Our client, a leading global biopharmaceutical company, is looking for a SME in OSD equipment and technologies to lead their site as they invest in building of a pilot plant focused on clinical OSD manufacturing.
The Lead Maintenance Engineer will not only oversee this build out but also will be the SME onsite for all OSD equipment. This will include leading troubleshooting and preventative maintenance. In this role, you will assist with troubleshooting, identification, and implementation of process/equipment improvements (utilizing Change Control systems) to reduce waste and increase process reliability.

BASIC QUALIFICATIONS:

• 5+ years of Oral Solid Dose equipment experience, such as Tablet Press, Coating, Blender, and Mill (mandatory).
• 10+ years of pharmaceutical experience
• Seven to fifteen years of maintenance experience.
• Two-year technical degree or trade school (BS degree preferred).

KNOWLEDGE/SKILLS NEEDED:

• Superior mechanical aptitude
• Good pipe fitting, plumbing, and industrial maintenance skills
• Good knowledge of rotating machinery (pumps, fans, blowers)
• Thorough mechanical / electrical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
• Knowledge of automated control systems.
• Knowledge of computer systems operation and software.
• Thorough knowledge of cGMP, OSHA, EPA, and FDA facility requirements and regulations.
• Knowledge of chemistry, statistics, equipment design, process control, and process scale-up.
• “Hands-on” ability to install and troubleshoot instrumentation and equipment.
• Ability to troubleshoot and maintain manufacturing systems, equipment, and processes.
• Ability to author high-quality technical protocols/reports (Engineering Studies, commissioning protocols, summary reports, equipment specifications, SOPs, deviation investigations).
• Ability to specify and size manufacturing systems, equipment, and process equipment.
• Familiarity with OSD companies such Korsch, Glatt, Freund Vector, Syntegon, Netzsch and Gerteis.

• Perform PM’s
• Follow written preventative maintenance procedures
• Accurately complete maintenance paperwork, including work orders and logbooks.
• Supervise and review the work performed by others.
• Review and update maintenance procedures based on field experience.
• Review and update drawings to reflect as built conditions.
• Identify opportunities for improving PM program.
• Recommend changes to PM program based on experience with equipment and analysis of historical data.
• Accept ownership of selected equipment and serve as point person for repairs/PM.
• Train fellow mechanics on technical details.
• Identify critical spare parts based on field experience.
• Execute repairs
• Respond to customer requests and/or alarm conditions.
• Assess breakdowns, systematically identify problems, and restore to operation.
• Accurately document repair activities.
• Support Quality Assurance investigations of breakdowns.
• Contractor Support
• Supervise contractors performing tasks within building.
• Ensure that contractor employees follow Alkermes safety and cGMP standards.
• Oversee technical quality of work performed.
• Lead Small Projects
• Identify facility/utility improvement projects, develop scope and estimates, and manage small (
• On-Call and Emergency Response. Respond to a variety of problems that may and do occur. Locate, determine, and correct problems or contact appropriate personnel for assistance. On-Call duties responding to emergencies 24 Hours/Day. On-Call rotation is usually one week out of every six.