STERILE OPHTHALMIC CDMO

Careers at Pillar5 Pharma

Current Openings

Quality Compliance Associate (Permanent, Full - Time)

Reporting to the Manager of Quality Assurance

Responsibilities:

  • Batch record review:
    • Review batch documentation and reported analytical test results (as applicable) to ensure completeness and compliance to GMPs, SOPs, and other applicable requirements and assign appropriate disposition in the SAP system
    • Review documentation for incoming semi-finished goods and assign appropriate disposition in the SAP system
    • Proactively expedite releases in collaboration with other departments where possible to avoid backorders
    • Maintain plant metrics for Right First Time documentation
  • Provide back up to the Quality Control Manager to support appropriate disposition of raw materials, packaging materials and MRO items
  • Participate in Regulatory Inspections and Customer Audits as required
  • Initiate and participate in local product investigations
  • Create and maintain departmental SOPs relating to release activities, as required
  • Collaborate with Project Managers to establish documentation requirements for new products & product transfers
  • Coordinate Quality Systems (primary responsibility or acting as a back-up for the other Quality Compliance Associate)
    • Vendor Qualification process – assessing new Vendors and conducting external vendor audits as required
    • Supplier Quality Concerns – initiating and tracking supplier component defects and investigations
    • Product Complaint Handling - key contact for customers, initiating/reporting complaint investigations, final reporting to the customer, and any associated trending
    • Managing the Deviation and Change Control systems - including maintaining logs of closed/outstanding deviations and any associated trending
    • Annual Product Records Review scheduling and completion

Qualifications 

  • University degree in a relevant scientific discipline, or equivalent
  • Experience in pharmaceutical manufacturing in a quality role (minimum of 2 years)
  • Working knowledge of Good Manufacturing Practices, Good Laboratory Practices, and Regulatory Guidelines with several years of experience in the pharmaceutical industry
  • Proven leadership ability as evidenced by increasing responsibility in employment history
  • Ability to work effectively with regulatory agencies, contract manufacturers, external customers, technical and non-technical personnel
  • Knowledge of computerized information systems, including MS Office (notably MS Access) and SAP 

 

Application Process: Please send your resume by following below process


Aseptic Packing Area Material Handler (1 Full Time-Permanent Position)

Reporting to the APA Manager, the APA Material Handler/Blender’s role is to be responsible for the transport of job components/finished product to and from the Aseptic Processing Area, completion and review of files as well as all aspects of the blending process (including blending and sensitization of rooms/process pipes/tanks) in the APA.  The APA Material Handler/Blender interacts primarily with the following internal staff: Operators, Packagers, Set-up Mechanics, APA Team Leader/APA Manager, Warehouse, Chemistry Lab, Equipment Cleaners, Packaging Technician and Quality Assurance. 

Responsibilities:

  • Bring correct components to job site, ensure that additional components are issued as needed, and move finished product to the warehouse

Qualifications: 

  • Grade 12 Diploma
  • Good mathematical and mechanical skills
  • Good computer skills
  • Ability to follow written procedures and read schematic drawings
  • Excellent time management, organizational, interpersonal, problem solving and communication skills
  • Experience with fork-lift, SAP system, and Good Manufacturing Practices is an asset
  • Strong technical knowledge of aseptic processing and pharmaceutical packaging

Application Process:     Please send your resume by following below process



Quality Control Manager (1 Contract Position Available, 12-18 months)

We are currently recruiting for personnel interested in assuming the Quality Control Manager position on contract for a period of 12-18 months, providing oversight to the Quality Control activities of the site to ensure compliance with current Good Manufacturing Practices, Corporate Policies, and Customer requirements. This role reports to the Director of Quality Operations.

