Equipment and Systems Validation Specialist
Top Benefits
About the role
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.
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 chn
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.
About PBE Expert
PBE is a Canadian leading consulting company specializing in cGMP compliance to federal and provincial regulations, in Biotech, Pharma, Vaccine, & Life Science industries.
Since 2007, PBE has empowered scientists, engineers, revolutionaries and facility owners to make their goals come true in an ever-changing world. Founded in 2013, PBE Expert (Pharma Bio Expert) has quickly emerged as a leader in delivering comprehensive EPCMV Turnkey projects, encompassing services such as Engineering, Quality Assurance, Validation, and PAI. Our focus is primarily on life science, biotech, vaccine, and pharmaceutical sectors. With more than 30 years of collective experience, we have successfully executed over 300 GMPCMV pharmaceutical projects across a broad spectrum of areas including Fill & Finish (F&F), Biotechnology, Vaccines, Intravenous solutions (IV), Solid Dosage Forms (SV), High Volume Parenteral (HV), Single-Use Systems (SU), Pre-filled Syringes (PFS), Blow-Fill-Seal (BFS), Sterile, Oncological, and Oral Solid Dosage (OSD).
We understand that ensuring compliance can be a really challenging and complex process, especially in the pharma and biotech industries, however it is critical to ensure the safety and effectiveness of products.
PBE has Health Canada, US-FDA, EMA and MAPAQ (Ministère de l'Agriculture, des Pêcheries et de l'Alimentation du Québec) SME Experts within their team.
OUR APPROACH We work with our clients for the long-term, taking the time upfront to understand their business and workforce requirements to ensure commercial outcomes are achieved. CPMT certified, we hire and train the top talent in the pharmaceutical industry, to build a strong team of SME (Subject Matter Experts) with the skills you need to achieve your goals with peace of mind.
Key Services: Facility Engineering, Validation (pharmaceutical), CQV, QA, GMP Design, RCA & Investigations, CAPA, PM, Procurement, pre-approval inspections & more.
Visit www.pbe-expert.com
Equipment and Systems Validation Specialist
Top Benefits
About the role
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.
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 chn
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.
About PBE Expert
PBE is a Canadian leading consulting company specializing in cGMP compliance to federal and provincial regulations, in Biotech, Pharma, Vaccine, & Life Science industries.
Since 2007, PBE has empowered scientists, engineers, revolutionaries and facility owners to make their goals come true in an ever-changing world. Founded in 2013, PBE Expert (Pharma Bio Expert) has quickly emerged as a leader in delivering comprehensive EPCMV Turnkey projects, encompassing services such as Engineering, Quality Assurance, Validation, and PAI. Our focus is primarily on life science, biotech, vaccine, and pharmaceutical sectors. With more than 30 years of collective experience, we have successfully executed over 300 GMPCMV pharmaceutical projects across a broad spectrum of areas including Fill & Finish (F&F), Biotechnology, Vaccines, Intravenous solutions (IV), Solid Dosage Forms (SV), High Volume Parenteral (HV), Single-Use Systems (SU), Pre-filled Syringes (PFS), Blow-Fill-Seal (BFS), Sterile, Oncological, and Oral Solid Dosage (OSD).
We understand that ensuring compliance can be a really challenging and complex process, especially in the pharma and biotech industries, however it is critical to ensure the safety and effectiveness of products.
PBE has Health Canada, US-FDA, EMA and MAPAQ (Ministère de l'Agriculture, des Pêcheries et de l'Alimentation du Québec) SME Experts within their team.
OUR APPROACH We work with our clients for the long-term, taking the time upfront to understand their business and workforce requirements to ensure commercial outcomes are achieved. CPMT certified, we hire and train the top talent in the pharmaceutical industry, to build a strong team of SME (Subject Matter Experts) with the skills you need to achieve your goals with peace of mind.
Key Services: Facility Engineering, Validation (pharmaceutical), CQV, QA, GMP Design, RCA & Investigations, CAPA, PM, Procurement, pre-approval inspections & more.
Visit www.pbe-expert.com