Continuous Improvement Operations Lead

Continuous Improvement Operations Lead
Position Summary
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.
The Continuous Improvement Operations Lead drives improvements throughout manufacturing centered on safety, compliance, product quality, throughput, and yields. The Continuous Improvement (CI) Operations Lead is responsible for identifying, leading, and driving process improvements related to the above goals.
The Role

• 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.
• Other duties as assigned.

The Candidate

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

Why You Should Join Catalent

• Several Employee Resource Groups focusing on D&I
• Employee Stock Purchase Program
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• Generous 401K match
• 152 hours accrued PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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. 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.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.