Responsibilities:

  • Technical expertise to validation projects & for resolving quality investigations
  • Secondary review of laboratory data to assure conformance to established procedure & accuracy
  • Monitor compendia, prepare analysis of changes and assure conformance
  • Monitor method updates issued by customers
  • Prepare supportive documentation for proposed changes to established specifications
  • Maintain necessary documentation and oversight of contract laboratories
  • Authorized Quality Authority alternate
  • Provide leadership & coaching, evaluate personnel performance, identify training needs & personnel development where required
  • Develop departmental operating plan (capacity planning and scheduling), monitor performance (productivity reporting), analyze variances to support the S&OP Supply Process and Site On Time Delivery targets
  • Lead and support Operational Excellence initiatives to support site goals

Qualifications: 

  • Bachelor of Science degree
  • 5 to 7 years supervisory/management experience, ideally in a Quality role in a pharmaceutical manufacturing environment
  • In-depth knowledge of GMP guidelines, quality systems and current HPFBI GMP and cGMP related policies and directives, as well as demonstrated experience in quality investigations
  • Analytical laboratory experience
  • Proven planning, organizational, and time management skills
  • High level of accountability and demonstrated leadership skills
  • Excellent communication, interpersonal, and customer service skills
  • Training or experience in operational excellence programs such as Six Sigma or LEAN are an asset
  • Proficiency in computer applications, specifically Microsoft Office and SAP

Application Process:     Please send your resume by following below process


Mechanic (Permanent, Full Time)

Reporting to the Manager of Maintenance Services, this role provides mechanical and maintenance services to the facility and the production areas to ensure continuous, safe and efficient production. This role is responsible for maintaining, repairing, and troubleshooting plant facilities and structures as well as production equipment as required in a pharmaceutical manufacturing site. 

Responsibilities:

  • Maintain, repair, set-up and operate equipment throughout the plant
  • Troubleshooting on a day-to-day basis
  • Work with contractors to ensure completion of maintenance tasks
  • Calibrate/install plant instrumentation
  • Follow written maintenance procedures according to preventative maintenance work orders

Qualifications: 

  • Recognized certificate/license as an industrial electrician/and or industrial millwright. Other relevant certification will be considered, multiple certifications an asset
  • Ability to read detailed drawings, both mechanical and electrical
  • Ability to troubleshoot mechanical and electrical systems
  • Knowledge of building systems (HVAC systems, boilers, purified water systems etc.)
  • Familiarity with automated equipment is a must
  • Experience with PLC controllers i.e. troubleshooting
  • Experience with AC/DC drive systems
  • Experience with equipment in the pharmaceutical industry would be an asset ( blending, tablet/capsule, blister forming)
  • Experience with maintenance software programs is an asset
  • Team player with a positive attitude; good written and oral communications
  • Ability to work shifts and be on call as required

Application Process:     Please send your resume by following below process


Senior Analyst, Technical Transfer (One, Permanent Full-Time Position)

Reporting to the Quality Systems Manager, the role of Senior Analyst, Technical Transfer is to support new product introductions and technical project activities. This will involve performing assessments for new Raw Material/ APIs, testing to pharmacopoeial (USP/ EP) standards or in-house methods, analytical method transfer exercise (AMTE) and supporting other Quality aspects of project work in an accurate, precise and timely manner by maintaining a clean and safe work environment. Analysis will be conducted according to the material’s specific test requirements and will entail the Senior Analyst, Technical Transfer’s knowledge and use of a variety of analytical instruments. The Senior Analyst, Technical Transfer is also responsible to actively participate and support Quality System improvement initiatives at Pillar5 Pharma Inc. 

Responsibilities:

  • Schedule and perform required chemical and physical tests on raw materials, semi-finished and finished goods, and stability samples in support of new product introduction/ technical project work
  • Quality representative on new product introductions/ technical project work teams
  • Collaboration with customers, development partner and contract testing laboratories
  • Prepares and analyze product samples in compliance with Good Laboratory Practices (GLP)
  • Prepare, operate and troubleshoot analytical instrumentation used for testing
  • Works independently and within teams to achieve department objectives
  • Interpret raw data and record test results in accordance with Good Documentation Practices
  • Open to continuous improvement initiatives and maintain innovator mindset 
  • Required to act as a back-up to QC Analysts on routine commercial product testing in support of base business requirements

Qualifications: 

