Technician II Central Services
Technician II Central Services
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Job Description
Technician II Central Services
Catalent Pharma Solutions is looking to hire a Technician II Central Services (Day Shift) to support our Gene Therapy Team in Harmans MD
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.
Our FDAlicensed stateoftheart CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from ourBaltimore location. The campus is close to Washington DCs I270 Technology Corridor top universities and government agencies. The Harmans/BWI1 EMA and FDA approved facility at approximately 200000 sq. ft. houses 10 CGMP manufacturing suites fill/finish central services testing labs and a warehouse. The Harmans/BWI2 facility at approximately 145000 sq. ft. is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.
TheCentral Services TechnicianII is responsible forsupporting themanufacturing processes in Central Servicesthrough the application of broad knowledge of theories and principles utilized to solve operational as well as routine tasks in the production of bulk biologics from microbial and cell culture systems for Phase I/II& commercialGMP manufacturing.
This position will take place on the day shift 7:00am7:00pm on a 223 rotation. It will require a rotating schedule that includes working Weekends.
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
- Completes Batch Production Records under cGMP and documents in detailthrough the use ofSOPs and BPRs for the processes and manufacturing steps
- Generates operational protocol(s) internal or external documentsincludingSOPs BPRs deviations and summary reports
- May work with Process Development team and collaborate with Manufacturing Sciences and Technology group to transfer new projects into GMP
- Generate and revise internal and external documents (SOPs BRs)
- Support initiation and closure of deviations; may serve as the lead in the departmental investigation and be responsible for closing out deviations and CAPAs
- Troubleshootprocess and equipment problems; Work with Facilities and Validation to maintain manufacturing equipment
- Develop creative solutions to operational problems by leveraging knowledge of available theories and proven solutions
- Work closely with production management for current and new manufacturing projects and help develop processes/techniques to meet contract objectives and avoid operational delays
- Work closely with various departments andaidother teamsas necessary
- Interact with clients during initial and subsequent manufacturing campaigns; may be responsible to oversee and escort the personinplant (PIP) during manufacturing campaigns
- Participate in facility expansion and equipment validation activities
- Other duties as assigned
The Candidate
- HS or GED with 24 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance OR
- Associate degree in a Scientific Engineering or Biotech field with 24 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance OR
- Bachelors degree in a Scientific Engineering or Biotech field with 12 years experience with upstream (fermentation/bioreactor) or downstream (column chromatography buffer/media skid) biologic production processes under GMP compliance
- Outstanding knowledge and ability to apply scientific principles utilized to solve operational as well as routine production tasks
- Excellent documentation skills including comprehension review & establishing Batch Production Records SOPs deviation & summary reports
- Thorough knowledge of current Good Manufacturing Practices (cGMPs) and all relevant safety procedures within the company. General understanding of most areas in Manufacturing and supporting functional groups.
- Must be teamoriented (proactively builds healthy working relationships between peers their department and other groups).
- Able to fluently communicate in English. Exhibits excellent written and oral communication skills.
- Possesses a basic knowledge of nonmanufacturing functions such as QC Regulatory QA and/or Materials Management.
- Ability to develop and maintain strong working relationships with primary support functions.
- Frequent standing walking bending. Must be able to lift up to 25 lbs.
The anticipated salary range for this position in Maryland is $47600 to $65450 plus shift differential and annual bonus when eligible. The final salary offered to a successful candidate may vary and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job type and length of experience within the industry skillset education business needs etc. Catalent is a multistate employer and this salary range may not reflect positions that work in other states.
Why you should Join Catalent
- Potential for career growth within an expanding team.
- Defined career path and annual performance review & feedback process.
- Crossfunctional exposure to other areas within the organization.
- Medical Dental Vision and 401K are all offered from day one of employment.
- 152 hours of PTO and 8 paid holidays.
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.
Required Experience:
IC
Employment Type
Full-Time
