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Sr. Manager Manufacturing Engineering jobs in United States
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Endo · 15 hours ago

Sr. Manager Manufacturing Engineering

Par Health is a leading healthcare organization committed to improving lives through quality and safety. The Sr. Manager of Manufacturing Engineering will provide strategic leadership and oversight for manufacturing processes, ensuring compliance and optimization within a pharmaceutical manufacturing environment.
Pharmaceuticals
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Comp. & Benefits

Responsibilities

Year-Over-Year Improvement In Functional Organizational Structure & Capabilities
Talent Portfolio that Ensures Achievement of Organizational Objectives: Analyzes the skills and capabilities of the functional area; identifies future workforce requirements; and identifies means to close any gaps. Ensures processes are in place for unleashing the full potential of others by providing needed resources, coaching, experiences and other support to place the right people in key roles and continuously upgrade their skills and knowledge
Critical Talent Retained: Effectively identifies the positions and people that have the greatest impact on organizational effectiveness. Understands the goals and needs of critical talent and ensures that initiatives are in place to foster retention
Organizational Structure that is “fit for purpose”: Develops an organizational structure that ensures the day-to-day delivery of objectives; supports the retention and development of staff to deliver a high level of services; as well as provides succession and development opportunities for high-potential employees
Functional Area Budgets that Make Appropriate Trade-offs: Facilitates the budgeting process to ensure organizational resources are allocated effectively to the areas of the business that have the greatest impact
Critical Business Decisions: Demonstrates knowledge in how the business works; understands the competition and the organization’s changing priorities; integrates financial data effectively allowing for the resolution of key issues; contributes to appropriate financial strategies and systems to maximize cash flow and limit risk to the organization; directs development of realistic project completion schedules while ensuring site efficiency, safety and quality are maintained
Employees Aligned to Vision, Direction and Goals: Aligns priorities with the direction and priorities of the broader organization. Diagnoses whether assigned functional areas are performing at full potential and ensures communication cascades down through the organization. Breaks down organizational silos, bridges communication gaps, and engages the employees they manage so the entire workforce can understand how the company operates and how each person can contribute to the company’s success. Collaboratively develop team metrics, modeling and reinforcing mindsets and behaviors necessary to drive results. Engage people in driving plant goals using shop floor metrics, visual factory, etc. Understand/communicate financial and day-to-day goals to employees in a way that can be easily understood. Sets vision and direction for the Engineering function, including creating and implementing a solid set of goals to drive business results
Champion Change & Innovation: Ensures an environment that encourages fresh perspectives, innovative, breakthrough ideas and new paradigms that create value in the marketplace. Initiates, sponsors, and implements organizational change. Develops/implements new processes and drives current processes to continually improve business results. Role Model for Core Values: Through words and actions, embodies the company values in his/her day-to-day actions. Defends and upholds the values by ensuring employees understand the behaviors and actions that support them
Facilities And Production-Related Equipment Optimized To Meet Company Objectives: Collaborate with teams on day-to-day equipment readiness and performance. Monitors equipment change controls, qualification status and readiness. Procures all facilities and equipment, at the Hobart site, required to support the business plan. This includes maintenance of all existing buildings and equipment and, when required, constructing new facilities or purchasing additional equipment. This position is also responsible for any alteration or renovation of facilities. Ensures that all facilities, equipment, and systems are in full compliance with all applicable laws and regulations including Federal, State, local, and International. Including all regulations relative to the production of drug products, handling and storage of controlled substances, environmental, and life safety. Develops and maintains energy utilization/reduction programs, procedures and processes that are environmentally sound. Directs design, layout and construction of equipment and facilities for the site in compliance with federal, state and local codes as well as meet the regulatory requirements representative of the pharmaceutical manufacturing industry. Through understanding of the use of re-engineering and engineering controls, improves safety, quality and cost. Organizes and implements continuous improvement techniques within area of responsibility (including Kaizen, Six Sigma, and Lean Manufacturing)
Site Capital Master Plan that Ensures Capacity to meet Mallinckrodt Strategy: Develops site master plan and long-range planning, as well as presentations for team and management. Continually monitors and evaluates the organization’s direction, understands changing priorities, its implications on the Site Capital Master Plan, and makes adjustments as required. Develops and shares capital and expense budgets. Monitors and controls on a continual basis the expenditures for each budget. Recommends capital and expense items for landlord capital and expense budgets. Develops and shares annual and long-range department budgets for both capital and expense spending
Capital Projects Achieve Required Return On Investment: Plans, develops, coordinates, and directs large engineering projects or several small projects with many complex features as required. Manages and works within or below the annual site Capital budget of $10-$15 million and department budgets of approximately $7 million
Leads and actively participates in new product scale-up, process optimization, technology transfer, design of experiments, as well as equipment qualification and process validation activities. Responsible for the delivery of all major capital projects on the Hobart site. Project execution includes; development of business cases and requests for funding, development of specifications and designs, development of project plans, bidding and award of bids, construction management, and commissioning and qualification. Directs modifications, renovations, or improvements to existing equipment, processes, utilities and facilities to reduce cost, improve efficiency and comply with cGMP requirements. Assesses the feasibility and soundness of proposed engineering evaluation tests, products, or equipment, when necessary, data are insufficient or confirmation by testing is advisable
Maintains positive and collaborative working relationships with internal and external customers
New Product Feasibility Recommendations: Interfaces with appropriate departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. Work closely with quality and product development to insure high quality transfer of products and technology, identify opportunities for improvements and support technical innovations. Researches novel assignments requiring the development of new or improved techniques and procedures. Work is expected to result in the development of new or refilled equipment, materials, processes, products, and/or scientific methods. Work collaboratively with other managers to ensure consistency and solid communication between departments. Main point of contact for engineering function

Qualification

Manufacturing EngineeringSix SigmaLean ManufacturingRegulatory ComplianceBudget ManagementProcess OptimizationEquipment QualificationTechnical InnovationProject ManagementCoachingAnalytical Problem SolvingLeadershipCommunication SkillsNegotiationTeam Collaboration

Required

BS in Mechanical, Chemical, Industrial or Electrical Engineering or related field
Minimum of Ten (10) years of applicable experience, encompassing API, dosage, biological, parenteral, and related manufacturing operations
High degree of Six Sigma and Lean manufacturing knowledge
Seven (7) years of proven leadership and management experience at senior site leadership team level
PE, CEM, Stationary Licensing as appropriate
Ability to leverage systems and manage multiple projects
Computer literate/proficient in Word, Excel and PowerPoint
Has in-depth knowledge of compliance with GMP, DEA, FDA, ICH and EPA
Provide ability to effectively manage change
Ability to interact with R&D, Engineering, Quality, Manufacturing, Regulatory, Finance, Marketing, Logistics, and other key internal customers; outside suppliers on quality, delivery and price
Excellent verbal and written communications skills

Preferred

Skilled in the areas of negotiation, sourcing strategy, development, risk analysis, analytical problem solving, capacity analysis, inventory management, and commercial agreements
Proven leadership and success in the development of others

Benefits

This position is eligible for a bonus in accordance with the terms of the applicable program.

Company

Endo combined with Mallinckrodt Pharmaceuticals in 2025 to better serve customers and improve outcomes for the patients we support.

Funding

Current Stage
Late Stage

Leadership Team

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Blaise Coleman
President and Chief Executive Officer
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Jennifer Lynn Fernandez
Sr. Executive Coordinator to President and CEO
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Company data provided by crunchbase