  • University degree or college diploma in a relevant scientific discipline (chemistry preferred), with 5- to 10 years of laboratory experience, preferably in a pharmaceutical environment. (Other combinations of technical training and experience will be considered)
  • Proven and demonstrated knowledge of laboratory instrumentation (eg. HPLC, GC, FTIR, NIR, AA Spectroscopy, UV-VIS Spectroscopy) and methods (eg.USP/EP, in-house)
  • Demonstrated ability to work independently and as part of a team
  • Demonstrated planning, organizational, and time management skills
  • Experience in routine maintenance and troubleshooting of analytical instrumentation
  • Experience with GMP documentation and Data Integrity requirements
  • Experience with computerized laboratory instrumentation and computerized information systems
  • Experience in Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP)
  • Excellent communication and interpersonal skills

Application Process:     Please send your resume by following below process


Production Mechanic (2 Full Time-Permanent Positions)

We are looking for a creative, dynamic, customer and solution focused Production Mechanic to join our Packaging production Team. Reporting to the Manager, Packaging, you will be responsible to set up, modify, operate, troubleshoot and repair several different types of packaging machinery. 

Responsibilities:

  • Assemble, troubleshoot and operate a variety of filling, packaging and compression machines
    on a day-to-day basis
  • Diagnose malfunctions and determine the need for adjustment or repair
  • Perform and follow written set-up and maintenance on machines and equipment as per preventative maintenance schedule
  • Perform size-change on packaging lines and prepare them for a variety of product formats
  • Train operators on proper handling of equipment
  • Work with outside contractors to ensure completion of maintenance tasks and with other groups and trades personnel
  • Make recommendation and implement continuous improvement to equipment and processes

Qualifications: 

  • Grade 12 diploma, post secondary education with millwright certification is preferred
  • Minimum of 5 years progressive experience in a production environment preferably with packaging and tablet machines
  • Strong mechanical aptitude and proven mechanical training and experience with Programmable Logic Controllers (PLC) controllers i.e., troubleshooting
  • Excellent team work, organizational and interpersonal skills 
  • Demonstrated ability to handle multiple priorities in a fast paced environment
  • Understanding of cGMP’s and SOP’s
  • Understanding of Lean and Six Sigma concepts is an asset
  • Ability to work shifts and be on call when needed

Application Process:     Please send your resume by following below process


Production Mechanic (Aseptic Packaging Area) 1 Full Time-Permanent Position

We are looking for a creative, dynamic, customer and solution focused Production Mechanic to join our APA Team. Reporting to the Manager, APA, you will be responsible to set up, modify, operate, troubleshoot and repair several different types of packaging machinery. 

Responsibilities:

  • Assemble, troubleshoot and operate a variety of filling, packaging and compression machines
    on a day-to-day basis
  • Diagnose malfunctions and determine the need for adjustment or repair
  • Perform and follow written set-up and maintenance on machines and equipment as per preventative maintenance schedule
  • Perform size-change on packaging lines and prepare them for a variety of product formats
  • Train operators on proper handling of equipment
  • Work with outside contractors to ensure completion of maintenance tasks and with other groups and trades personnel
  • Make recommendation and implement continuous improvement to equipment and processes

Qualifications: 

  • Grade 12 diploma, post secondary education with millwright certification is preferred
  • Minimum of 5 years progressive experience in a production environment preferably with packaging and tabletting machines
  • Strong mechanical aptitude and proven mechanical training and experience with Programmable Logic Controllers (PLC) controllers i.e., troubleshooting
  • Excellent team work, organizational and interpersonal skills
  • Demonstrated ability to handle multiple priorities in a fast paced environment
  • Understanding of cGMP’s and SOP’s
  • Understanding of Lean and Six Sigma concepts is an asset
  • Ability to work shifts and be on call when needed

Application Process:     Please send your resume by following below process. 

The deadline for all applications is February 15, 2019.


Aseptic Packaging Area Group Leader (1 Permanent, Full-Time Position)

Reporting to the Manager of the APA, the APA Group Leader’s role is to work on the line, as well as coordinate and lead filling team members in an efficient manner to ensure that all production operations meet the production schedule. 

