Maintenance Engineer - Amiseq : Job Details

Core Essential Skills sets candidates must have:

• 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
• Familiar with FDA requirements and cGMP guidelines
• Proficient in MS Office
• Proficient in Industrial Controls application software (Siemens PXCM, VPAK, Siemens Desigo)
• Attention to detail is essential with the ability to manage multiple projects concurrently in a fast-paced manufacturing environment.
• Ability to apply Engineering principles in practical application 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.

Maintenance Engineer II position acts as a mid-level position in Engineering processes and design for the Women's Health products. The qualified candidate shall have fundamental knowledge and experience in process / facility / equipment for the cGMP manufacture, particularly in pharmaceutical and medical device industries. Individual will work closely with and/or lead cross-functional teams including R&D, MS&T, Operations, Quality, and EHS to implement capital projects. Individual will be the host for vendors while onsite and ensure all appropriate guidelines are followed. Able to work independently with minimal guidance in complex situations.

Key Responsibilities:

Lead/ perform work within Facility projects (BMS/BAS Controller Upgrades, site utilities upgrade/replacement projects)

Assist in monitor 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 system.

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.

Ability to work closely with several disciplines within the company such as manufacturing and production personnel, engineering, management, and finance.

Qualifications

• 3-5 years of experience in engineering field, prefer in pharmaceutical or medical device industries