Validation Engineer I
Validation Engineer I
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Validation Engineer I
Position Summary
Catalent Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop manufacture and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma biotech and consumer health customers supporting product development launch and full lifecycle supply. With timetested experience in development sciences delivery technologies and multimodality manufacturing Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites Catalent supplies billions of doses of lifeenhancing and lifesaving treatments for patients annually.
Catalent Pharma Solutions is hiring a Validation Engineer I role. The Validation Engineer I is responsible for identification and implementation of preventative and predictive maintenance systems. This system is required to ensure that plant and facility equipment operate efficiently to minimize production interruptions and unscheduled downtime. The Validation Engineer I will conduct and/or assists in repairs (corrective maintenance) and preventive maintenance of process equipment building support and laboratory systems. Participate in rotations for afterhours facility and manufacturing support sometimes outside of standard shift hours or upon short notice.
This is a fulltime role position: Monday Friday Days. Onsite
Catalent is committed to a Patient First culture through excellence in quality andcompliance and to the safety of every patient consumer and Catalent employee.
The Role
Micronization and milling of both hazardous and nonhazardous pharmaceutical actives and excipients.
Set up operate equipment and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs).
Review documentation (batch records SOPs Logbooks) for completeness clarity accuracy and submit edits to documents for revision as required.
Ability to work in a regulated environment with adherence to standard operating procedures.
Capable of reading and following defined SOPs and policies and executes tasks accordingly.
Work in accordance with cGMP. Identify and communicate nonroutine events deviations and GMP deficiencies to supervisor in a timely manner.
Produce thorough clear & consistence documentation in compliance with Quality Standards (Attributable Legible Contemporaneous Original and Accurate).
Participate in shift change meetings site/team meetings sending/receiving emails offering suggestions for improvements and participating in projects.
All other duties as assigned;
The Candidate
Required a Bachelors Degree in Engineering or related technical discipline with minimum of two years mechanical experience in regulated GMP environment.
Experience in troubleshooting calibration repair and testing of HVAC laboratory and utilities equipment required.
Prior micronization experience a plus.
Previous experience with Blue Mountain Regulatory Asset Manager System is a nice to have.
Wear a respirator and pass the required respiratory medical clearance.
Individual may be required to sit stand walk regularly and occasionally lift up to 50 pounds
Why you should join Catalent:
Defined career path and annual performance review and feedback process
Diverse inclusive culture
Positive working environment focusing on continually improving processes to remain innovative
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO 8 paid holidays
Several Employee Resource Groups focusing on D&I
Dynamic fastpaced work environment
Community engagement and green initiatives
Generous 401K match
Medical dental and vision benefits effective day one of employment
Tuition Reimbursement Let us help you finish your degree or start a new degree!
WellHub program to promote overall physical wellness
Perkspot offers exclusive or private discounts from approximately 900 merchants in a wide array of categories
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 lifesaving and lifeenhancing 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 . 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 for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE.
Employment Type
Full-Time
