Be better. Live better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. Pillar5 Pharma Inc. is recruiting for a critical position to continue our growth trajectory. We are looking for a Manager, Aseptic Operations, for our Operations team. Reporting to the Operations Executive, this role leads our Aseptic Filling Operations. You will have full responsibility for our multi-line aseptic production unit, leading a team of pharmaceutical production professionals to build high quality products for our world-class customer base.

RESPONSIBILITIES:

Delivery

• Ensures the execution of short- and long-term aseptic production plans.
• Ensures the manufacture of highest quality pharmaceutical products on schedule and according to all customer requirements and Pillar5 KPIs.
• Lead and inspire a diverse team of professionals to achieve operational excellence in the on-time delivery of products to our customer base.
• Proactively identify and address operational challenges to ensure smooth production.
• Drive initiatives to enhance profitability without compromising on quality and safety standards.
• Ensures that cGMP’s are used and followed during production of products so that all FDA and international regulations are met. Responds to monthly internal audit observations.
• Collaborate with cross-functional teams to analyze and troubleshoot complex manufacturing or process problems.

Continuous Improvement

• Implement effective problem-solving methodologies to resolve issues promptly and efficiently.
• Drive Lean and Continuous Improvement initiatives to enhance overall efficiency and quality.
• Promotes a continuous improvement environment by facilitating initiatives to improve Operational Excellence.
• Supports the use of Six Sigma and LEAN Manufacturing programs to improve product quality, reduce product cycle times, and improve product yields.

Culture and Leadership

• Foster a positive work environment that supports our corporate and departmental strategic initiatives – specifically the creation and a strong workplace culture.
• Provide mentorship and guidance to plant personnel for their personal and professional growth.
• Establish clear performance expectations and hold teams accountable for results.
• Effectively communicate organizational goals and objectives to the department.
• Supports all new product launches to ensure products are available according to targeting timelines.

QUALIFICATIONS:

• University degree in relevant scientific field (Microbiology strongly preferred)
• A minimum of 5 years of relevant experience in an aseptic manufacturing environment
• Experience working in a LEAN manufacturing environment
• Minimum of 5 years management experience
• Experience in filling, packaging, and validation technologies
• Thorough knowledge of Good Manufacturing Practices

Be better. Live better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. The position is responsible for the Engineering activities of the facility, supporting the operational processes of the existing business portfolio and lead the efforts for site and process expansion to support future company growth. You will lead a team of individuals focused on improving production rates, efficiencies, yields, and costs while maintaining or improving product quality.

RESPONSIBILITIES:

• Plan, direct, and operate capital projects, including capital budgets (ensuring procedures are in place to monitor performance against budgets)
• Leadership of Project Management initiatives to ensure successful execution of projects including new construction, renovations, and equipment installations
• Establishes and defines project requirements with management and internal customer groups
• Assume a lead role as technical expert on any company growth initiative that requires equipment/site modification and/or design
• Assists project sponsors with the preparation of Capital Appropriation Requests (CAR).
• Provides or arranges for development of complete design documentation
• Selects, manages, and coordinates the efforts of consultants/contractors to ensure successful delivery of engineering projects
• Develops Request for Proposal documents for design, construction, and major equipment items
• Administers and controls all design, construction and management contracts and financial issues
• Evaluate facility & utility capabilities for future upgrades

QUALIFICATIONS:

• Bachelor’s degree in Engineering
• 5-10 years of experience in maintenance management and engineering, ideally within the pharmaceutical, cosmetics, or consumer products industries
• Minimum 5 years of experience in maintenance leadership roles, including people management
• Proven experience in implementing and developing maintenance management systems
• Expertise in maintenance planning and strategy
• Demonstrated experience in leading capital projects from inception to completion
• Strong project management skills with a focus on execution and delivery
• Excellent interpersonal and leadership abilities
• Exceptional communication skills, both verbal and written

Be better. Live Better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. Pillar5 Pharma Inc. is seeking a Packager to join our Pharmaceutical Packaging department. As a Packager, you will play a crucial role in ensuring the safe and efficient packaging of pharmaceutical products.

RESPONSIBILITIES:

• Package pharmaceutical products according to established guidelines and procedures.
• Ensure accuracy and quality of packaging materials.
• Label and document packaged products correctly.
• Operate packaging equipment and machinery.
• Adhere to safety and regulatory standards.
• Collaborate with team members to meet production targets.
• Maintaining an organized and clean work environment to ensure safety and efficiency.
• Meet daily packing targets.
• Perform other duties as assigned by the supervisor or manager.

QUALIFICATIONS:

• High school diploma or equivalent
• Prior experience in pharmaceutical packaging preferred.
• Attention to detail and ability to follow instructions.
• Good manual dexterity and hand-eye coordination
• Ability to work in a fast-paced environment.
• Strong teamwork and communication skills.
• Knowledge of packing machines and tools is a plus.
• Good knowledge of GMP.

