The position is responsible for performing microbiological analyses, in process bioburden testing, final product endotoxin and sterility testing, investigate out-of-limit or out-of-specification test results, and provide lab support for validation and business development activities.
II. Specific Duties, Activities, and Responsibilities:
Shift: Applicant must be willing to work one of the following shift options
- Compile and interpret results of microbiology and environmental monitoring tests and results.
- Maintain, clean, and sterilize laboratory instruments and equipment.
- Conduct chemical and physical laboratory tests to assist scientists in making qualitative and quantitative analyses.
- Robust understanding of the regulatory requirements.
- Able to compose robust investigations for microbiology, environmental monitoring and support of manufacturing investigations.
- Write technical reports or prepare graphs and charts to document experimental results.
- Perform water sampling, including DI water, WFI and steam
- Perform sterility testing of finished product
- Perform bioburden testing of raw materials, WFI and bulk product
- Perform bacterial endotoxin testing of WFI and bulk product
- Subculture and characterize microbial isolates using the Gram stain and differential tests such as the catalase and oxidase reaction, prepare shipments of subcultures for identification
- Perform growth promotion testing of liquid and plated media, including media fills
- Perform environmental monitoring of laboratory areas
- Perform bacteriostasis/fungistasis testing to validate test methods
- Process and incubate exposed biological indicators
- Incubate and read media fills
- Identifies micro-organisms by microscopic examination of physiological, morphological, and cultural characteristics.
- Receive and prepare samples and equipment for testing, including but not limited to finished product and bioburden
- Incubate and examine tests, including but not limited to bioburden, sterility, Bis and media fill units
- Enumerate bacteria; prepare shipments for outside laboratories
- Understand the science behind the above listed testing requirements, be able to clearly communicate testing requirements and expectations.
- Understand environmental monitoring, the different testing requirements and the interpretation of the results.
- Detail oriented to perform peer review of results, investigations and protocols.
- Operate and maintain laboratory equipment, including but not limited to incubators, autoclaves, ovens, vacuum pumps; assist with qualifications and validations
- Maintain current training status on equipment and procedures
- Perform documentation per cGMP; prepare and assist with preliminary and full investigations
- Support R&D and Technical Services activities
- Assist with FDA and customer audits
- Assist with and conduct studies as requested by the Lab Supervisor
- Maintain effectiveness of the Quality System components relevant to this position.
- Other duties as assigned.
- Sunday - Thursday (7:00am - 3:30pm)
- Tuesday - Saturday (7:00am - 3:30pm)
- B.S. in Microbiology or Biological Sciences
- 0-4 years experience
- Previous pharmaceutical experience desired.
- Demonstrated intermediate mathematical ability.
- High level of attention to detail.
- Excellent documentation skills.
- Strong Mechanical aptitude.
- Strong communication skills both written and oral.
- A full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software etc.) is preferred.
- Strong problem solving and analytical skills.
- Must possess appropriate communication skills allowing direct interaction with outside suppliers, STW internal Managers and Sr. Management.
- Works well in a team environment.
- Possess and demonstrate excellent verbal, written and interpersonal communications skills.
- Excellent problem solving and analytical skills.
- Well organized and detail and multi-task oriented.
- Works well under pressure and able to prioritize workloads.
- Must be able to interact effectively with a variety of individuals and personalities within and between departments.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Perform independent work related to projects and/or routine activities.
- Review reports, etc. for accuracy and logic.
- Meet deadlines and work under pressure with limited supervision.
- Must be able to perform risk assessments in a timely manner
- Must be able to communicate, both written and verbal form, in an effective manner.
- Must be able to multitask, be proactive and willing to take initiative and responsibility.
- Should be familiar with cGMP and safe work practices.
- Ability to read, comprehend, execute and communicate English written SOP’s.
- Be organized. Maintain good records, and be able to access them rapidly. Understand where information can be found.
- Be knowledgeable. Bring experience to the organization. Learn new skills; collect new information. Demonstrate a willingness to share skills and information with others.
- Make sound judgments. Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification. Act ethically.
- Demonstrate a bias toward action. Get things done. Be willing to take a position, and assert influence to drive improvement. Foster teamwork to get results.
- Ability to work within a controlled environment with gowning requirements
- Demonstrated ability to read, write, and speak clear English.
- Ability to stand for up to 8 hours per day
- Visual Acuity (20/30 corrected vision)
- May be exposed to inclement weather or be required to work in environments or under conditions that require the use of protective gear and/or awareness of personal safety and safety of others
- Frequent sitting, standing, walking, climbing ladders/steps, reading of written documents and use of computer monitor screen, reaching with hands and arms, twisting, writing, talking, bending, handling, turning, balancing, carrying, grasping, listening
- Occasional walking up inclines and uneven terrain, stooping, kneeling, crouching
- Frequent lifting and/or moving up to 20 pounds and occasional lifting and/or moving up to 30 pounds
Catalent Values and Competencies:
- Performance driven
- Customer focused
- Collaborative and inclusive
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs approximately 8,500 people, including over 1,000 scientists, at nearly 30 facilities across 5 continents and in Fiscal 2013 generated more than $1.8 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
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.
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.