Mgr Professional Proc Engineer MAP Mod 1

USE YOUR POWER FOR PURPOSE

ROLE SUMMARY

Provides technical expertise and operational support for Drug Product Operations and specifically the new Modular Aseptic Processing (MAP) Mod 1 facility. This position will support the capital project from an Operational Readiness standpoint in Formulation and Dispensing will include partnering with OEM vendors automation engineering verification and quality to ensure the facility meets operational quality and EHS position will transition to an operations support role after regulatory approval. Partners with shop floor colleagues and supervision to ensure smooth and efficient production of a diverse mix of products. Assists in equipment troubleshooting activities as needed. Serves as a subject matter expert within the site for highly automated aseptic formulation and dispensing systems. Responsible for technical development of junior colleagues.

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability engineering is crucial to ensuring that customers and patients receive the medicines they need precisely when they need them. By collaborating with our forward-thinking engineering team you will contribute to delivering medicines to the world at an accelerated pace by envisioning new possibilities and taking decisive action. Your role in the design and development of manufacturing processes as well as in maintenance and reliability support is essential for providing timely access to necessary medications. Working alongside our innovative team you will help expedite the delivery of medicines globally by imagining what can be achieved and making it happen.

ROLE RESPONSIBILITIES

• Develop User Requirements for OEM equipment and highly automated systems.

• Support capital project from an Operational Readiness standpoint to include Verification and Testing support SOP development Training and IMEx deliverables.

• Develops and validates manufacturing processes for drug products taking into consideration problems inherent in the transfer of technology from research to production from other sites or within the site.

• Collaborates with and influences other enabling departments (Quality Engineering Maintenance etc.) to assure initiatives are successful.

• Develops and validates manufacturing processes for drug products taking into consideration problems inherent in the transfer of technology from research to production from other sites or within the site.

• Conducts tests and measurements throughout stages of production to determine control over applicable variables.

• Investigates deviations that occur on the manufacturing floor. Performs root-cause analysis and identifies appropriate effective corrective actions. Implements corrective actions in conjunction with the appropriate enabling groups i.e. engineering maintenance quality validation environmental health and safety.

• Leads technical improvement projects aimed at defect reduction improved equipment reliability and better equipment utilization.

• Provides concise and thorough updates on initiatives to site leadership.

• Mentors junior level colleagues inside and outside of department.

WHAT YOU WILL ACHIEVE

In this role you will:

• Provide comprehensive testing and technical support for new manufacturing facilities and processes.

• Facilitate and manage process and component improvement projects as needed.

• Assess manage and report on the process capabilities of operational equipment and services.

• Oversee and conduct supplier technical audits and corporate audits.

• Actively share knowledge within the team through established systems.

• Apply technical expertise in Operations Quality and Validation to recommend improvements considering business challenges.

• Lead cross-functional project teams through high-risk technical assessments and develop complex engineering solutions.

• Provide guidance and lead moderately complex projects managing time and resources effectively.

• Apply skills and discipline knowledge tocontribute to departmental work and make decisions to resolve moderately complex problems.

• Work independently review own work mentor colleagues and exercise judgment utilizing knowledge and experience.

HERE IS WHAT YOU NEED (Minimum Requirements)

• Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience.

• Demonstrated experience in product development manufacturing science and technology sterilization or process validation or Process Engineering within the pharmaceutical industry.

• Thorough knowledge of cGMP (current Good Manufacturing Practices) combination device regulations and design control.

• Strong history of problem-solving skills project and task management skills.

• Ability to manage priorities and lead others under pressure.

• Strong verbal and written presentation communication skills.

BONUS POINTS IF YOU HAVE (Preferred Requirements)

• Relevant experience in the pharmaceutical industry.

• Proven ability to work collaboratively in a cross-functional team environment.

• Strategic planning and forecasting skills.

• Ability to facilitate agreements between various teams.

• Experience using common AI tools including generative technologies such as ChatGPT or Microsoft Copilot to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices includingrisk management and ethical use.

• Specific knowledge of and experience with Drug Product processing and equipment in highly automated aseptic preparation formulation filling isolator or lyophilization systems is highly desirable.

PHYSICAL/MENTAL REQUIREMENTS

Job will include standing walking and sitting. Occasional lifting may be required.

Grade C & D gowning training will be required.

Job may also require occasional weekend/evening work supporting a 24-hour/7-day operation.

NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 10% domesticand/or international travel

OTHER JOB DETAILS

Relocation support available
Work Location Assignment:On Premise

Last Date to Apply for Job:April 27 2026

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN O-1 H-1B etc.) is not available for this role now or in the future.