Sr. Principal Engineer

Noven Pharmaceuticals - Miami, FL (30+ days ago)3.5


Job Description:
Job Summary / Objective
Provides functional leadership and technical expertise
for the design, implementation and qualification of new
technology for the manufacturing processes, site
utilities and facilities. Lead and develop a team of
engineers (manufacturing and qualifications) responsible
for sustaining commercial activities and/or product
development projects with a vision of a quality by
design culture and continuous improvements. Assists
manufacturing operations, facilities and utilities team
in troubleshooting and problem solving with regards to
materials, components, equipment and systems. Develops
and recommends technologies to achieve cost
effectiveness, improved product quality and reliability.
Recommends processes for the production of therapeutic
products using tankage, piping, coating /oven systems,
laminating dies, pouching machines, packaging,
facilities and utilities (compress air, chillers,
cooling towers, HVAC, etc.) systems.
Essential Functions
  • Perform as extension of engineering leadership staff
providing direction to engineers and technicians,
helping define direction and serve as example of Noven’s
Mission, Values and Leadership Principles.
  • Lead a team of engineers-technicians from different
technical disciplines in broad areas of assignments.
Establishes operating equipment specifications, optimize
manufacturing techniques, improve equipment reliability
and establish automation technology road map.
  • Applies knowledge of engineering principles and
practices in broad areas of assignments and related
fields. Apply knowledge of compliance, risk management,
and good engineering practices.
  • Makes decisions independently on engineering problems
and methods, and represents the organization in
meetings, collaborations, conferences to resolve
important questions and to plan and coordinate work.
  • Requires the use of advanced techniques and the
modification and extension of theories, precepts and
practices of his/her field and related sciences and
disciplines. Knowledge of materials, their
chemical/structural properties, and material handling.
  • Supervision and guidance related largely to overall
requirements, critical issues, new concepts, and policy
matters.
  • Consults with supervisor concerning unusual problems
and developments.
  • Responsible for one or more of the following:
  • In a supervisory capacity, plans, develops,
coordinates, and directs large critical engineering
projects (process, packaging, utilities and facilities)
and/or a number of small projects with many complex
features from definition to its implementation.
  • As an individual researcher, carries out complex or
novel assignments requiring the development of new or
improved techniques or procedures. Provide technical
support for key projects or department initiatives.
  • Work is expected to result in the development of new
or improved techniques or procedures.
  • Work is expected to result in the development of new
or refined equipment, materials, processes, products,
and/or methods.
  • Assesses the feasibility and soundness of proposed
engineering evaluation tests, products or equipment when
necessary data are insufficient or confirmation by
testing is advisable.
  • Technically and/or directly supervise, coordinate and
review the work of engineers and technicians, estimates
manpower needs, project schedules and assigns work to
meet completion date.
  • Lead new technology and automation projects, hands-on
experience with PLC and SCADA software systems that
control both intermittent or continuous motion line
machines.
  • Practices company safety and quality policies and
procedures.
  • Responsible for ensuring personal and company
compliance with all Federal, State, local and company
regulations, code compliance, policies and procedures
for Health, Safety and Environmental compliance.
  • Responsible for the purchase or design of equipment
that meets health, safety and environmental standards
set by the company and or outside entities. Select and
monitor outside vendors, contractors; negotiate
fabrication contracts.
  • Responsible for performing design reviews and
pre-validation assessments to ensure the safe and
environmentally sound start-up of new processes.
Supervise and execute factory acceptance test (FAT),
site acceptance test (SAT), installation, commissioning
and qualification activities of new and existing
equipment.
  • Ensure equipment related information such as trends,
issues, availability, performance, and quality (OEE)
associated with machine maintenance, calibration and
spare parts requirements is properly analyzed and then
passed into the production, maintenance and calibration
organizations.
  • Draft, review, and approve master validation plans,
protocols, and reports for product life cycle and
sustaining commercial activities.
  • Support complaint investigations for root cause and
CAPA implementation with statistical and six sigma tools
to determine root cause.
  • Has direct financial responsibility for definition,
management and reporting of department’s capital and
spend budget.
Extensive knowledge of regulatory requirements and

