(Archived) Manager, Production Refining & Engineering

SUMMARY: The incumbent oversees the operation of Lasalocid and CTC Refining manufacturing equipment. This position also leads the multi-site engineering efforts at Willow Island, WV, Salisbury MD, and Eagle Grove, IA, including installation of equipment and start-up and validation of the process. The position provides technical expertise to production units at the Willow Island site, Eagle Grove, and Salisbury sites and coordinates site engineering efforts while controlling capital spending. This position supports the Operational Excellence program within Willow Island Operations.

QUALIFICATIONS: The incumbent must demonstrate expertise in related engineering disciplines, manufacturing processes, and Lean Six Sigma principles. The incumbent must also demonstrate:

• Ability to provide necessary leadership and direction to team members to manage divisional engineering projects.
• Ability to independently plan and execute projects.
• Excellent oral and written communication skills.
• Ability to clearly present ideas to project teams, Managers, and Senior Leadership.
• Leadership skills to effectively manage multiple projects, potentially at multiple sites,
• Knowledge of manufacturing, process control instruments and systems, and related engineering disciplines
• Advanced material and problem-solving ability,
• Proficiency with Microsoft Applications (Excel, Word, Powerpoint) and Project Software.
• Strong expertise in PSM oversite including PHAs, 3 year reviews, Change Management, and other aspects of the OSHA 1910.119 standard

EDUCATION and/or EXPERIENCE:

Bachelor's degree (BS) in Engineering or related technical degree from a four-year college or university and greater than 5-7 years’ experience in Manufacturing/Engineering/Project Management, preferably in the Pharmaceutical (FDA regulated)/Chemical industry. Certification as a Lean Six Sigma Black Belt is a plus.

ESSENTIAL DUTIES AND RESPONSIBILITIES include the following (other duties may be assigned):

Production Refining

• Oversee the Lasalocid and CTC refining process including operator oversite, PSM program oversite and ownership for the WI site, and FDA compliance.
• Conceive, plan, develop, and evaluate technical and business projects in the production areas.
• Identify and implement productivity improvements for the refining process.
• Manage budget and control expenses.
• Identify, implement and monitor cost reduction programs.
• Interact with raw material suppliers to ensure robust supplies that are cost effective.
• Prepare, review, and provide managerial guidance for the preparation of documents to meet regulatory and departmental requirements.
• Interface with the appropriate regulatory and compliance agencies (i.e. FDA), as needed.
• Organize, interpret, and present data from production runs.
• Work closely with Production operations through hands-on intervention and involvement.
• Empower the process team to improve reliability and productivity by training, coaching and follow-through.
• Interface with analytical, microbiology, fermentation, other sites and functions as needed.
• Ensure safety, environment, corporate quality, and GMP compliance in the pilot plant

Start-up of New Projects/Equipment

• Coordinates the implementation and startup of new projects or equipment and will supervise the work performed by Engineers and employees assigned to the project.
• Accountable for project plans, milestones, critical tasks, and performance against project plan.
• Ensures conformance of installation to specifications prepared in initial design.
• Effectively works with outside contractors as needed to oversee project schedules.
• Observes, analyzes, and interprets results and data from equipment/process operation.
• Accountable for start-up verification and testing of units to pass production regulation requirements; identifies implications in terms of consistency and regulatory compliance
• Assists Maintenance function with establishing and maintaining preventative maintenance programs for manufacturing equipment.
• Ensures proper monitoring, documents and analysis of equipment test results are completed and addresses issues as required.

Operational Excellence/ Optimize Production:

• Supports Operational Excellence program efforts on site and within the network.
• Monitors production trends by statistical analysis; reacts to problems, trends and opportunities.
• Conceives, plans, develops, and recommends approaches to implement projects for optimizing production capacity/capability in a manufacturing process.
• Coordinates with Production, Microbiology Lab and Maintenance Departments to develop strategies to increase production, i.e. improvement of potencies, cost reductions, process control.

Project Management

• Effectively creates and leads project teams from concept to completion.
• Responsible for site capital budgets (WI, SB, and EG) including projects ranging from $5,000-$5,000,000. Responsible to ensure these threes sites spend to their capital budget with working and on-time capital projects
• Prepares engineering estimates and capital requests to obtain financial approval, supplying basic process data on which capital investment and manufacturing decisions can be made.
• Ensures detailed design specifications from which practical, functioning systems or equipment can be built.
• Interfaces with Engineers, Production, Maintenance, and Plant laboratories to coordinate capital project work on site. Serves as the site’s primary contact to Operational Excellence and Global Engineering.

Other Duties

• Solves technical/operational problems related to a manufacturing process.
• Provides engineering expertise to manufacturing and serves as a subject matter expert.
• Assists process teams in setting, tracking, and meeting team goals.
• Promotes teamwork and cooperation across the organization.
• Adheres to equipment/material specifications and maintains updated engineering documentation (drawings, prints).

• Stays current with latest engineering developments and communicates to others in the engineering community.

TECHNICAL SKILLS:

• Coaching, mentoring and teaching abilities
• OSHA 1910.119 Subject Matter Expert
• PHA Leader training preferred
• Change agent with strong credibility.
• Ability to lead and motivate teams to solve complex problems
• Ability to write engineering reports, capital project justifications, and correspondences.
• Proven ability to work on cross functional and multi-cultural teams
• Solid business/financial & project management skills
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, blueprints, and procedure manuals.
• Ability to speak effectively before project review committees, customers, employees of the organization, management, and Senior Leadership.

SUPERVISORY RESPONSIBILITIES:

This position will supervise individual engineers, operators, project teams and/or contractors.