SCHEDULE:

• Days/Afternoons Rotating Shifts: Monday – Thursday (Days: 6:00am – 4:30pm & Afternoons: 4:00pm – 2:30 am).

Be better. Live better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. Reporting to the Manager, Formulations/Solid Dose Packaging and Formulations Supervisor. The Tab/Cap Operator follows master manufacturing documentation precisely to complete tablet compression / capsulation in accordance with standard operating procedures and good manufacturing practices. The Tab/Cap Operator is also required to complete all associated documentation in the batch record. The Tab/Cap Operator must be proficient in applicable computer systems to ensure the quality tracking of all associated materials and processed goods. There will be cross-training in other areas of Solid Dose Operations such as but not limited to Tablet Coating and Tablet Printing.

RESPONSIBILITIES:

• Operation of Fette tablet presses and ancillary equipment
• Cleaning Tablet presses and all associated equipment
• Assist in investigations and implement corrective solutions
• Complete all required documentation required for batch records
• Operation of the Accela Cota tablet coater/Tablet Printer
• Blending of coating solutions
• Cleaning Tablet Coater/Tablet Printer and all associated equipment

QUALIFICATIONS:

• High School Diploma
• Excellent fine motor, vision and mechanical skills
• Knowledge of statistical process control and Good Manufacturing Practices
• Knowledge of good machine safety practices
• Ability to meet the physical demands of the job and wear personal protective equipment as required
• Strong background in Lean Manufacturing concepts including SMED, 5S and OEE
• Excellent written and verbal skills
• Previous pharmaceutical experience is considered an asset
• Ability to work rotating shifts

Be better. Live Better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. The Tablet Coating/Printing Operator follows master manufacturing instructions precisely to complete tablet Coating and Printing in accordance with standard operating procedures and good manufacturing practices. It is also required to complete all associated documentation in the batch record. You must be proficient in applicable computer systems in order to ensure the quality tracking of all associated materials and processed goods.

RESPONSIBILITIES:

• Operation of the Accela Cota tablet coater.
• Operation of the Delta Tablet printing machine.
• Blending of coating solutions.
• Operation of all ancillary equipment to complete the coating and printing process.
• Cleaning of rooms and all associated equipment.
• Assist in investigations and implement corrective solutions.
• Complete all required documentation required for batch records.

QUALIFICATIONS:

• High School Diploma
• Excellent fine motor, vision, and mechanical skills.
• Knowledge of statistical process control and Good Manufacturing Practices.
• Knowledge of good machine safety practices.
• Ability to meet the physical demands of the job and wear personal protective equipment as required.
• Strong background in Lean Manufacturing concepts including SMED, 5S, and OEE.
• Excellent written and verbal skills.
• Previous pharmaceutical experience is considered an asset.
• Ability to work rotating shifts.

Be better. Live better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives The Supervisor, Microbiology, is responsible for supervising the Microbiology Laboratory, providing technical expertise, leadership, and training to the Microbiology team. The Supervisor, Microbiology applies technical skills in the training of the micro team members operations/process flow, prioritization, instrumentation, and troubleshooting, as well as in assessing new methodologies and procedures for method transfer. Providing quality laboratory results in a timely, accurate and efficient manner to ensure high-quality and safe products are produced for our customers. Creating a support environment that values success, supporting others in learning, promoting continuous improvement and preventing errors.  The Supervisor, Microbiology reports to the Manager, Microbiology and Sterility Assurance.

RESPONSIBILITIES:

• Responsible for prioritizing workload for laboratory analysts, schedule testing according to performance expectations, ensuring test sample results are reported in a timely manner to meet the customer requirements, as well as internal and external communication.
• Responsible for Microbiology Laboratory personnel training, evaluation, and approval of training records. Provide leadership and coaching to team members and identify training needs and development where required as well as participate in the assessment, hiring, and interviewing of Microbiology staff.
• Responsible for objective setting, managing performance, task allocation, training in microbiology laboratory procedures and contributing to audit readiness.
• Responsible for overseeing the operations of the microbiology laboratory, scheduling testing and overtime to meet production and shipping schedules.
• Responsible for microbiology analyst’s annual reviews.
• Acts as the Biosafety Officer for the CL-2 laboratory and maintains Public Health Agency of Canada requirements, training and license for CL-2 lab.
• Perform timely and effective Microbiology Laboratory Investigations (MLIR) for test results that are out-of-specification.
• Responsible to provide laboratory support for Sterility Assurance investigations.
• Responsible for the non-aseptic environmental monitoring program sampling and results.
• Responsible for the water system test results, read out, and annual trend reports.
• Responsible for notifying the Manager, Microbiology and Sterility Assurance of all non-conformance events that occur in the water system, NAPA and APA test results.
• Responsible for microbiology lab test results that include but are not limited to: Microbial Enumeration Test, GPT, MPT, water system test results, AET, antibiotic assays, biological spore assays and microorganism identification.
• Ensure excellent documentation controls, and capabilities are in place to maintain data integrity, and ensure timely and effective actions are taken.
• Participate and support customers and regulatory audits as a SME in Microbiology.
• Participate in internal audits, as well as maintaining and updating relevant microbiology laboratory SOPs.
• Review product specifications and test methods to current USP and customer requirements and propose appropriate updates.
• Assist Technical Services Team in Microbiological Validation studies by reviewing, providing technical expertise, and executing activities as required including data analysis and preparing reports.
• Identify areas for improvement and improve laboratory efficiency.

