Maintenance Engineer I

Role Summary

Maintenance Engineer I will support the implementation and execution of maintenance activities for API production equipment and systems at the DAPI-US facility. The role aims to improve reliability and performance of API operations by applying a reliability-centered mindset to maximize plant productivity while preserving equipment longevity. Key duties include leading maintenance performance improvement projects, supporting manufacturing teams to ensure maintenance compliance, providing technical support to stakeholders, and coaching the maintenance team.

Responsibilities

• Write/review maintenance plans, specifications & SOPs
• Participate in equipment/system design reviews & support equipment installation, commissioning & qualifications
• Assist in maintaining quality & schedule within area of responsibility
• Establish & maintain positive working relationship with internal & external engineering & operations stakeholders
• Lead & provide technical support for investigation, troubleshooting & problem resolution of equipment & system operational issues
• Support development, implementation & improvement of equipment & systems maintenance plans during operation
• Continuous improvement: verify process equipment & satisfy design requirements/expectations
• Knowledge sharing with local & DK facilities
• Develop knowledge of risk assessment documents, such as requirements risk assessments (RRA's)
• Support the review & updating of engineering & specification documentation (process flow diagrams, P&IDs, user req specifications, etc.)
• Drive maintenance team adherence to PSM requirements & best practices
• Participate in the review & updating of process & system risk assessments
• Other accountabilities, as assigned

Qualifications

• Required: Bachelor's Degree in engineering (preferred degree in maintenance, mechanical, chemical, electrical, bio-process engineering), or equivalent industrial, military, or vocational training combined with experience
• Required: Minimum three (3) years of experience working directly in utilities or process equipment maintenance, or other directly related field
• Preferred: Demonstrated experience in plant operations & maintenance with knowledge in RCA, troubleshooting, problem resolution & continuous improvement
• Preferred: Experience in pharmaceutical manufacturing environment with cGMPs or other regulated industry a plus
• Preferred: Six Sigma Green Belt or Lean 2-star certification
• Preferred: Demonstrated experience in maintenance processes & mechanical systems
• Preferred: Knowledge in mechanical systems operations, RCA, RCM, PHA, PSM & process improvement methodologies (Six Sigma, Lean)
• Preferred: Utility systems maintenance knowledge (cooling, chilled water, plant steam, compressed air, clean steam, purified water)
• Preferred: Knowledge of equipment maintenance for pumps, heat exchangers, control valves, mixers, agitators & filtration
• Preferred: API systems maintenance knowledge (centrifugation, spray drying, chromatography)
• Preferred: Experience with SAP, CMMS or similar systems
• Preferred: Ability to read equipment schematics, P&IDs, PFDs, wiring diagrams, CAD drawings
• Preferred: Understanding of URS, SAT, FAT, qualification & validation protocols
• Preferred: Experience with PLC, PCS, BMS & DCS control interfaces
• Preferred: Ability to apply engineering techniques & analysis independently
• Preferred: Strong project management skills
• Preferred: Excellent oral & written communication skills
• Preferred: Proven expertise in developing/planning/coordinating maintenance activities

Skills

• Project management and cross-functional coordination
• Root cause analysis and problem-solving
• Technical writing and documentation
• Effective communication with stakeholders at multiple levels
• Ability to read and interpret engineering diagrams and specifications

Education

• Bachelor's Degree in engineering (preferred in maintenance, mechanical, chemical, electrical, bio-process engineering) or equivalent training with applicable experience

Additional Requirements

• Physical requirements: ability to move equipment/supplies up to 33 pounds; stand for extended periods; may require climbing, working at heights, around hazardous materials, and in cold or loud environments; may involve confined spaces; driving exam for powered industrial trucks; no required valid driver's license