Job Description:
To support in the production process of veterinary biologics according to a defined production schedule following cGMP guidelines and specific Outlines of Production to meet market demands for aquaculture products.
Main Responsibilities and Duties
GMP Responsibilities:
- Review and approve completed batch records to ensure production records are evaluated and signed by an authorized person.
- Ensure facilities, equipment, and production areas remain in a qualified, validated, calibrated, and well-maintained state, including oversight of cleaning, maintenance activities, and associated records.
- Maintain plant hygiene standards and review relevant documentation, including logbooks.
- Ensure all team members receive and maintain required GMP training, including approval of instructor-led and on-the-job training (OJT).
- Ensure timely communication and escalation of quality issues through established processes.
- Initiate, classify, investigate, and document Reliance Events, serving as Lead Investigator when required.
- Act as Change Manager for changes impacting the department and ensure compliance with change control procedures.
- Prepare and revise GMP documentation including SOPs, master batch records, batch records, and other controlled documents.
- Ensure compliance with applicable GMP regulations, quality standards, and site requirements.
- May be delegated responsibility to temporarily perform the duties of the Operations Manager (IPT).
- Participate in required medical assessments in accordance with GMP regulations and site requirements.
Operations Responsibilities:
- Promote and model a "Safety First, Quality Always" culture and ensure compliance with all company safety, quality, cGMP, SOP, and manufacturing requirements.
- Ensure products are manufactured according to approved product dossiers and production requirements to meet business and market demands.
- Maintain a strong shop floor presence and provide leadership through technical expertise, problem-solving, continuous improvement, and process optimization.
- Act as the facility owner for assigned areas, taking accountability for operational performance and activities.
- Support production planning by providing input to schedules, monitoring execution, and tracking adherence.
- Manage shift coverage, short-term absences, attendance tracking, and workforce allocation.
- Conduct regular one-on-one meetings, performance evaluations, coaching, mentoring, and development discussions with direct reports.
- Build and maintain training plans to ensure work is performed by trained and qualified personnel.
- Ensure accurate and timely completion, review, and approval of production documentation, including batch records and SAP transactions such as material consumption.
- Investigate operational events using structured root cause analysis methodologies and document findings in Reliance.
- Implement operational improvements and minor process changes through established change control procedures.
- Provide input into User Requirement Specifications (URS) and support capital projects as required.
- Facilitate daily Tier 1 meetings and support Tier 2 management processes, including updating performance boards and facilitating meetings when required.
- Escalate significant operational issues and proposed solutions to the Operations Manager (IPT).
- Perform other duties as assigned.
Minimum Qualifications
Education:
- College Diploma in a Life Science discipline such as Biochemistry, Chemistry, Biology, Chemical Engineering, or Biochemical Engineering preferred.
Experience:
- 3 to 5 years of experience in a manufacturing environment; GMP experience preferred.
- Experience in aseptic fill/finish manufacturing preferred.
- Previous supervisory or people leadership experience preferred.
- Experience conducting investigations, writing deviations, CAPAs, SOPs, and other GMP production documentation.
- Strong understanding of quality systems, cGMP requirements, and regulatory expectations.
Technical Skills:
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
- Experience with SAP or other ERP systems preferred
- Strong written and verbal communication skills
- Excellent interpersonal and collaboration skills
Additional Requirements:
- Must be available on-call up to 12 hours per day, 7 days per week for emergency situations.
- Must be able to read, write, understand, and comply with applicable standard operating procedures.
This job posting is for an existing vacancy position .
We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.
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.
We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.
Required Skills:
Adaptability, CNC Manufacturing, Computer Literacy, Fabrication Processes, Good Manufacturing Practices (GMP), Inventory Management, Machinery Operation, Material Selection, Operational Efficiency, Process Improvements, Production Planning, Production Scheduling, Safety Protocols, Teamwork, Technical Problem-Solving
Preferred Skills:
Current Employees apply HERE
Current Contingent Workers apply HERE
Secondary Language(s) Job Description:
Support the production process of veterinary biologics according to a defined production schedule, in compliance with cGMP guidelines and established production protocols, to meet market demand for products intended for aquaculture.
Main Responsibilities and Duties
GMP Responsibilities (Good Manufacturing Practices):
- Review and approve completed batch records to ensure production records are evaluated and signed by an authorized person.
- Ensure facilities, equipment, and production areas remain qualified, validated, calibrated, and properly maintained, including oversight of cleaning and maintenance activities and the associated documentation.
- Maintain plant hygiene standards and review relevant documentation, including logbooks.
- Ensure all team members receive and maintain the required GMP training, including approval of classroom training and on-the-job training (OJT).
- Ensure prompt communication and escalation of quality issues in accordance with established processes.
- Initiate, classify, investigate, and document Reliance events, acting as lead investigator when required.
