Process Engineer

The purpose of this position is to drive improvements throughout manufacturing centered on safety, compliance, product quality, throughput, and yields. The Operations Process Engineer is responsible for identifying, leading, and driving process improvements related to the above goals.

Specific Tasks, Duties and Responsibilities:

RESPONSIBILITIES INCLUDE, BUT ARE NOT LIMITED TO:

• Identifies and leads process improvement initiatives to provide significant business value impacts in Safety, Quality, Delivery, and Cost.
• Utilizes lean six sigma tools including but not limited to GEMBA, value stream mapping, process mapping, optimization studies, kaizens, etc.
• Responsible for facilitating investigations into production related deviations of batches, preps, lots, equipment, and facilities to ensure all cGMPs, SOPs, product registrations, and customer requirements are met. Responsible for aiding in the development and execution of CAPAs in Trackwise.
• Requires a passion for problem solving, attention to detail, good organizational skills, a sound understanding of cGMPs and Manufacturing. Developed critical thinking skills are also required.
• Represents the production department on various project teams such as validation, engineering phase review meetings, and daily department communication meetings. May also assist in developing and maintaining various quality and training systems and programs.
• Build solid cross functional relationships and work effectively with the operations personnel, QA, Process Engineers, Manufacturing Services, Materials Management, Scheduling, Maintenance, Quality Control, QA Regulatory, Engineering, and Customers.
• Provides operational management information by collecting, analyzing, and summarizing operating, engineering, compliance, safety, and fiscal data and trends.
• Communicate effectively potential projects and project outcomes and results through visual, oral, and written forms.
• Ability to backfill production manager positions when needed.

Essential Skills and Experience:

Education or Equivalent:

• Bachelor’s Degree (Science or Engineering preferred)
• Lean Six Sigma certification preferred.
• Minimum 3 years in related role preferred.

Knowledge/Skills Requirements:

• Exemplary project management and organizational skills.
• Exemplary oral and written communication skills.
• Working knowledge of cGMPs and regulations.
• Strong analytical skills.
• Proficiency in Microsoft Word, PowerPoint, Excel, Access. Knowledge of Trackwise software is a plus.
• Maintains current knowledge of cGMP regulations and regulatory trends as they pertain to the stated responsibilities.
• Ability to work cross functionally and build strong working relationships.

Physical Requirements and Safety Considerations of the Position:

Physical Requirements:

Individual may be required to sit or stand for extended periods. Specific vision requirements include reading of written documents and use of a computer monitor screen frequently.

Work Schedule:

Shifts of 8 or 12 hours in duration.

Essential Physical Job Tasks:

• Completion of administrative duties as indicated by position
• Data entry and use of computer user interface tools including mouse, keyboard, and any other applicable instruments .
  
• Sustaining static postures
  • Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position.
  • Static stance/standing as required
• Lifting and operating in an office environment
  • File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary.
  • Infrequent lifting overhead reaching less than or equal to 15 lbs with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.

Safety Considerations:

• Must follow any applicable plant safety requirements.

Environmental Conditions:

• Working conditions will be Heating, Ventilation and Air Conditioned controlled.

About Catalent

Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients globally. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients around the world.

Catalyst + Talent. Our name combines these ideas. From drug and biologic development services, to delivery technologies to supply solutions, our highly skilled and dedicated global team of over 9,500 is passionate about improving health and wellness by combining their personal expertise and advanced technologies to advance science and supply products of the highest quality to customers and patients around the world.

Our VISION is to be the world’s most trusted, reliable and innovative drug development and delivery partner by upholding the highest industry standards and exceeding customer expectations while driving strong, sustained growth for the company.

Our MISSION is to develop, manufacture and supply products that help people live better, healthier lives.

OUR VALUES are at the foundation of everything we do:

• Patient First: We put patients at the center of our work to ensure the safety, reliable supply and optimal performance of our products

• Customer Dedication: We strive to exceed our customers’ expectations every day

• People: We are committed to the growth, development and engagement of our people

• Innovation: We develop and apply innovative solutions, superior technologies and continuously improved processes

• Integrity: We demonstrate respect, accountability and honesty in every interaction

• Excellence: We have a passion for excellence in everything we do.

Catalent. More products. Better treatments. Reliably supplied.™

Visit www.catalent.com/careers to explore career opportunities, or contact us at +1 877 503 9493
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com . This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. If you would like to partner with Catalent to help us achieve our goals of hiring the best and the brightest talent, please email Erica.Kanka@catalent.com to learn more about becoming an approved vendor. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.