Process Engineer
Catalent Pharma Solutions - Saint Petersburg, FL

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Catalent Pharma Solutions (a Blackstone Group company) is a leading Drug Development, Advanced Delivery Technology and Supply partner to the global pharmaceutical industry. A Fortune 1000 company, with over 20 locations on 5 continents, we partner with 90 out of the top 100 pharmaceutical companies and 44 of the top 50 biotech firms, as well as thousands of small innovator companies.

I. Position Overview:
Catalent is a leading provider of advanced technologies and outsourced services for the pharmaceutical, biotechnology and consumer health industry. Catalent develops, manufactures and packages pharmaceutical and other products for customers in nearly 100 countries, employs approximately 10,000 people at more than 30 facilities worldwide and generates more than $1.7 billion in annual revenue. Among its core offerings, develops and manufactures oral pharmaceuticals in nearly all major dosage forms, and offers proprietary technologies used in many well-known prescriptions and over-the-counter products.

The position is responsible for optimizing existing commercial drug product formulation, tech transfers, technical production support, and participating in the development of new drug processes including process engineering responsibilities. The position is also responsible for the implementation of process analytical technology (PAT) solutions.

II. Specific Duties, Activities, and Responsibilities:
  • Work with internal customers to improve key commercial processes by providing engineering technical guidance to production teams.
  • Manage process improvement projects for existing commercial processes.
  • Provide technical contribution in the development of scaleable, robust processes that meet requirement specifications.
  • Provide technical contribution in the specification of process equipment to be used in pilot plant and at commercial scale to be used for feasibility, clinical, registration, and validation batches.
  • Technical contributor on multi-disciplinary project teams
  • Work on complex problems of diverse scope where analysis of data requires evaluation of intangible factors. Exercise independent judgment in developing methods, techniques and evaluation criteria. Demonstrate success in technical proficiency, collaboration with others and independent thought.
  • Define critical process parameters, operational ranges and acceptance for sterility assurance validation and process validation activities.
  • Document process development as necessary in R&D notebooks, engineering studies, test runs, feasibility studies, and other means of GMP documentation.
  • Consult with external resources as necessary to ensure appropriate knowledge base is established for decisions.
  • Comply with Health, Safety and Environmental responsibilities for the position.
  • Design (including all required calculations, sizing, and development of all relevant specifications), install, and commission new process equipment in support of aseptic processing including stainless steel vessels, stainless steel tubing, fittings, sanitary valves, filter housings, steam traps, instruments and gages, etc.
  • Write engineering specifications for the various facets of the process integration including, pneumatics, electronics, controls, etc.
  • Troubleshoot technical issues related to sterile/sanitary process, investigating process problems, and preparing appropriate reports on findings.
  • Consult with external resources, guidance documents, standards, and regulations as necessary to ensure appropriate knowledge base is established for decisions.
  • Source and install new equipment and hardware required for existing process improvement projects.
  • Provide technical contribution in the development of scaleable, robust processes that meet requirement specifications.
  • Provide technical contribution in the specification of process equipment to be used in pilot plant and at commercial scale to be used for feasibility, clinical, registration, validation batches, and commercial batches.
  • Act as technical subject matter contributor on multi-disciplinary project teams.
  • Ensure that key milestones in agreement with sponsors are achieved and that projects are progressed in a timely manner. Communicate changes with sponsors and internal team members.
  • Maintain effectiveness of the Quality System.
  • Other duties as assigned.
Qualifications

Education or Equivalent:
·

Bachelor of Science in Chemistry/Pharmacy/Engineering or relevant discipline required.

·

Advanced degree in Science (Chemistry/Pharmacy/Engineering) or relevant discipline desired.

Experience:
·

Minimum of 1-5 years relevant experience in pharmaceutical drug product manufacturing relevant to degree.

Experience may be waved for PhD candidates.

Engineering or advanced degree preferred.

·

PhD (science): 1+ years of industry experience is required along

with

writing of technical and validation protocols and reports

.

·

MS

(

science/engineering): 3+ years

of industry experience is required including experience in pharmaceutical development along with

writing of technical and validation protocols and reports

.

·

BS (

science/engineering): 3+ years industry experience

experience is required including 1+ years experience in of pharmaceutical development developing products and processes along with

writing of technical and validation protocols and reports

.

·

Experience in pharmaceutical development a plus.

Knowledge/Skills Requirements:
·

Demonstrated advanced mathematical aptitude.

·

High level of attention to detail.

·

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, STP internal Managers and Sr. Management.

·

Ability to work independently on multiple projects.

·

Works well in a team environment.

·

Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

·

Must be able to perform risk assessments in a timely manner and act accordingly.

·

Should be familiar with cGMP or be able to quickly learn and apply cGMP principals and must be able to follow safe work practices.

·

Demonstrate a willingness to share skills and information with others.

·

Blend knowledge and analysis with logic, active listening, and a continuing interest in simplification.

·

Demonstrate a bias toward action.

Getting things done.

Be willing to take a position, and assert influence to drive improvement.

Foster teamwork to get results.

Physical Requirements:
·

Ability to stand for up to 12 hours per day

·

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, stooping, kneeling, crouching, talking, bending, grasping, listening

·

Occasional, walking up inclines and uneven terrain, writing, carrying,

·

Frequent lifting and/or moving up to 30 pounds and occasional lifting and/or moving up to 50 pounds

Business Environment:
·

Fast-paced

·

Performance driven

·

Customer focused

·

Collaborative and inclusive

Catalent Pharma Solutions - 19 months ago - save job - block
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About this company
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Catalyst + talent = Catalent. At least, that's the brand Catalent Pharma Solutions is using to try to ensure its customers'...