- Act as change manager for changes affecting the department and ensure compliance with change control procedures.
- Prepare and revise GMP documentation, including standard operating procedures (SOPs), master batch records, batch records, and other controlled documents.
- Ensure compliance with applicable regulatory requirements, quality standards, and site requirements.
- May be temporarily delegated the responsibilities of the Operations Manager (IPT).
- Take part in medical assessments required under GMP regulations and site requirements.
Operational Responsibilities:
- Promote and embody a culture of "Safety First, Quality Always" and ensure compliance with all safety, quality, cGMP, SOP, and manufacturing requirements.
- Ensure products are manufactured in accordance with approved product registration files and production requirements to meet business and market needs.
- Maintain an active presence on the production floor and provide leadership based on technical expertise, problem-solving, continuous improvement, and process optimization.
- Act as facility owner for assigned areas, taking responsibility for operational activities and performance.
- Contribute to production planning by taking part in scheduling, monitoring execution, and tracking adherence to the timetable.
- Manage shift coverage, short-term absences, attendance tracking, and resource allocation.
- Hold regular one-on-one meetings, performance reviews, and coaching, mentoring, and development activities with employees under their responsibility.
- Develop and maintain training plans to ensure activities are carried out by qualified and competent personnel.
- Ensure accurate and timely execution, review, and approval of production documentation, including batch records and SAP transactions such as material consumption.
- Investigate operational events using structured root cause analysis methods and document findings in Reliance.
- Implement operational improvements and minor process changes in accordance with change control procedures.
- Contribute to the preparation of User Requirement Specifications (URS) and support capital projects when required.
- Lead daily Tier 1 meetings and support Tier 2 management processes, including updating performance boards and leading meetings as needed.
- Escalate significant operational issues and proposed solutions to the Operations Manager (IPT).
- Perform any other related duties as required.
Minimum Qualifications
Education:
- College diploma (DEC) in a life science discipline such as biochemistry, chemistry, biology, chemical engineering, or biochemical engineering, preferred.
Experience:
- 3 to 5 years of experience in a manufacturing environment; GMP experience preferred.
- Experience in aseptic manufacturing (sterile filling and finishing) considered an asset.
- Prior supervisory or people management experience considered an asset.
- Experience conducting investigations and writing deviations, CAPAs, SOPs, and other GMP-compliant production documents.
- Good understanding of quality systems, cGMP requirements, and regulatory expectations.
Technical Skills:
- Proficiency with Microsoft Office (Word, Excel, PowerPoint)
- Experience with SAP or another ERP system, an asset
- Excellent written and verbal communication skills
- Excellent interpersonal skills and ability to work collaboratively
Additional Requirements:
-
Must be available on call up to 12 hours a day, 7 days a week, to respond to emergency situations.
-
Must be able to read, write, understand, and apply standard operating procedures (SOPs) and other applicable procedures.
This job posting is for an existing vacancy.
We may use artificial intelligence and automated tools to support our recruitment process. These tools are used to support, not replace, human judgment. All hiring decisions are made by our hiring managers.
We are proud to be a company that values bringing together diverse, talented, and committed people. The fastest way to foster innovation is to bring diverse ideas together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's views and solve problems collectively. We are an equal opportunity employer committed to fostering an inclusive and diverse workplace.
We encourage applications from all qualified candidates. In accordance with our accommodation policies and applicable provincial and federal accessibility legislation, we are committed to providing reasonable accommodation throughout the recruitment process.
This job posting is for an existing vacancy position.
The Primary location for this role is
CAN - Prince Edward Island - Charlottetown
The anticipated base salary range for this position is listed below. This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. At our company, we are firmly committed to providing fair and equitable pay for similar work and experience as a fundamental aspect of our workplace culture. Individual salaries will be based on several factors such as relevant experience, skills and proficiency, and other bona fide factors relative to appropriate internal comparators.
We may use artificial intelligence and automated tools to support our recruitment process. AI tools are used to support, but not replace, human judgment. All hiring decisions are made by our hiring managers.
At our Company, we lead with people. This role includes eligibility for our discretionary short-term incentive plan, which fosters a pay-for-performance culture. Our rewards and benefits programs go beyond traditional medical plans and retirement programs to create a flexible, inclusive workplace that supports employee well-being, development, and long-term success.
Additional location(s): Please note the base salary range above applies to the Primary Location of the position role, including where the role is designated as remote but tied to the Primary Location for compensation purposes. Where a role has other listed locations, different compensation guidelines may apply. You may find the base salary ranges for additional locations below. If the base salary range is not listed for the location to which you are applying, our Talent Acquisition team may provide further information about compensation applicable to your location, where required by law.
Additional location(s) Compensation Information:
$66,800 - $100,320
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:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving LIcense:
No
Hazardous Material(s):
Yes
Job Posting End Date:
11/25/2026
*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.