QUALIFICATIONS:

• Sc. in Microbiology is preferred. A B.Sc. in a related field will be considered with the appropriate experience.
• Minimum 5 years of hands-on experience working in a microbiology laboratory in a GMP facility and a CL-2 lab.
• Excellent planning, teamwork, organizational, interpersonal and communication skills (both written and verbal)
• Knowledge of microbiology laboratory techniques, identification systems (Biolog), equipment, and materials.
• Knowledge of computerized information systems, such as LIMS.
• Working knowledge of GMP, GLP, PHAC, HPFBI guidelines and safety guidelines. Knowledge in aseptic processing is an asset.
• Demonstrated problem solving skills with focus on Right First Time. Project leadership skills are an asset.

Be better. Live Better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. We are seeking to build its talent pool by hiring ambitious people to operate in our aseptic processing equipment lines. As an Aseptic Processing Operator, you will learn to produce ophthalmic pharmaceutical products in a manner that will ensure product safety for our customers.

RESPONSIBILITIES:

• Perform sterile gowning to allow for working in the aseptic cleanrooms.
• Set up and operate bottle filling machines in a slow and deliberate manner, including the ability to set up outside filling equipment.
• Perform routine maintenance and troubleshooting on equipment to ensure optimal performance.
• Monitor production processes and adjust as necessary to maintain product quality and efficiency.
• Follow standard operating procedures (SOPs) and safety guidelines to maintain a safe and clean work environment.
• Document production activities and maintain accurate records of materials used and products produced.
• Collaborate with team members and supervisors to meet production targets and deadlines.

QUALIFICATIONS:

• Prior experience in a manufacturing or production environment is an asset.
• Strong attention to detail and ability to follow instructions accurately.
• Strong mechanical aptitude and mathematical skills.
• Proven ability to complete accurate documentation.
• Ability to work effectively in a fast-paced and team-oriented environment.
• Good communication skills and ability to collaborate with colleagues.
• High school diploma or equivalent. Any courses taken in biology/microbiology is an asset.
• Capable of working all shifts, days, evening and weekend
• Meeting the physical demands of this position, i.e. Standing up to 10-hours per shift

SCHEDULE:

• Days/Afternoon (10 Hour Shifts) Weekly Rotating Shifts: Monday – Thursday

Be better. Live better. That’s our vision at Pillar5 Pharma. We are a pharmaceutical manufacturing company that makes products people use in their everyday lives. Reporting to the APA Fill Supervisor the Material Handler/Blender minimizes downtime through material handling and turnovers.  Through trouble shooting, problem solving and follow-up, the role ensures continuous, safe, and efficient production in all processes.

RESPONSIBILITIES:

• Issue and/or verify bulk and component to APA jobs
• Calculates yields and accountabilities of finished goods including SAP transactions
• Returns and initiates APA jobs investigation reports
• Brings correct components to job site, ensures that additional components are issued as needed, moves finished product to the warehouse, and provides material handling duties for other areas as required
• Completes job turnovers and component accountabilities, ensuring the completion of all documentation
• Monitors all supplies for availability and expiry dates and places orders when required
• Conduct lot/expiry and label verification, and other documentation reviews.  Conducts verification of packaging jobs issued
• Expedites line clearances, materials delivery, and equipment set-up, working with support teams as required
• Ensures that quality issues and investigations are handled immediately and appropriately
• Performs CIP washes, prepares blends for filling, conducts microbiological and chemistry sampling, assists with utility and APA operations as directed, transfers components, cleans production areas, and carries out other duties as trained and required.
• Follows and updates SOPs as required

QUALIFICATIONS:

• High School diploma
• Good mathematical, mechanical and computer skills
• Able to work shifts and meet the physical demands of this position
• Ability to follow written procedures and read schematic drawings
• Excellent time management, organizational, interpersonal, problem solving and communication skills
• Strong technical knowledge of aseptic processing and pharmaceutical packaging
• Experience with fork-lift, SAP system and/or inventory tracking systems, and Good Manufacturing Practices is a must

SCHEDULE

• Monday – Friday (Weekdays)