Maintenance Engineer II
7 days ago
The Maintenance Engineer II position is a mid-level role in engineering processes and design for Women's Health products. The candidate should have fundamental knowledge and experience in process/facility/equipment for cGMP manufacturing, particularly in the pharmaceutical and medical device industries. The individual will collaborate with and/or lead cross-functional teams including R&D, MS&T, Operations, Quality, and EHS to implement capital projects. The candidate will host vendors onsite and ensure all appropriate guidelines are followed, working independently with minimal guidance in complex situations.
Core Essential Skills
• Experience in facility and equipment design process or procurement
• Experience in execution and involvement within facility capital projects
• Experience in Installation Qualification/Operational Qualification protocol drafting and execution; periodic reviews experience a plus
• Familiarity with FDA requirements and cGMP guidelines
• Proficient in MS Office
• Proficient in Industrial Controls application software (Client PXCM, VPAK, Client)
• Attention to detail with the ability to manage multiple projects concurrently in a fast-paced manufacturing environment
• Ability to apply engineering principles in practical applications with strong analytical skills
• Strong written communication skills to effectively communicate through all levels of the organization
• Bachelor of Science in Engineering (Chemical, Mechanical, or Electrical preferred)
Key Responsibilities
• Lead and perform work within facility projects (BMS/BAS Controller upgrades, site utilities upgrade/replacement projects)
• Assist in monitoring plant facility processes and systems to achieve manufacturing excellence, utility optimization, and maximize equipment availability
• Maintain ownership and accountability for plant piping and instrument diagrams, including steam, compressed air, nitrogen, and purified water systems
• Evaluate processes and perform risk assessments to identify cost reduction and/or equipment availability improvements
• Document current maintenance processes and assist with tribal knowledge transfer
• Collaborate closely with several disciplines within the company, including manufacturing and production personnel, engineering, management, and finance
Qualifications
• 3-5 years of experience in the engineering field, preferably in pharmaceutical or medical device industries
Education: Bachelors Degree
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