Project Engineer

Catalent • Philadelphia, PA

4h • Onsite

About The Position

Project Engineer Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm 100% on-site Catalent’s 206,878-square-foot Philadelphia-area facility serves as the global Center of Excellence for Clinical Supply Packaging, offering GMP secondary packaging and clinical labeling services. The site provides manual to fully automated packaging solutions, including temperature-controlled options for sensitive products. The Project Engineer meets cGMP (current Good Manufacturing Practices) expectations. Provides support for the design, installation, start-up, validation and operation of facility and/or process equipment. The Role: Prepare requests for quotation based on User Requirements Specifications (URS) for multiple bidders for facility & equipment products Work with operations, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment Stay current on existing technology by meeting with vendors and manufacturers in order to evaluate new equipment and procedures Define, describe, evaluate, and effectively communicate facility & equipment requirements to both technical experts and non-technical audiences Will assist in synchronizing site functions through all phases of continuous improvement projects including new assets Responsible for the administration, implementation, and project management of assigned projects, including conformance with equipment and systems performance criteria All other duties as assigned The Candidate: A minimum of a High School Diploma or GED is required; Bachelor’s Degree in Architectural, Chemical, Electrical, Civil, and Mechanical Engineering is preferred. Minimum of 3 years of experience in related field or comparable experience is required Development, manufacturing or packaging for clinical/commercial drug products or combination products in a cGMP controlled environment experience is preferred Knowledge of change control and validation, preferred, including experience with equipment FAT, Commissioning, IQ, OQ, PQ and development of qualification protocols/reports for packaging and shipping activities is preferred Knowledge regarding design control, documentation, risk management and processes such as FMEA, Design Verification and URS is a plus May be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety to others Why you should join Catalent: Defined career path and annual performance review and feedback process Diverse, inclusive culture Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 hours of PTO + 8 paid holidays Generous 401K match Medical, dental and vision benefits Tuition Reimbursement - Let us help you finish your degree or start a new degree! 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. 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 [email protected] . 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 [email protected] for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE .

Requirements

• A minimum of a High School Diploma or GED is required; Bachelor’s Degree in Architectural, Chemical, Electrical, Civil, and Mechanical Engineering is preferred.
• Minimum of 3 years of experience in related field or comparable experience is required

Nice To Haves

• Development, manufacturing or packaging for clinical/commercial drug products or combination products in a cGMP controlled environment experience is preferred
• Knowledge of change control and validation, preferred, including experience with equipment FAT, Commissioning, IQ, OQ, PQ and development of qualification protocols/reports for packaging and shipping activities is preferred
• Knowledge regarding design control, documentation, risk management and processes such as FMEA, Design Verification and URS is a plus
• May be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety to others

Responsibilities

• Prepare requests for quotation based on User Requirements Specifications (URS) for multiple bidders for facility & equipment products
• Work with operations, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment
• Stay current on existing technology by meeting with vendors and manufacturers in order to evaluate new equipment and procedures
• Define, describe, evaluate, and effectively communicate facility & equipment requirements to both technical experts and non-technical audiences
• Will assist in synchronizing site functions through all phases of continuous improvement projects including new assets
• Responsible for the administration, implementation, and project management of assigned projects, including conformance with equipment and systems performance criteria
• All other duties as assigned

Benefits

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• 152 hours of PTO + 8 paid holidays
• Generous 401K match
• Medical, dental and vision benefits
• Tuition Reimbursement - Let us help you finish your degree or start a new degree!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: High school or GED