engineering tools:
  • Risk Management (ICH Q9 or ISO 14971)
  • Draft, review, and approve master validation plans,
protocols, and reports for product life cycle and
sustaining commercial activities.
  • Support complaint investigations for root cause and
CAPA implementation with statistical and six sigma tools
to determine root cause.
  • Lean Six Sigma Principles and tools such as: Design of
Experiments, Root Cause analysis and/or Problem solving
approaches.
  • Strong understanding of GxP: Good Manufacturing
Practices (GMP), Good Laboratory Practices (GLP), Good
Documentation Practices (GDP); Project Management
principles; and ICH Q8, Q9, and Q10 procedures.
  • Certified Lean Six Sigma Green Belt or Black Belt
and/or Certified Quality Engineer (CQE) is strongly
desired. Proficiency with Microsoft Word, Excel, Power
Point and statistical software (e.g., Minitab) is
required. Strong communication skills are required.
Experience with organizational and operational
excellence principles, delegation, influencing,
strategic planning, and execution are desired.
Competencies

Judgment / Decision Making:
Must be able to work with little or no supervision.
Works on complex problems of diverse scope where
analysis of data requires an in-depth evaluation of
various factors. Exercises judgment within broadly
defined practices and policies in selecting methods,
techniques and evaluation criteria for obtaining
results. Work will often be performed within a cross
functional framework and will involve the development
and writing of quality policies, procedures, etc. A high
degree of original thinking, resourcefulness and
networking will be required to coordinate projects or
solve problems.

Financial Responsibility:
Substantial damage, loss and risk. Erroneous decisions
or recommendations or failure to get results would
normally result in serious program/project delay and
considerable expenditure or resources or losses to the
company bottom line. Prepare and manage capital and
expenses budget, supervise and maintain strict control.

Responsibilities for Contacts:
Frequent internal contact with all levels and functions
of personnel. Contact with vendors, customers, partners,
and Health Authority Inspectors during
audits/inspections to exchange information, coordinate
projects, and negotiate solutions.
The ability to work in and communicate well within a
team structure in multiple projects, with flexibility to
adapt to changing priorities is required. Must be able
to work in a fast paced environment, and have excellent
communication and emotionally intelligence skills.

Supervisory Responsibility:
Personnel evaluation and selection using established
Noven guidelines. Manage exempt, non-exempt and/or
hourly employees directly. Carries out supervisory
responsibilities in accordance with the organization's
policies and applicable laws. Demonstrated experience
making decisions around the prioritization and
assignment of work flow within the engineering services
group.
Ensure the success and development of individuals on the
project team by defining clear expectations, providing
timely and specific feedback and holding others
accountable. Hire, train, supervise, counsel and
evaluate direct-report employees; conduct and submit
annual performance appraisals; recommend/authorize pay
adjustments as appropriate.

Job Requirements:
Other Elements

Education & Experience:
Bachelor’s Degree in Electrical Engineering or
Mechanical Engineering. MBA is a plus and Ten (10+) or
more years of experience in a manufacturing operations
and/or engineering/validation role of increasing
responsibility, preferably in the pharmaceutical,
medical device manufacturing or healthcare environment.
Must possess the solid understanding of engineering
fundamentals, engineering best practices,
troubleshooting methodology, capital project management,
process-utilities equipment validation.
Good written and oral English communication skills.
Computer literate a must, strength with Statistics used
for Design of Experiments as well as MS Project and
Excel required. OEE (Overall Equipment Efficiency), Lean
Sigma, TQM, Project Management and PLC’s - Controls
experience a plus for executing smaller tasks, large
projects and initiatives. Experience with Business and
Technical systems such as TrackWise, Master Controls,
JDE, Minitab, AutoCAD and AutoDesk Vault a plus.
Travel: Minimal travel domestically and internationally
may be required; extra and unusual hours may be required
to meet project deadlines. Due to the nature and
complexity of our operations and safety requirements it
is required to be on call 24/7 per business needs.
Working Conditions
Environment: Time distributed between office and Product
Development / Operations / Facilities / Utilities
environment with exposure to moving parts, mechanical
rooms and noise.
Physical Demands: Regularly stands for more than two
hours at a time, with some stooping and bending. Visual
acuity and manual dexterity required to operate
computer, and proofread documents.
Others: Customer service / customer focus, excellent
attitude, teamwork and sense of urgency are very
important.
The above assignments are intended to describe the
general nature and level of work being performed by
people assigned to this job. They are not intended to be
an exhaustive list of all responsibilities, duties and
skills required.
Noven Pharmaceuticals, Inc. is an equal opportunity and
affirmative action employer which recruits, hires,
trains and promotes persons in all positions without
regard to race, color, religion, sex, national origin,
citizenship, disability, or veteran status or any other
legally protected status.