Process-Project Engineer 3, Chemistry Mfg Ops

Promega•Madison, WI

24d•Onsite

About The Position

The Promega Chappelle Manufacturing Center team consists of innovative professionals with diverse skillsets who work together to achieve our goal to safely manufacture high-quality small molecules that are used in Promega’s Life Science products to improve lives around the globe. To achieve this goal, we build strong relationships, collaborate openly, and embrace an attitude of “How can we do this the right way?” when we face challenges. We believe that to succeed as a team we need to create a space of optimistic learning and shared belonging, leveraging each other’s strengths and celebrating our differences. We are looking to build our team with members who share these values and who are inspired to take on the new opportunities that inevitably await! As part of the engineering team, you will be responsible for the manufacturing equipment, working to ensure reliable operation and troubleshooting issues to minimize production downtime. In this role, you will serve as the subject matter expert on these systems, providing guidance on system design and driving operational optimization across the plant. This role also will contribute to the execution of capital projects relating to drug product equipment, including encapsulation, primary and secondary packaging, and serialization. You will contribute both independently and as part of cross-functional teams, applying your technical expertise to execute projects and enhance overall plant performance. Identify and execute capital projects and continuous improvement projects related to process and process utility systems for small molecule synthetic organic chemistry and active pharmaceutical ingredient (API) manufacturing. Support transfer of new processes from development into manufacturing and provides ongoing manufacturing troubleshooting as needed.

Requirements

B.S. in Chemical Engineering or related discipline.
Minimum of 5 years engineering experience in small molecule synthetic organic chemistry, active pharmaceutical ingredient (API), fine chemical, or biotechnology manufacturing environment.
Advanced technical knowledge and experience with small molecule organic chemistry and active pharmaceutical ingredient (API) manufacturing equipment and utility systems, such as chemical reactors, filters, dryers, vacuum pumps, scrubbers, purified water, compressed gases and engineered heat transfer fluid systems.
Demonstrated experience managing complex engineering projects with little daily instruction and receiving only general guidance and vision on new projects and assignments.
Strong organizational and communication skills and a demonstrated ability and desire to share experience and knowledge with team members.
Ability to handle both multiple and changing priorities with assigned timelines, budgets and resources.
Strong safety mindset.
Outstanding critical thinking and troubleshooting skills.
Excellent oral and written communication skills.
Effective communicator in cross-functional environment.
Successful in implementing ideas and influencing people in a team environment.
Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

Nice To Haves

Engineering experience in pharmaceutical drug product, sterile fill/finish, oral solid dosage
Engineering project experience in technical lead or project management roles.
Expertise with hazardous material storage, handling and disposal, Process Hazard Analysis methodologies, code compliance and hazardous electrical area classification.
Experience designing and implementing engineering controls for containment of highly potent active pharmaceutical ingredients.
Experience with cGMP practices within an FDA-regulated industry.
Experience in design or continuous improvement of manufacturing processes, equipment and utility systems.
Experience in use of processes such as Lean manufacturing, Six Sigma, FMEA, DOE, etc.

Responsibilities

Leads mid-size projects and participates on large projects, collaborating in cross-functional teams to develop project drivers and business justification, evaluate options, and develop project scope, schedule and budget.
Communicates and presents project status reports to company personnel and leadership.
Monitors project progress and works with team members and company leadership to address issues.
Works independently and in teams to develop engineering documents, such as process descriptions, user requirements, mass balances, flow diagrams and piping and instrumentation diagrams.
Initiates and executes continuous improvement projects.
Coordinates cross-functionally to identify, prioritize and implement process improvement plans identified for manufacturing of products.
Determines the business case to support new production processes or equipment and participates in analysis for capital project justification.
Leads the design, configuration and start-up of new manufacturing processes, equipment and utility systems, including technology transfer and support of qualification activities.
Utilizes troubleshooting methodologies (e.g. DMAIC, RCFA, FMEA, Fish-Bone diagrams, 5 Whys, etc.) to investigate issues with process equipment, utility systems and automation systems.
Stays current on trends and technology advancements within the active pharmaceutical ingredient (API) and fine chemical industries through internal and external networks and areas of influence and expertise.
Demonstrates inclusion through their own words and actions and is accountable for a safe workspace.
Acts with kindness, curiosity and respect for others.
Embracing and being open to incorporating Promega’s 6 Emotional & Social Intelligence (ESI) core principles in daily work.
Understands and complies with ethical, legal and regulatory requirements applicable to our business.