We are currently seeking a dynamic, highly motivated, and experienced individual for the position of Sr Engineer I, CMC Engineering. The Sr Engineer, CMC Engineering will perform equipment support activities and provide engineering technical support to the manufacturing and utility areas of Sumitomo Pharma America, Inc.’s new cGMP manufacturing facility in Morrisville, NC. The role will be critical for start-up and on-going operations of the manufacturing facility. The role will require onsite presence in support of the facility and will need to be available after hours for on-call rotation. The Sr Engineer reports to the Senior Director of Engineering & Validation in the CMC Organization.
Job Duties and Responsibilities
Troubleshoots equipment systems and associated automation systems for production and utility equipment.
Identifies and leads equipment related capital projects.
Directs and supports the design, specification, and installation of new or modified equipment.
Develops and supports equipment commissioning and validation activities.
In collaboration with the Quality Assurance department, ensures that all activities are executed in compliance with regulatory guidelines.
Develops preventative maintenance and calibration requirements for new equipment and instruments.
Maintains personal training and goal development/completion.
Manages and provides direction to contractors.
Ensures production equipment meets cGMP’s and are regulatory inspection ready. Support investigations and associated CAPAs as required.
Contributes to risk analysis and mitigation plans to ensure product quality.
Works closely with cross-functional teams (e.g., manufacturing and quality) to meet production and project milestones.
Supports Environmental, Health, and Safety projects and initiatives.
Utilizes project management tools such as schedules, action lists, and clear scope definition to ensure the timely implementation of equipment improvements and compliance task (e.g., change controls, investigations, and corrective and preventative actions).
Regularly communicates with internal and external stakeholders including presentation of initiatives to senior management.
Education and Experience
Minimum of 4 years of relevant pharmaceutical/biotechnology experience.
Bachelor’s degree in Chemical Engineering, Biochemistry, Pharmaceutical Sciences or equivalent
Experience with sterile or aseptic processing equipment and GMP manufacturing is required.
Experience supporting isolator technology and associated air handling equipment is preferred.
Experience with contractor management is preferred.
Ability to work on-site and periodic on-call availability is required.
Disclaimer: The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed.
The base salary range for this role is $140,000 to $150,000. Base salary is part of our total rewards package which also includes the opportunity for merit-based salary increases, short incentive plan participation, eligibility for our 401(k) plan, medical, dental, vision, life and disability insurances and leaves provided in line with your work state. Our robust time-off policy includes unlimited paid time off, 11 paid holidays plus additional time off for a shut-down period during the last week of December, 80 hours of paid sick time upon hire and each year thereafter. Total compensation, including base salary to be offered, will depend on elements unique to each candidate, including candidate experience, skills, education and other factors permitted by law.
Confidential Data:All information (written, verbal, electronic, etc.) that an employee encounters is considered confidential.
Compliance :Achieve and maintain Compliance with all applicable regulatory, legal and operational rules and procedures, by ensuring that all plans and activities for and on behalf of Sumitomo Pharma America (SMPA) and affiliates are carried out with the "best" industry practices and the highest ethical standards.
Mental/Physical Requirements: Fast paced environment handling multiple demands. Must be able to exercise appropriate judgment as necessary. Requires a high level of initiative and independence. Excellent written and oral communication skills required. Requires ability to use a personal computer for extended periods of time.
Sumitomo Pharma America (SMPA) is an Equal Employment Opportunity (EEO) and Affirmative Action employer
Sumitomo Pharma America (SMPA) is committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
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