Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.
Job Description Summary
The Sr. Manager of Manufacturing Engineering provides strategic leadership and oversight for process and manufacturing engineering, utilities management, procurement, automation and controls related to facilities and maintenance, capital budgeting, and regulatory compliance within a complex pharmaceutical manufacturing environment. This function manages and directs large scale projects for the site, ensuring safety, functionality, efficiency and optimization of space and equipment using continuous improvement strategies and industry best practices. This role ensures that facilities and equipment are consistently up to date and able to support the organization's operational and business objectives. The Sr. Manager of Manufacturing Engineering is responsible for maintaining compliance with all applicable regulatory bodies, including the FDA (and international equivalents), DEA, OSHA, NFPA, DEC, and national, state, and local building codes. As a member of the site leadership team, the Sr. Manager collaborates closely with the Site Director and other senior leaders to develop and implement integrated strategies that address both immediate operational needs and long-term ambitions. The role also involves significant external engagement, including interactions with customers, support for business development initiatives, proposal evaluations, and participation in audits conducted by quality and regulatory authorities such as the FDA, OSHA, and EPA.
Job Description
Essential Functions
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.
Minimum Requirements
Education:
BS in Mechanical, Chemical, Industrial or Electrical Engineering or related field. MS in Engineering preferred.
Experience:
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.
Certifications/License:
PE, CEM, Stationary Licensing as appropriate
Preferred Skills/Qualifications:
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.
Other Skills/Competencies:
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
Organizational Relationship/Scope:
Building Organizational Talent: Anticipates talents, skills and knowledge that will be needed in the organization; seeks out opportunities to grow people's capabilities to match those needs; improves the results of others by identifying areas of performance strengths and development opportunities, by providing coaching, mentoring or development opportunities, and by providing clear, behaviorally specific feedback to team members and subordinates; creates a learning environment that ensures associates realize their highest potential, allowing the organization as a whole to meet future challenges. Develop direct reports, through coaching, mentoring, and professional development, instilling and encouraging a team and continuous improvement focus that exemplifies Par Health's Cultural Hallmarks. Leads mentors and coaches the team.
Negotiation (balancing budget against trade-offs): Identifies and proposes solutions that benefit all parties involved in a situation; seeks out and builds relationships with others who can provide information, intelligence, career support, potential business, and other forms of help; accurately anticipates the implications of events or decisions for various stakeholders in the organization and plans strategy accordingly; can negotiate skillfully in touchy situations with both internal and external groups.
Business case development: Uses financial analysis to evaluate and create strategic choices and options; knowledgeable about how the business and organization work; knowledgeable in current and possible future policies, practices, trends, and information affecting the business and organization; understands the competition; is aware of how tactics work in the marketplace; devises an approach that best positions an idea, plan or activity; leverages supportive factors, breaks through barriers, and addresses the unique needs and preferences of key decision makers.
Driving Execution: Sets and maintains high performance standards for self and others that support the organization's strategic plan and holds self and other team members accountable for achieving results; ensures organizational systems, processes and people are aligned to support strategic objectives; regularly evaluates self and team on goal attainment, processes used to achieve goals, and competitive benchmarks.
Managing Change: Helps employees develop a clear understanding of what they will need to do differently as a result of changes in the organization; establishes structures and processes to plan and manage the orderly implementation of change; helps individuals and groups manage the anxiety associated with significant change; facilitates groups or teams through the problem-solve and creative-thinking processes leading to the development and implementation of new approaches, systems, structures and methods.
Managing Vision & Purpose: Communicates a compelling and inspired vision or sense of core purpose; talks beyond today; talks about possibilities; is optimistic; creates mileposts and symbols to rally support behind the vision; makes the vision sharable by everyone; can inspire and motivate entire units or organizations.
Strategic Agility: Sees ahead clearly; can anticipate future consequences and trends accurately; has broad knowledge and perspective; is future oriented; can articulately paint credible pictures and visions of possibilities and likelihoods; can create competitive and breakthrough strategies and plans.
Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
The expected base pay range for this position is $160,000 - $190,000. Please note that base pay offered may vary depending on factors including job-related knowledge, skills, and experience.
This position is eligible for a bonus in accordance with the terms of the applicable program. Bonuses are awarded at the Company's discretion.
EEO Statement:
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.?
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
