Manager, Engineering - CDMO

About the Role

The Manager, Engineering is responsible for the equipment and system performance of a cGMP manufacturing facility. This role leads, manages, and coaches engineering staff to ensure equipment and systems are designed, installed, and consistently perform as intended. The Manager develops an engaged, high-performing team that demonstrates Alcami core values with a culture of safety and quality. The role assists with developing strategies, processes, systems, procedures, and metrics to achieve high equipment availability, reliability, and performance. The Manager monitors equipment work orders, change controls, qualification status, and readiness, and manages engineering processes associated with new product introductions. This position oversees engineering support for multiple systems, processes, or areas, develops subject matter experts, and applies advanced approaches to implement improvements. The Manager directs, reviews, and approves engineering documents and supports monthly reports covering overall status, key issues, and performance KPIs. Responsible for directing, developing, and implementing controls and systems for Site Engineering and CAPEX project functions.

Schedule

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.
• Directs 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 objectives.
• Complies with the general policy of the company.
• Promotes a safe environment for work.
• Represents the Engineering activities during client audits and regulatory inspections.
• Ensures engineering procedures and systems are in a state of compliance and control.
• Establishes and maintains a system of metrics and reporting to evaluate the effectiveness of engineering activities.
• Responsible for employment, employee motivation, counseling, discipline, and changes in status of employees supervised.
• Responsible for team building, organizational development, and 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 current and evolving needs of the business through effective selection, training, coaching, mentoring, and performance management.
• Participates in the hiring process of other employees and makes hiring decisions.
• 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.

Requirements

• Requires a related Bachelor’s degree with 6+ years of relevant experience.
• Must have at least 2+ years of experience in management roles or relevant experience.

Skills

• 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.
• Communicates 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% domestic 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 job duties, which may include but is not limited to safety eyewear, various types of respirators/breathing apparatus, lab coats, and gloves.