Technician, Operations, Fermentation / Technicien(ne), Opérations, Fermentation

Merck; Charlottetown; On-site; CAD 50,000 - 75,000; Full time

Benefits offered by this job

Discretionary incentive plan

Flexible benefits

Job summary

Merck in Charlottetown, PEI, is seeking a Technician for the Fermentation Department to support antigen production and vaccine manufacture in our Animal Health facility.

You will follow cGMP, prepare materials, complete documentation, and assist with environmental monitoring and equipment readiness, working 12-hour shifts and with potential overtime.

Qualifications

• 2-year biotechnology diploma required; Bachelor's degree in life sciences preferred.
• 1-3 years of GMP bio-manufacturing experience.
• Experience with fermentation in a cGMP environment.
• Experience in SOPs and batch records per GMP.

Responsibilities

• Comply with safety requirements, cGMP, SOPs and manufacturing documentation.
• Produce antigens and vaccines according to approved production outlines and cGMP guidelines.
• Support antigen production and freeze-dried vaccines per SOPs and protocols.
• Complete environmental monitoring (viable and non-viable).
• Prepare materials for production needs and ensure readiness of equipment and materials.
• Maintain cleanliness of production areas and assist in disinfection procedures.
• Use SAP for material consumption and local systems used in production.

Skills

GMP bio-manufacturing

Fermentation experience

SOP writing

Batch records

MS Office

Communication skills

Regulatory knowledge

Education

2-year biotechnology diploma

Bachelor's degree in life sciences

Tools

SAP

Job description

This Technician position is within the Fermentation Department at our Animal Health facility in Charlottetown Prince Edward Island. The Charlottetown facility manufactures vaccines and biologics used within aquaculture farming.

Leveraging an experienced and innovative team environment, the key technologies at the site are biologics production using fermentation, tangential flow filtration, chromatography, cell culture platforms, and sterile filling.

The Charlottetown facility is part of our global Animal Health Manufacturing Division network and is a key contributor to the manufacturing of animal health products. Working within one of the manufacturing operations teams you will be expected to be able to work independently and as part of the team to contribute to the daily completion and schedule adherence of production activities.

The Nucleic Acid Vaccine (NAV) manufacturing operation is made up of teams that carry out the production activities for the preparation of equipment, buffers and media components, fermentation of bacteria, downstream processing of plasmid DNA and blending of the final vaccines prior to sterile filling.

The position requires someone who can demonstrate a good attention to detail and achieve a consistent error-free execution of daily job responsibilities, be able to complete documentation using Good Documentation Practices and be able to identify opportunities for process improvement and employ basic problem-solving skills.

Functions, Duties, Tasks

• Comply with safety requirements, cGMP, SOP, and manufacturing documentation.
• Produce antigens in a timely manner according to their approved Outline of Production/Product Dossiers and to cGMP guidelines.
• Support Antigen production and freeze-dried vaccines production according to standard operating procedures and protocols.
• Complete environmental monitoring, both viable and non-viable monitoring.
• Prepare materials for production needs.
• Organizing, labeling, wrapping and sterilization of materials.
• Ensure equipment and materials are in state of readiness for production technicians.
• Maintain cleanliness of the production areas and assist in disinfection procedures, clean, and sterilize items used in production
• Assist in media preparation and other supporting activities
• Perform routine activities such as recording temperatures and room pressures, performing purified water sampling and clean steam sampling.
• Support fermentation operator by cleaning fermenters and associated parts, set up/tear down of fermenters.
• Preparation and modification of standard operating procedures as required.
• Use SAP system for material consumption and other local computerized systems used in production.
• Other duties as required.

Minimum Qualifications

• A 2-year biotechnology diploma is required; a Bachelor's degree in life sciences (e.g., Biochemistry, Chemistry, Chemical Engineering, Biology) is preferred.
• 1-3 years of experience in the GMP bio-manufacturing industry.
• Experience with fermentation in a cGMP Manufacturing environment.
• Experience in the preparation of standard operating procedures, preparation of batch records as per specific GMP requirements.
• Excellent interpersonal skills, both communications and written.
• Outlines of Production, cGMP guidelines, and HSE regulations.
• Experience performing investigations and writing deviations.
• Intermediate/Expert computer skills using MS Office (Word, Excel, Power Point).
• Thorough technical understanding of quality systems and regulatory requirements.

Other Information

• Must be able to work 12-hour shifts (12-hour daytime shifts, 3-4 days/week including some weekends) and overtime as required.
• Must be able to wear clean room garments and remain in clean room area for up to 3 hours at a time.
• Required to assist in disinfection procedures involving hazardous chemicals requiring the use of a respirator.
• Must be able to lift, move and maneuver small-medium sized equipment - up to 50lbs.
• Requires ability to stand for long periods of time.
• Requires frequent ladder or stair climbing.
• Must be able to read, write, understand, and comply with appropriate standard operating procedures.

This job posting is for an existing vacancy position.

The anticipated base salary range for this position is $50,160.00 - $75,240.00 CAD. At our company, we are firmly committed to provide fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual employee salaries will be based on several factors such as relevant experience, skills & proficiency, and/or other bona fide factors relative to appropriate internal comparators.

At our Company, we lead with people. This role includes eligibility to our discretionary short-term-incentive plan which fosters a pay-for-performance culture. Also, our contemporary rewards and benefit programs go beyond traditional medical plans and retirement programs, to create a flexible, inclusive workplace to