Sr. Director, Engineering

 

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

 

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Job Summary

The Director, Engineering, Validation, and Maintenance drives results in a fast-paced environment by developing and executing engineering, validation, and maintenance strategies supporting on-going and future facility, utility, manufacturing, and laboratory systems throughout the life cycle of an asset. Engineering includes but is not limited to project scope, cost estimates, schedules, design, procurement, installation/construction, and plant engineering. Validation includes factory acceptance tests, commissioning, installation qualification, operational qualification, performance qualification, and re-qualification program. Maintenance includes but is not limited to preventative maintenance, work order repairs, and facilities programs including security, housekeeping, landscaping, and pest control. In addition, the Director, Engineering, Validation, and Maintenance supports the strategic development of the organizational capabilities of the department.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:30am - 4:30pm.

Responsibilities

• Develops, implements, and maintains robust engineering, validation, metrology, and maintenance standards. Ensures changes are consistent with other sites in the network.
• Manages internal engineering, validation, and maintenance processes as well as provides support to other groups. Including but not limited to:
  • Capital Program: Quarterly forecast, annual capital budget, long term capital plan, individual capital packages. Responsible for controlling the site’s capital budget and adhering to project schedules.
  • Pest Control: Bi-weekly third-party treatment/inspections, review/approval of third-party results, annual program assessment, and audit support.
  • Insurance Program Ownership: Property and equipment breakdown surveys/audits. This includes back-up generators, roof inspections, and fire protection amongst other like topics.
  • Drawing Program: Review and approval of GMP critical, security drawings in EDMS and maintaining building and construction drawings.
  • Security Program: Includes badge readers, camera systems, intrusion systems, and oversight of security guards.
  • Contractor Management: Includes but not limited to training and escorting when applicable.
  • Facility and Utility Ownership: Must understand function, layout, and capacity of key site systems. Will be SME during client and regulatory audits on these topics.
  • ESG: Will lead certain aspects of the site’s ESG program including understanding the amount of energy utilized at the sites and initiatives to reduce that usage. The team will be responsible for tracking what type of refrigerant is used in the site’s systems.
  • Maintenance: Will own the site’s preventative maintenance and work order programs (both GMP and non-GMP work orders).
  • Business Continuity: Will help spearhead the site’s Business Continuity Plans including water damage mitigation plans and key redundancies.
• Oversees the equipment, facilities, and utilities qualification program, and drives innovation to remain current.
• Leads the site’s metrology group (calibrations and repairs).
• Leads the design, implementation, monitoring, and control and closure stages of major department and capital projects for the facility.
• Leads and actively participates in client interface in regards to equipment, facility, and utility lifecycle.
• Oversees and develops the facility long-term capital investment plan and departmental operating budget.
• Cultivates an efficient, professional, and safe working atmosphere and ensures timely results are achieved.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring, and performance management.
• Represents the department in meetings, collaborates and cooperates to achieve cross-functional improvements and business goals.
• Creates departmental systems and fosters a culture of continuous improvement focused on value to the customer.
• Manages the day-to-day operations for assigned area.
• Participates in and supports client visits, audits, and inquiries to ensure complete fulfillment of requests and interests.
• Provides technical guidance for troubleshooting and investigating sim