Manufacturing Engineer I

Company Description

Laclede Inc. is a leading contract manufacturer of private label and custom formulations, based in Southern California. For more than 25 years, Laclede has produced products for clients ranging from Fortune 500 CPG corporations and up-and-coming entrepreneurs to the leading retailers all over the globe. Laclede provides total turnkey service for both the human and pet markets. Our research has produced the global leaders in teeth whitening gel and dry mouth products, among other premier offerings.
Role Description

We are seeking a Manufacturing Engineer / Maintenance Technician to be responsible for overseeing the routine and preventative maintenance for all facility equipment in an FDA regulated manufacturing environment and following FDA & GMP compliance record keeping.
As the Manufacturing Engineer, you will work closely with the production managers, utilizing effective communication to ensure that the facility and equipment is running to required FDA, cGMP and/or OSHA compliance.
This Manufacturing Engineerwill lead a team of 3 maintenance professions and administer training of new hires, oversees the design, installation, and qualification of new equipment. The Manufacturing Engineer will oversee all general facility services, performs advanced tasks and completes the most-difficult assignments. 
Primary Duties and Responsibilities:

• Troubleshoot, rebuild, overhaul, repair, maintain, modify and install various types of electrical and production equipment, tools and machinery as required.
• Performs root cause analysis of facility equipment, facility support utilities and manufacturing equipment failure.
• Assists QC Department with reporting for facility compliance.
• Evaluate quality control processes and make recommendations for improvements
• Analyze production equipment/machines/methods and other data and then provide management with reports containing the data and statistics to enable management to better understand future requirements needed for the manufacturing process
• Requires understanding of building mechanical and electrical systems, as-builts, schematics and flow diagrams.
• Maintains a safe work environment; work in a safe manner following all safety SOP’s and wear Personal Protective Equipment as required.
• Maintains accurate record keeping of equipment and systems for regulatory compliance, such as FDA, OHSA, CAL-OHSA, GMP or customer required compliance including calibration records.
• Works independently and make sound judgments regarding work methods and tools. Proactively support the Company’s goals and objectives.
• Coordinates and escort outside vendor services and monitor to ensure work is completed according to specifications.
• Coordinate equipment/machine maintenance and repair services and ensure manufacturers and instructions are followed in order to keep production equipment operational.
• Ensures FDA/GMP manufacturing labs and lab personnel are supported to meet business needs including lab gasses, preventive maintenance, equipment service contracts and safety equipment.
• Assists in the design, installation, and qualification of new facility equipment and systems within scope of expertise. As well as monitors, maintains, and responds need of facility equipment.
• Performs routine maintenance tasks including maintenance of all manufacturing equipment, plumbing repairs, office furniture installation, and general building repairs, and other as assigned.
• Ensure clean rooms and general facility is maintained in optimum conditions and in compliance with GMP requirements.

• BS degree in Mechanical, Electrical, Manufacturing Engineering or a Science related field
•  5+ years of experience in engineering within a pharmaceutical manufacturing operation.
• Specific knowledge of cGMP, pharmaceutical manufacturing methods and engineering principles.
• Understanding of engineering fundamentals
• Technical knowledge of processes/equipment/utilities (e.g. batches processing, tank, filtration, purified water system, HVAC, etc.)
• Equipment Qualification and Validation IQ/OQ/PQ, SOPs
• AutoCAD design software experience
• Excellent written and oral communication skills combined with the ability to write technical documents and reports.
• Experience in communicating in an FDA regulated environment.
• Ability to communicate in a proactive and solutions-focused manner, including keeping management aware of potential issues.
• Basic computer knowledge, including Microsoft Word, Excel and Office 365.
• Time management, team management, strong analytical math and problem-solving skills. High level of safety awareness. And the ability to communicate effectively and ability to function well in a team environment are all vital.
• Proficient in reading schematics and diagrams as well as other written materials

Compensation

• Starting base salary of $70,000 (depending on experience) with a bonus plan
• Paid time off (vacation/sick/holiday)
• Medical
• Dental
• Vision
• 401K

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