Associate Director, Engineering - CDMO

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 Associate Director, Engineering is responsible for the equipment and system performance of a cGMP manufacturing facility. The Associate Director leads, manages, and coaches engineering staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. The Associate Director develops an engaged, high performing team that demonstrates Alcami core values with a culture of safety and quality.

The Associate Director of Engineering assists with developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. The Associate Director monitors equipment work orders, change controls, qualification status, and readiness. Manages engineering processes associated with new product introductions. The Associate Director is responsible for developing and implementing strategies, methods, and procedures for new and existing equipment.

The Associate Director, Engineering oversees engineering support for multiple systems, processes, or areas. Develops subject matter experts in several areas. Applies advanced approaches to develop and implement strategies, technologies, or other major improvements. Directs, reviews, and approves engineering documents. Support monthly reports covering overall status, key issues, and performance KPI’s. Responsible for directing, developing, and implementing the necessary controls and systems for the Site Engineering, and CAPEX project functions.

This role drives results and is responsible for successfully meeting client and departmental objectives in a timely manner. This position requires strong leadership behaviors, as well as expertise in the functional competencies included in this position.

On-Site Expectations

• 100% on-site position.
• 1st Shift: Monday - Friday, 8:00am - 5:00pm.

Responsibilities

• Provides leadership and direction to the Engineering team.
• Directs engineering and capital project activities for the site.
• Direct implementation of improvements to reduce failures and errors.
• Oversees multiple capital projects and operational improvement projects, DEVs, CAPAs, and/or Change Controls while ensuring their success in meeting their respective objectives.
• Comply with the general policy of the company.
• Promote a safe environment for work.
• Represent the Engineering activities during client audits and regulatory inspections.
• Ensures engineering procedures and systems are in a state of compliance and control.
• Establish and maintain a system of metrics and reporting to evaluate the effectiveness of engineering activities.
• Responsible for the employment, employee motivation, counseling, discipline, and changes in status of employees supervised. Responsible for team building, organizational development, training.
• Assists in development, strategy, planning, and execution related to drive improvements and achievement of objectives and goals.
• Maintains and broadcasts key metrics to management.
• 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.
• Participates in the hiring process of other employees.
• Makes hiring decisions of other employees.
• Accountable for the curriculum assigned and timely completion of training of employees to meet regulatory requirements.
• Schedules and reviews the work of other employees.
• Prepares and delivers performance evaluations of other employees.
• Coaches, mentors, and develops other employees.
• Makes recommendations of disciplinary actions of other employees.
• Other duties as assigned.

Qualifications

• Requires a related Bachelor’s degree with 10+years of relevant experience.
• Must have at least 4+ years of experience in management roles or relevant experience.

Knowledge, Skills, and Abilities

• Strong technical skills for area managing.
• Good business acumen.
• Strong understanding of company SOPs, and regulatory guidance documents.
• Strong knowledge of safety procedures and quality compliance for assigned area.
• Strong attention to detail, as well as time and resource management.
• Good presentation skills
• Strong personnel and professional integrity and trustworthiness with strong work ethics and the ability to work independently with some direction.
• Communicate well orally both for internal customers and team members as well as external customers.
• Ability to write reports and business correspondences.
• Ability to listen and respond well to external customers, partners, and colleagues at all levels.
• Highly goal and result oriented.
• Knows how to obtain support from different collaborations.
• Tackles problems with enthusiasm and curiosity.
• Treats colleagues at all levels with respect.

Travel Expectations

• Up to 10% travel required.

Physical Demands and Work Environment

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee may be required to use hands to finger, handle, or feel and to reach with hands and arms. The employee is required to talk and hear. The employee is frequently required to stand, walk and sit. The employee may be occasionally required to climb or balance. The employee may be required to regularly lift and/or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, and peripheral vision.

While performing the duties of this job, the employee may be occasionally exposed to moving mechanical parts, high precarious places and vibration. The noise level in the work environment is usually quiet. The employee may be required to gain access to lab, manufacturing or clinical areas for inspections or work discussions. The employee is required to wear the appropriate personal protective equipment to perform the job duties. Such personal protective equipment may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, gloves, etc.