Chad Michalski

Provide technical support for troubleshooting, improving, or optimizing ongoing facilities and manufacturing operations Work with vendors, suppliers, and contractors to effectively execute required maintenance, calibration and qualification activities KEY RESPONSIBILITIES: Specific Responsibilities include: Execute corrective and preventive maintenance related to specific oral solid dosage manufacturing equipment and qualified utilities including work methods, procedures and documentation within a validated CMMS system Oversee and escort non-resident contractors and suppliers to execute corrective and preventive maintenance Investigate opportunities for improvement and implement best practices Review/ approve vendor documentation to ensure that accurate, concise documentation is submitted and meets all the requirements of GMP's and internal SOP's Other duties as directed by the GxP Facility Operations Maintenance Manager POSITION QUALIFICATIONS: Demonstrated hands-on experience with mechanical, plumbing, pneumatic, hydraulic, and electrical equipment and tools Demonstrated ability to operate independently and without direct supervision and seamlessly integrate into a team atmosphere Pro-active self-learner with strong troubleshooting and repair skills 3-5 years' experience working in a regulated industry such as pharmaceutical, nuclear, ISO, or military Experience with operating EMS, BMS & CMMS systems Physical abilities include but not limited to, lifting objects up to 50lbs, able to be on feet all day, climb steps and ladders as required by job Excellent verbal and written communication skills Strong interpersonal skills including the demonstrated ability to manage through influence Ability to navigate and be successful in a fast-paced, highly matrixed work environment Present an energetic, positive, solution-oriented attitude

• Responsible for planned maintenance, proper operation, and unexpected repairs on all equipment and clean utilities including WFI system, Clean Steam, RODI, Lyophilizers, Clean Compressed Air system and other equipment within multiple freeze drying manufacturing sites.
• Responsible for other equipment including (4) natural gas boilers, GMP and non-GMP area HVAC, autoclaves, parts washer, depyrogen oven, internal and external vial washers, and other equipment within clean room of Fill-Finish facility.
• ISO 5 Gown qualified and Media Fill qualified.
• Responsible for scheduled maintenance on daily, monthly, annually, biennially and further basis.
• Responsible for purchasing and inventorying spare critical parts for equipment to reduce or limit potential downtime due to equipment issues.
• GMP & GDP trained and qualified to FDA and other foreign agency standards.

• Responsible for repairs and replacement of insulation on all piping and equipment throughout various buildings.
• Responsible for large scale insulation repairs on multi floor vessels and other critical equipment and clean utilities.
• Work with and around operations to avoid potential down time and delays to production.
• Insulation performed on select piping to avoid potential safety concerns and risks,
• Responsible to evaluate large and small projects to ensure proper materials are ordered.
• Work within various clean rooms and mechanical spaces following guidelines and rules to be GMP compliant.
• GMP and GDP trained to FDA and company standards.
• Work on other general maintenance activities including paint/patch work, door repairs, any other miscellaneous maintenance repair work.

• Piping insulation on various piping including chilled water, steam, and other commercial and residential piping.
• Insulation on various ductwork and HVAC units.
• Work alongside installers and other contractors to ensure work completed on time to does not hold up project at hand.
• Complete training to work within various government and medical facilities that require certain clearance or credentials.

• Disassembly and reassembly of various body panels and components of a variety of makes of vehicles.
• Body work from initial repairs to final prep of vehicles ready for paint.
• Replacement of damaged body panels on vehicles.
• Reassembled and replaced parts to complete body repairs.
• Inspected vehicles to identify and document repair needs.
• Followed standard operating procedures to achieve consistent quality of work.
• Applied finishing techniques to enhance quality and appearance of repairs.