Sr. Manager Manufacturing Engineering
About The Position
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.
Requirements
- BS in Mechanical, Chemical, Industrial or Electrical Engineering or related field. MS in Engineering preferred.
- 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.
- 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
Nice To Haves
- PE, CEM, Stationary Licensing as appropriate
- 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.
Responsibilities
- Year-Over-Year Improvement in Functional Organizational Structure & Capabilities
- Talent Portfolio that Ensures Achievement of Organizational Objectives
- Critical Talent Retained
- Organizational Structure that is “fit for purpose”
- Functional Area Budgets that Make Appropriate Trade-offs
- Critical Business Decisions
- Employees Aligned to Vision, Direction and Goals
- Champion Change & Innovation
- Role Model for Core Values
- Facilities and Production-Related Equipment Optimized to Meet Company Objectives
- Site Capital Master Plan that Ensures Capacity to meet Mallinckrodt Strategy
- Capital Projects Achieve Required Return on Investment
- New Product Feasibility Recommendations
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What This Job Offers
Job Type
Full-time
Career Level
Manager
