Engineering Manager – Millsboro
Position Summary
The Engineering Manager will provide strategic and tactical engineering leadership for the Millsboro facility, supporting safe, compliant, and reliable operation of production and utility systems. This role is responsible for leading engineering resources and/or cross-functional project teams in the development, execution, and support of medium to large capital and maintenance-related projects, with project values ranging from approximately $50K to $60M.
The Engineering Manager will ensure alignment with site and corporate requirements for engineering, safety, environmental, quality, and regulatory compliance. The role will also support long-range capital planning, asset reliability, maintenance strategy, equipment/system performance improvement, and project turnover to operations and maintenance. This position will serve as a key technical and leadership resource for biological production systems, critical utilities, and related infrastructure supporting the Millsboro site.
Key Responsibilities
•Lead engineering activities for capital, maintenance, reliability, and infrastructure projects from concept through completion.
•Develop, review, and manage project scopes, budgets, schedules, and execution plans in accordance with site and corporate requirements.
•Partner with site leadership, operations, maintenance, quality, EHS, GES (global engineering supply) and finance to prioritize and execute engineering initiatives.
•Support and/or lead the development of long-range capital plans and site master planning activities.
•Oversee design, execution, commissioning, qualification, validation, and turnover activities for assigned projects.
•Provide engineering oversight for systems supporting biological production operations, including:
•bacterial and cell fermentation
•downstream processing
•biological containment
•decontamination systems
•sterile filling
•freeze drying
•packaging operations
•critical utilities
•Lead and coach engineering staff (team of 5), contractors, EPCMs, consultants, and vendors to ensure successful project delivery.
•Support maintenance strategy development, asset reliability improvements, and lifecycle management of equipment and systems.
•Ensure engineering solutions support equipment uptime, maintainability, safety, and operational efficiency.
•Drive root cause analysis, problem-solving, and corrective action implementation for chronic equipment or system issues.
•Ensure compliance with all applicable safety, environmental, quality, and code requirements.
•Manage quality change requests, safety MOCs, PHAs, ergonomic and industrial hygiene assessments, and related action plans as needed.
•Develop and/or approve engineering documentation, including:
•URS – User Requirement Specification
•FRS – Functional Requirement Specification
•DDS – Detailed Design Specification
•SOPs
•Energy control procedures
•Commissioning/qualification/validation protocols
•Review and approve technical documentation developed by external providers.
•Support equipment FAT/SAT activities and ensure proper documentation and follow-up actions.
•Coordinate contractor and end-user safety requirements, including Job Safety Assessments during construction and turnover.
•Review, verify, and approve supplier invoices, purchase orders, and change orders as delegated.
•Ensure drawings, asset documentation, and as-built records are updated accurately and maintained.
•Support project closeout, turnover, and depreciation profile assignment in coordination with Finance and Accounting.
•Train and develop user groups on system use, applications, and operational best practices where needed.
•Serve as a site technical liaison for internal stakeholders and potentially for other company facilities in the U.S. and globally.
Education Requirements
•Bachelor's degree in engineering required, preferably in one of the following:
•Mechanical Engineering
•Architectural Engineering
•Construction Science / Management
•Chemical Engineering
•Industrial Engineering
Required Experience and Skills
•10+ years of experience leading engineering projects and/or maintenance engineering activities in a highly regulated industry such as biotech, pharma, food, nuclear, or energy.
•Demonstrated experience managing projects in the $250K to $60M range.
•Strong problem-solving and root cause analysis skills with the ability to evaluate issues from multiple perspectives, including safety, compliance, automation, equipment, process, and people.
•Ability to read and interpret engineering documents, drawings, schematics, and technical specifications.
•Strong written and verbal communication skills.
•Proven leadership, teamwork, and cross-functional collaboration skills.
•Ability to work hands-on with production personnel, maintenance teams, and contractors in plant and field environments.
•Experience in FDA, USDA, and/or EU regulated environments.
•Proficiency with basic office software and ability to learn CMMS and other site systems to analyze maintenance history and support asset management activities.
•Willingness to work in environments that may include outdoor exposure, high noise, moving mechanical parts, and production-related chemicals.
Preferred Skills and Experience
•Experience in a USDA-regulated manufacturing environment.
•Lean Six Sigma training or certification.
•CAD and/or Bluebeam experience.
•Experience with CappApp and Steering Committee reporting systems.
•Experience leading maintenance or reliability improvement programs.
•Experience in capital planning, asset lifecycle management, or engineering leadership.
Additional Notes
•Position location: Millsboro
•Travel: less than 10%
Compensation
The salary range for the primary location of this role is $106,200.00 - $167,200.00. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
Other Conditions
•Employee Status: Regular
•Relocation: Domestic
•Visa Sponsorship: Yes
•Travel Requirements: 10%
•Shift: 1st - Day
•Valid Driving License: Yes
