
Functions, Duties, Tasks:
Primary Activities:
Owner of the process and cleaning validation programs at our company's Canada Prince Edward Island site.
Ensure that products and processes are maintained in a continuous validated state, providing technical leadership, and working directly with process teams to ensure accurate execution.
Maintain the site validation master plan and schedule, ensuring on-time execution of validation activities.
Work with manufacturing and quality teams to define and execute technical protocols, development activities, and technology transfer programs.
Participate in product and process related technical investigations and root-cause analyses of process deviations, complaints, and Out of Specification/ Out of Expectation events.
Prepare and provide critical review of validation documents, Process Flow Diagrams, batch records, Standard Operating Procedures, technical protocols, and reports.
Provide the necessary support in internal and external audits.
Train and develop validation support staff and enhance the level of validation knowledge at the site.
Demonstrate strict adherence to cGMP standards and our company's policies and procedures. Maintain "safety first and quality always" mindset.
Other duties as required.
Minimum Qualifications (education, experience and/or training, required certifications):
A Bachelor of Science degree in Engineering, Bio/Pharmaceutical Technology, Chemistry, Microbiology, or equivalent scientific degree.
Desirable MSc. or equivalent experience.
Minimum 3-5 years' validation experience in the pharma/biotech industry, with emphasis on process and cleaning validation
Proven understanding of biopharmaceutical production processes.
Broad knowledge of pharma/biotech validation, regulatory compliance, cGMP standards, and applicable international guidelines and regulations.
Demonstrated knowledge and experience in the practical and theoretical requirements of validation in a commercial cGMP manufacturing facility.
Proven success in leading multi-disciplinary project teams with excellent communication, problem-solving, and critical-thinking skills.
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
The Company is required to provide a reasonable estimate of the salary range for this job in certain provinces within Canada. Final determinations with respect to salary will consider a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education. Expected CAD salary range: $66,300.00 - $112,700.00. Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, and vacation.
All candidates are required to have adequate and legal work authorization to work in Canada, prior to applying for posted positions. Only candidates with valid work authorization, not requiring company sponsorship in the course of their employment with our company will be considered in the recruitment process.
Current Employees apply
Current Contingent Workers apply
Secondary Language(s) :
Specialiste Validation, Services techniques et production scientifiques.
Le specialiste de la validation veille a ce que les produits et les processus soient maintenus dans un etat valide, conforme aux exigences reglementaires et aux bonnes pratiques de fabrication actuelles (cGMP), tout au long de leur cycle de vie. Il fournit un leadership pour toutes les activites liees a la validation des processus et du nettoyage et est responsable de l'amelioration continue du niveau de connaissance en validation sur le site.
Fonctions, Devoirs, Taches :
Activites principales :
Proprietaire des programmes de validation des processus et de nettoyage sur le site de notre entreprise a l'Ile-du-Prince-Edouard, Canada.
Assurer que les produits et les processus sont maintenus dans un etat valide continu, en fournissant un leadership technique et en travaillant directement avec les equipes de processus pour garantir une execution precise.
Maintenir le plan directeur de validation du site et le calendrier, en veillant a l'execution dans les delais des activites de validation.
Travailler avec les equipes de fabrication et de qualite pour definir et executer des protocoles techniques, des activites de developpement et des programmes de transfert de technologie.
Participer aux enquetes techniques liees aux produits et aux processus ainsi qu'aux analyses des causes profondes des ecarts de processus, des plaintes et des evenements "Out of Specification/ Out of Expectation."
Preparer et fournir une revision critique des documents de validation, des "Process Flow Diagrams", des dossiers de lot, des procedures operatoires normalisees, des protocoles techniques et des rapports.
Fournir le soutien necessaire lors des audits internes et externes.
Former et developper le personnel de soutien a la validation et ameliorer le niveau de connaissance en validation sur le site.
Demontrer une stricte adhesion aux normes Bonnes pratiques de fabrication (cGMP) et aux politiques et procedures de notre entreprise. Maintenir une mentalite de securite d'abord et qualite toujours .
Autres taches selon les besoins.
Qualifications minimales (education, experience et/ou formation, certifications requises):
Baccalaureat en science, genie ou technologie bio/pharmaceutique, chimie, microbiologie ou un diplome scientifique equivalent.
Maitrise ou une experience equivalente est souhaitable.
Minimum de 3 a 5 ans d'experience en validation dans l'industrie pharmaceutique/biotech, avec un accent sur la validation des processus et du nettoyage.
Comprehension averee des processus de production biopharmaceutiques.
Large connaissance de la validation pharmaceutique/biotech, de la conformite reglementaire, des normes des bonnes pratiques de fabrication des lignes directrices et reglementations internationales applicables.
Connaissance et experience demontrees des exigences pratiques et theoriques de la validation dans une installation de fabrication commerciale de Bonnes pratiques de fabrication (cGMP).
Succes avere dans la direction d'equipes de projet multidisciplinaires avec d'excellentes competences en communication, en resolution de problemes et en pensee critique.
Nous sommes fiers d'etre une entreprise qui embrasse la valeur de rassembler des personnes diversifiees, talentueuses et engagees. La facon la plus rapide d'innover est de rassembler des gens de diverses opinions dans un environnement inclusif. Nous encourageons nos collegues a remettre en question avec respect les problemes de reflexion et d'approche de l'un et de l'autre. Nous sommes un employeur souscrivant au principe de l'egalite d'acces a l'emploi et nous sommes determines a favoriser un milieu de travail inclusif et diversifie.
L'entreprise doit fournir une estimation raisonnable de la fourchette de salaire pour ce poste dans certaines provinces du Canada. Les determinations finales concernant le salaire prendront en compte un certain nombre de facteurs, qui peuvent inclure, mais sans s'y limiter, le lieu de travail principal et les competences pertinentes, l'experience et l'education du candidat choisi. Echelle salariale attendue en CAD: $66,300.00 - $112,700.00. Les avantages disponibles comprennent l'eligibilite aux primes, des incitations a long terme le cas echeant, des avantages en matiere de soins de sante et d'autres assurances (pour l'employe et sa famille), des prestations de retraite, des conges payes et des vacances.
Tous les candidats doivent avoir une autorisation de travail adequate et legale pour travailler au Canada, avant de postuler les postes affiches.
Seuls les candidats disposant d'une autorisation de travail valide, ne necessitant pas de parrainage de l'entreprise pendant leur emploi dans notre organisation, seront pris en compte dans le processus de recrutement.
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation: No relocation
VISA Sponsorship: No
Travel Requirements: 10%
Flexible Work Arrangements: Not Applicable
Shift: 1st - Day
Valid Driving License: Yes
Hazardous Material(s): yes
Required Skills: Analytical Problem Solving, Cleaning Verification, Equipment Maintenance, Equipment Set Up, GMP Validation, Good Manufacturing Practices (GMP), Manufacturing Operations, Process Optimization, Protocol Writing, Teamwork, Technical Problem-Solving, Vaccine Production
Preferred Skills:
Job Posting End Date: 07/3/2025
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.