Responsibilities:

  • Ensures team members are in compliance with quality and safety requirements at all times
  • Works with APA Manager to resolve safety, quality and efficiency issues
  • Expedites receiving and delivery of materials and assists in RFT line clearances
  • Interacts primarily with the APA team and also with cross-functional teams such as Quality Operations, Engineering Services, Facilities and Maintenance, Materials Management and Purchasing
  • Ability to efficiently operate filling machines and manufacturing of blends
  • RFT and timely completion of production files

Qualifications:

  • Grade 12 diploma, post secondary education is preferred
  • Excellent oral and written communication skills
  • Minimum of 5 years progressive experience in a packaging environment, preferably in aseptic manufacturing and packaging
  • Computer literate with Microsoft Office programs and exposure to SAP
  • Demonstrated people management, coaching and leadership skills
  • Ability to work rotational shifts
  • Excellent organizational and interpersonal skills
  • Demonstrated ability to handle multiple priorities in a fast paced environment

Application Process:     Please send your resume by following below process. 

The deadline for all applications is Friday February 15, 2019.


Aseptic Packaging Area Operator (3 Permanent, Full-Time Positions Available)

Reporting to the Manager, APA, the APA operator’s role is to fill and package product in the most efficient manner while maintaining the highest degree of quality and aseptic practices. 

Responsibilities:

  • Operates various sterile filling equipment as required including basic trouble shooting skills
  • Operates other ancillary equipment as required
  • Able to conduct viable and non-viable EM sampling
  • Able to perform disinfection of the area as per SOPs
  • Able to perform other activities required to fill product aseptically (transfer of components, solution preparation, etc.)
  • Completes relevant documentation completely and accurately including microbiology documentation
  • Strictly adheres to Good Aseptic Practices, Standard Operating Procedures, safety guidelines and Good Manufacturing Practices during all aspects of this role
  • Conducts other duties as required, including alternate packaging duties within Manufacturing Operations

Qualifications:

  • Grade 12 diploma
  • Strong mechanical aptitude and mathematical skills
  • Able to multi-task and adapt to change
  • Demonstrated ability to work both independently and in a team environment
  • Excellent organization, interpersonal and communication skills
  • Proven ability to follow written procedures and complete accurate documentation
  • Strong working knowledge of Good Manufacturing Practices and a proven commitment to excellent product quality
  • Working knowledge of aseptic principles and experience working in a clean room or aseptic area is considered an asset
  • Capable of working all shifts and meeting the physical demands of this position, including extended periods of standing, reaching and lifting

Application Process:     Please send your resume by following below process. 

The deadline for all applications is Friday February 15, 2019.

 



Temporary Packager (Casual - On Call)

Responsibilities:

  • Inspects, packages and final packs product, ensuring quality standards are achieved
  • Maintains cleanliness of the packaging area as required
  • Completes relevant documentation completely and accurately
  • Strictly adheres to Standard Operating Procedures, safety guidelines and Good Manufacturing Practices in all aspects of the operation and cleaning of the area

Qualifications:

  • Grade 12 diploma
  • Ability to multi-task and adapt to change
  • Proven ability to follow written procedures and complete accurate documentation
  • Demonstrated ability to work both independently and in a team environment
  • Capacity to work all shifts and meet the physical demands of the position
  • Previous experience in a manufacturing environment would be an asset

Application Process:     Please send your resume by following below process

By mail to: Human Resources 365 Madawaska Blvd. Arnprior, Ontario K7S 0C9

By email to:
E-Mail: HR@pillar5pharma.com

Thank you for your interest, however, only applicants considered for an interview will be contacted. We are an equal opportunity employer. Upon request, accommodations due to a disability are available throughout the recruitment process. If you do not see an opportunity suited for you at this time, please check back soon. We are always looking for exceptional employees to become part of our team.

Our Conduct

Pillar5 believes that a company with integrity earns the confidence of its employees, customers, suppliers, shareholders and the community. 

Pillar5 adheres to the highest ethical standards in our corporate and business practices, in our dealings with employees, customers, suppliers and shareholders.

Pillar5 believes in and supports the principles of fairness and diversity and will not condone any behaviour that is construed as discriminatory or harassing.

Pillar5 strives to improve accessibility for our customers with disabilities. Customers who wish to review our Accessible Customer Service Policy or Accessibility Plan or who wish to provide feedback are welcome to contact us or to complete an onsite customer feedback form or can verbally do so to any Pillar5 Pharma employee.

Review our Policyour Plan, and our Feedback Form.

For off-site requests regarding accessibility, you may obtain a copy of Pillar5’s feedback form by contacting Human Resources at hr@pillar5pharma.com.