Maintenance Mechanic L2

Bora Pharmaceuticals•Mississauga, ON

11d•Onsite

About The Position

Bora Bora Pharmaceuticals is a premier international contract development and manufacturing organization (CDMO) specializing in formulation development, clinical and commercial manufacturing, and packaging of complex oral solid dose, liquid, semi-solid, biologics, and sterile injectable pharmaceutical products. From our world-class sites in North America and Asia, we deliver drug products with unparalleled quality to more than 100 markets around the world. Bora’s teams, technologies, and facilities work seamlessly together to enable our clients to deliver much-needed therapeutics to patients worldwide. At Bora Pharmaceuticals, we see it as our mission, our duty, our responsibility, to make our success and our customer’s success more certain. This is a permanent fulltime position. This job posting reflects a current vacancy within the organization. The position is active, approved, and intended to be filled as part of our staffing needs. This posting is for an existing and currently open position. The Maintenance Mechanic is responsible for preventative, predictive and routine maintenance tasks and commitment to continuous improvement of all machines and processes. The maintenance mechanic must be able to perform the tasks as a 433A certified millwright and be able to work on all the manufacturing and packaging equipment and collaborate with various stakeholders in the operations in solving equipment problems.

Requirements

5+ years experience with production processes and related equipment.
Troubleshooting and repairing mechanical equipment in a pharmaceutical or similar industry.
Good Understanding of GMP's, Safety and SOP's.
Proven technical competency in equipment design, optimization, and maintenance and reliability.
Strong equipment problem-solving skills.
Self-managed team player, adept at working with teams in a production environment.
Good leadership people and interpersonal skills.
Good communication skills, (oral & written - e.g., documentation).
Strong computer skills (Word, Excel, experience with computerized maintenance management-preferably SAP).
Ability to use and understand automation solutions such as IP21, eBRS, CDISY, Free Weigh, etc.
Grade 12 high school diploma or technical school experience.
Certificate of Qualification as Industrial Mechanic Millwright 433A.

Responsibilities

Provide support to production and quality by ensuring reliable operation of machinery & mechanical equipment.
Ensures maximum equipment efficiency, effectiveness and reliability by providing immediate corrective maintenance support to production line, troubleshoot issues, & repair failures of production equipment.
Perform mechanical duties of Tier 1 Millwright but with the more advanced troubleshooting skills on mechanical production equipment.
Provide expert mechanical support to manufacturing and packaging operations.
Work as part of a team to support the life-cycle design, installation, qualification, validation, troubleshooting, and optimization of packaging and manufacturing equipment.
Diagnose and repair malfunctioning production equipment.
Provide expert support for production equipment changeover and set-up.
Ensure compliance through timely and accurate completion of preventive maintenance work-orders and supporting documentation.
Train operators on changeover and set-up procedures.
Create and revise maintenance standard operating procedures and equipment knowledge assessment forms.
Maintain awareness and expertise in production equipment design, optimization, and maintenance.
Identify efficiency gaps in equipment functionality and provide solutions to support their continuous improvement initiatives.
Have an Advanced troubleshooting skills to the point of being able to independently solve mechanical problems that may also involve contacting OEM support and coordinating multi-disciplinary resources to achieve a resolution in a timely manner.
Ability to analyze why certain components break or fail or wear-out prematurely and to suggest or design improved components to prevent recurrence.
Have an advanced knowledge of material strengths and hardness’s, fits and finishes, tolerancing etc.
Have an advanced understanding of lubricants and lubricants used in various applications on GxP equipment. and cooling systems.
Must be able to read and interpret equipment mechanical drawings including pneumatics and hydraulics.
Must have working knowledge of pneumatics, electro-pneumatics and hydraulics and be capable in solving corresponding problems of these systems.
Must have machine shop skills including the ability to fabricate fairly complex replacement parts as required using plastic and metal stock.
Must be able to weld using MIG, TIG welding sets including oxyacetylene.
Must be able to troubleshoot equipment that have a more advanced understanding (and be able to troubleshoot) the more complex electrical control systems and devices used in modern production equipment and determine the cause and solution.
Be able to support reliable maintenance by determining minimum and maximum level of inventory parts as well as being able to find and source equivalent component parts for those that are obsolete obsolete or no longer easily available.
Having gained extensive detailed experience and knowledge on multiple systems and equipment throughout the plant in the various production units (and not just in their immediate designated production area).
Ability to support equipment projects related to IQOQPQ.
Determine root cause of complex equipment problems and implement relevant CAPAs.
Source and order spare replacement parts from OEMs and other sources.
Conduct work in a safe manner according to the Occupational Health and Safety Act and Company Policies.
Perform work in accordance with Company GMP rules and Standard Operating Procedures.
Training and guide new millwrights tier 1 in performing their tasks as required.
Any other duties that maybe assigned.