Director, Maintenance and Engineering

Calea LTD.

$142K — $199K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5-10 years experience in engineering and maintenance management in a regulated environment
  • Strong background in cGMP compliance and facility operations
  • Proven project management skills, especially in design and construction of manufacturing facilities
  • Knowledge of validation protocols for critical equipment and processes
  • Familiarity with ISO standards including 14001, 50001, and 45001

Responsibilities

  • Direct Engineering and Maintenance functions to ensure facility compliance
  • Lead design and construction projects for manufacturing plants and systems
  • Manage the startup of new processes and technologies to improve efficiency
  • Oversee the preparation and approval of validation protocols
  • Review documentation for major systems at the plant
  • Develop and lead staff through effective management and training practices
  • Ensure adherence to cGMP, OSHA, and DEC regulations in operations

Benefits

  • Comprehensive health benefits including medical, dental, and vision coverage
  • 401(k) plan with company contributions
  • Paid vacation, holiday, and personal days
  • Employee assistance program
  • Participation in a medium-term incentive plan and bonus opportunities
Full Job Description

Job Summary

Leads the Site Engineering and Maintenance teams. Responsible for ensuring that the facility and equipment are kept up-to-date and in good working order. Responsible for strategic, capital and facility planning. Responsible for ensuring the facility and equipment are in compliance with cGMPs.

Salary Range: $142,929- $199,910

Position is eligible to participate in a bonus plan with a target of 16% of the base salary.

Position is eligible to participate in our medium-term incentive plan.

Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. Read more about our benefits here.

Responsibilities

PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

  • Direct Engineering and Maintenance functions.
  • Lead projects such as the design of manufacturing plants, manufacturing lines and utility systems.
  • Lead the startup of new processes and technologies.
  • Manage the preparation and approval of validation protocols for critical equipment and/or processes.
  • Review final documentation packages for all major systems at the plant including, but not limited to Utility systems, filling operations, packaging operations, dry heat sterilization/depyrogenation, steam sterilizers and process washers.
  • Lead the design and construction of new and renovated facilities.
  • Manage company capital and expense budgets.
  • Develop, organize and lead staff.
  • Lead projects to continuously improve processes.
  • Maintain cGMP, OSHA, and DEC compliance through implementation and adherence to SOP’s and governmental regulations.
  • Directly responsible for maintaining facility and systems compliance and operation.
  • Directly assures compliance to project schedules to meet production requirements and launch of new products

Additionally:

  • Ensures department personnel are aware of the Environmental Management and Energy Management Systems and promotes continual improvement taking accountability for the effectiveness of the Environmental Management and Energy Management Systems according to ISO 14001 and ISO 50001 standards.
  • Responsible for ensuring that Health, Safety and Environmental requirements are met under ISO 14001 standards.
  • Responsible for ensuring that Energy Management Requirements are met under ISO 50001 standards.
  • Responsible for ensuring compliance to Occupational Health and Safety is met under ISO 45001.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

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