Senior GMP Operator

Optimi is a Canadian Good Manufacturing Practices (GMP) compliant pharmaceutical drug manufacturer licensed by Health Canada for the handling of controlled substances and GMP production. The focus of the company is on pharmaceutical-grade psychedelics, including MDMA and naturally derived psilocybin products. From facilities in Princeton, British Columbia and operating under a Drug Establishment License from Health Canada, Optimi supplies active pharmaceutical ingredients and finished dosage forms to regulated channels, with products currently in market for prescription use in Australia via the Authorized Prescriber Scheme and clinical trials in Israel, as well as accessible in Canada through the Special Access Program. Optimi also has an active Cannabis Analytical Testing License through Health Canada. We are seeking a highly motivated and experienced Senior GMP Operator to join our manufacturing team at Optimi Health. The successful candidate will execute GMP manufacturing operations across our product lines, operate and maintain production equipment, and act as a hands-on technical resource during process scale-up and validation activities. This role requires a strong working knowledge of GMP principles, meticulous documentation practices, and the ability to troubleshoot equipment and process issues on the production floor. Responsibilities: 1. GMP Manufacturing Operations: Execute batch manufacturing steps (e.g., grinding, extraction, filtration, drying, blending, sampling, and packaging) in strict accordance with approved Master Batch Records (MBRs) and Standard Operating Procedures (SOPs) Perform in-process checks and record critical process parameters (CPPs) accurately and in real time Identify, document, and escalate deviations, out-of-specification results, and process anomalies promptly to Quality Assurance and Manufacturing leadership Support line clearance, batch changeover, and cleaning activities to maintain GMP-compliant production areas Perform and/or oversee sanitation of manufacturing areas, equipment, and utensils in accordance with approved cleaning SOPs, sanitation schedules, and GMP requirements 2. Equipment Operation & Maintenance: Set up, operate, calibrate, and troubleshoot production equipment (e.g., grinders, extraction/sonication systems, blenders, drying units) safely and in accordance with equipment SOPs Perform routine preventive maintenance and coordinate with Engineering/Maintenance on equipment repairs, qualification, and requalification activities Complete equipment logbooks, cleaning records, and use logs accurately and on time Recommend equipment or process improvements to enhance efficiency, safety, and product quality 3. Scale-Up & Process Support: Act as a hands-on technical resource during process scale-up, tech transfer, and process validation runs Support execution of validation protocols and provide floor-level observations to help refine critical process parameters (CPPs) and critical quality attributes (CQAs) Collaborate with Quality, R&D, and Engineering teams to troubleshoot process issues identified during scale-up Provide input on batch record and SOP revisions based on hands-on production experience 4. Documentation & Compliance: Complete GMP documentation (batch records, logbooks, deviation reports, change controls) with a high standard of data integrity and attention to detail Own and lead deviation and CAPA (Corrective and Preventive Action) investigations related to manufacturing, including root cause analysis, impact assessment, and verification of corrective action effectiveness Maintain current training on applicable SOPs, safety procedures, and regulatory requirements Participate in internal audits and regulatory inspections as required, representing manufacturing operations Adhere to all Health Canada GMP requirements and site Good Documentation Practices (GDP) 5. Training & Mentorship: Provide on-the-job training and mentorship to junior GMP Operators on equipment operation, GMP practices, and documentation standards Act as a designated backup/alternate for other qualified roles under GMP as assigned Contribute to the development and refinement of training materials and on-boarding documentation Key Requirements: To be successful in this role, the ideal candidate should possess the following qualifications and skills: Education: High school diploma or equivalent required; an undergraduate degree in a science-related field (e.g., chemistry, biology, chemical technology) is preferred Experience: Minimum 3-5 years of hands-on experience in a GMP-regulated manufacturing environment (pharmaceutical, natural health products, cannabis, or similar), with prior experience operating process equipment Demonstrated experience supporting process scale-up, tech transfer, or validation activities is strongly preferred Prior experience acting as a trainer, lead hand, or mentor to other operators is an asset Skills & Certifications: Strong working knowledge of GMP principles, Good Documentation Practices (GDP), and batch record execution Mechanical aptitude and comfort operating, troubleshooting, and performing basic maintenance on production equipment High attention to detail and strong accuracy in documentation, calculations, and data recording Ability to read, interpret, and follow detailed SOPs, batch records, and validation protocols Strong communication and teamwork skills, with the ability to collaborate across Manufacturing, Quality, and Engineering Comfortable working with basic computer systems/software for documentation and record-keeping Physical ability to stand for extended periods, lift up to 25 kg, and wear required PPE/cleanroom gowning Additional Responsibilities: In addition to the primary responsibilities, the Senior GMP Operator may be required to perform the following duties: Participate in continuous improvement initiatives, equipment qualification projects, and cross-functional process improvement teams Support inventory management and material handling for production supplies, in-process materials, and finished products, in accordance with GMP material control requirements Act as a qualified alternate for other designated GMP production roles as identified in the site's alternate personnel matrix (e.g., Grinding/Extraction Operator, Drying/Blending Operator) Optimi Health is a small, growing organization; the Senior GMP Operator may be required to support other areas of the business as needed and is expected to contribute flexibly across teams to help the company meet its operational goals Compensation Annual Salary of $80,000 - $90,000 3 weeks of annual vacation Comprehensive benefits package – including medical, dental, vision Relocation and accommodation support provided Only candidates who are Canadian citizens or possess valid authorization to work in Canada will be considered. Please note that we do not provide visa sponsorship for this position and any applications from candidates without existing work authorization will not be considered. While we appreciate all those who apply, only those selected for interview will be contacted.

Execute GMP manufacturing operations and maintain production equipment in accordance with Master Batch Records and SOPs. Provide technical support for process scale-up, validation activities, and mentorship for junior operators.

Requires 3-5 years of experience in a GMP-regulated environment and a high school diploma, though a science degree is preferred. Must possess strong mechanical aptitude and a deep understanding of Good Documentation Practices.

• Medical Insurance • Dental Insurance • Vision Insurance • 3 Weeks Annual Vacation • Relocation Support • Accommodation Support

• Root Cause AnalysisPreferred

Identified from the job description. Confirm important requirements above.

• GMP Manufacturing
• Good Documentation Practices
• Equipment Troubleshooting
• Process Scale-Up
• Batch Record Execution
• CAPA Investigations
• Root Cause Analysis
• Process Validation
• Technical Mentorship
• Sanitation Procedures
• In-process Checks
• Mechanical Aptitude

• Manufacturing
• Healthcare
• Science & Research
• Engineering

Minimum education

High school

Minimum experience

2+ years

Apply by

Feb 27, 2027

Posting language

English

Working hours

40 hours per week

Seniority

Mid-Senior level

Application method

Direct apply is available