· Job facts
Main Purpose of the Position :
Under the direction of Finished Goods (Inspection or Packaging) Supervisor/Manager or other qualified Production Mechanics, perform a wide variety of tasks and operations that are required to inspect and package sterile pharmaceutical products in a state-of-the-art, automated inspection and packaging facility. Troubleshoot, maintain, assemble, install, and repair all electronic, mechanical, and instrumentation devices on production equipment as required. Assist on major equipment overhauls, repairs, and installations as necessary. All operations will be carried out in compliance with cGMPs, Standard Operating Procedures (SOPs), product recipes, and Genentech standards.
In addition to performing the responsibilities/tasks below, the successful candidate will need to demonstrate the following traits:
· Passion and drive to develop and maintain a LEAN culture dedicated to providing the best results for our internal and external customers.
· Continuously in search of ways to maintain the highest levels of productivity and equipment reliability.
· Actively participates in a teamwork environment that maintains a high performance culture.
· Bring a positive impact to the Manufacturing and Mechanical Services teams.
· Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
· Perform safety and housekeeping audits as required.
· Set up, change over, and test run equipment for various-sized vials and packages as required.
· Make mechanical and electrical adjustments necessary for the correct operation of the equipment.
· Act as a troubleshooter, moving between all areas to assist related crafts in the performance of their duties. Diagnose problems involving mechanical, electronic, electrical, instrumentation, and pneumatic hydraulic control systems. Work with the engineering/automation teams, maintenance department and/or outside services to repair, maintain, and calibrate these systems as required.
· Perform or coordinate major and minor Preventative Maintenance/overhauls of production equipment as needed.
· Perform training of other Operations Mechanics and Manufacturing operators.
· Assist in the development of plant SOP's and training materials.
· Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (SAP and MES systems).
· Assist and/or operate all inspection and final vial packaging equipment in the plant. Perform material handling in the plant as required.
· Perform preparation of sterile components and inspection of vials as needed.
· Assist in the cleaning, set-up, sterilization, and performance of maintenance on a variety of processing equipment.
· Prior to start-up, during processing, and at the completion of the manufacturing process, perform all documentation and clerical functions to provide the proper accountability and traceability of components and finished product.
· At the start and finish of each shift, report and make recommendations regarding equipment, supplies, required repairs, process concerns, safety concerns, and areas for improvement in reliability, yield, and efficiency.
· Initiate, own and execute change records to improve equipment/process performance as needed.
· Update procedures as needed to maintain clear instructions and document tribal knowledge to close knowledge gaps.
· Work effectively and efficiently in a team-oriented environment to ensure maximum and high quality output.
· Perform cleaning and housekeeping duties as required.
Qualifications / Requirements:
Proficiency in the English language - reading, writing, and communication. Must be able to work all shifts (Day or Swing) Monday - Thursday, required overtime as needed, able to lift 45 pounds, and stand for extended period of time. In addition, all candidates must pass a vision acuity and color discrimination test.
· High school diploma or equivalent.
· Graduate of a two-year Associates Degree program in Electrical/Mechanical Technology (or equivalent) is desirable.
· Higher level degrees or equivalent training experience are highly desirable.
Three years recent (within the last 5 years) experience in the set-up, repair and operation of complex mechanical equipment used in the washing, filling, conveying, sealing, inspection and packaging of products/containers. This experience must include equipment set-up, changeover, mechanical/electrical repairs, disassembly, and preventative maintenance. Target industries include pharmaceutical, biotechnology, biomedical, electronic, and chemical, food, cosmetics, and/or other regulated industries.
Special Skills or Abilities:
Ability to read Piping and Instrument Diagrams, electrical drawings, blueprints, PLC ladder logic, etc. Ability to analyze instrumentation and electronic maintenance problems and take appropriate corrective measures. Knowledge of mechanical, electrical, hydraulic, and pneumatic principles.
Must be computer literate, including ability to interface with computer systems and PLC-based logic. Must be comfortable working with Microsoft suite (Word, Excel, PowerPoint), navigating through web pages and e-mail. Must possess basic typing skills.
Job descriptions are not intended, and should not be construed, to be all-inclusive lists of all responsibilities, skills, efforts, or working conditions associated with a job. While this description is intended to be an accurate reflection of the job requirements, management reserves the right to modify, add, or remove duties and to assign other duties as necessary.
Roche is an equal opportunity employer.
Manufacturing, Manufacturing > Manufacturing Facilities & Engineering
· Who we are
A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work.
Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.