Senior Project Engineer II - Process
Company: Takeda Pharmaceuticals International GmbH
Posted on: April 9, 2021
The health and safety of our employees and candidates is very
important to us. Due to the current situation related to the
Coronavirus (COVID-19), we're leveraging our digital capabilities
to ensure we can continue to recruit top talent at Takeda. As your
application progresses, you may be asked to use one of our digital
tools to help you through your recruitment journey. If so, one of
our colleagues will explain how these tools will be used during the
recruitment process. Thank you. *Please be aware of an Identity
Theft Scheme targeting individuals seeking jobs with Takeda and
other employers. See below or here for more info. Every day,
employees working in Takeda's Global Manufacturing and Supply
Chain, and Global Quality business unit are shaping the future of
healthcare. They are breaking down barriers and ensuring our
life-changing medicines are available, accessible, and affordable
to patients. Life-changing for you. Life-changing for patients.
Global Manufacturing and Supply Chain, and Global Quality is the
backbone of Takeda, and our employees are the guardians for our
patients, our products, and our reputation. As a member of our
team, we can offer you the opportunity to grow in a meaningful
career, develop your skills, and come to work every day knowing
that what you do makes a genuine difference. Success What makes a
successful member of our team? Check out the traits we're looking
for and see if you have the right mix. Job ID R0034336 Date posted
04/02/2021 Location Lexington, Massachusetts By clicking the
"Apply" button, I understand that my employment application process
with Takeda will commence and that the information I provide in my
application will be processed in line with Takeda's Privacy Notice
in my employment application is true to the best of my knowledge.
Job Description Are you looking for a patient-focused,
innovation-driven company that will inspire you and empower you to
shine? Join us as a Senior Project Engineer II - Process in our
Lexington, MA office. At Takeda, we are transforming the
pharmaceutical industry through our R&D-driven market
leadership and being a values-led company. To do this, we empower
our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers,
encourage innovation, and strive for excellence in everything we
do. We foster an inclusive, collaborative workplace, in which our
global teams are united by an unwavering commitment to deliver
Better Health and a Brighter Future to people around the world.
Position Overview: The candidate will be responsible for technical
leadership of equipment, automation and / or facility improvement
projects within operating commercial manufacturing facilities and
primarily focus on technical deliverables around
feasibility/conceptual development, basic design, detailed design
and implementation. The candidate will be accountable for robust
and timely delivery of project engineering deliverables in a
Position requires technical expertise in bioprocess equipment,
process piping design, control systems, or plant utility systems.
Experience with upstream and downstream biopharmaceutical facility
design, comprehensive knowledge of Good Engineering Practices (GEP)
and familiarity with ASME BPE, ASTM E2500 methodology is preferred.
Candidate will be a key technical interface between Manufacturing
and Facility clients, Engineering SMEs, and external engineering /
vendor resources during feasibility, conceptual design, detailed
design, specification, procurement, construction / fabrication, and
commissioning / verification of process and utility equipment for
cGMP production facilities.
All system improvements will be made in conjunction with
Manufacturing, Facilities & Engineering Manufacturing Sciences,
Quality Assurance, Validation, and Regulatory functions. Candidate
will be asked to develop and present practical solutions to a
variety of complex problems which require the regular use of
ingenuity and innovation.
Responsibilities Job Function and Description 30% Origination and
- Generates and develops technical project scope
- Documents all process/product, general user requirements and
generates basis of design packages
- Uses ingenuity and creative thinking to develop solutions
- Supports project managers in development of next-phase design
and / or implementation plans 30% Basic design, detailed design,
- Develops schematic and detailed design of systems including
construction documents (P&IDs, layouts, etc.)
- Specifies and sizes process, utility, and / or automation
- Plans, coordinates, and drives design, design review, and peer
- Manages external project engineering services effectively
- Leads design reviews and risk assessments to identify critical
aspects and verification methods Ensures development of FAT,
commissioning & verification plans 15% Implementation and close out
- Reviews and approves submittals
- Ensures successful FAT, SAT, commissioning, and verification
execution and approval
- Ensures completion and turnover of all project origination
design development, and ETOP documentation.
- Supports final robustness and fitness for use checks 25%
Standards, templates, and procedures
- Develop project engineering procedures, guidelines, and tools
to help achieve consistency
- Evaluates Shire's practices against best practices and
identifies program improvements
- Creates URS/FRS/DDS templates for use across sites
- Develops standardized commissioning and verification templates
Education and Experience Requirements Required education: Bachelors
degree in Chemical or Mechanical Engineering.
- Minimum 8 years experience in a cGMP Engineering
- Minimum 5+ years experience in equipment design and oversight
- Knowledge of Quality by Design (QbD), Quality Risk Management
(QRM) based on ICH Q8, Q9, and Q10 guidelines and experience with
implementing systems following the ASTM E2500 framework is
desirable. Key Skills, Abilities, and Competencies
- Must be able to work without appreciable direction to plan,
coordinate, and ensure completion of engineering team
- Effective verbal and written communication skills
- Excellent interpersonal, teamwork, and leadership skills
- Exercises considerable latitude in determining objectives and
approaches to assignments and plans, schedules and arranges own
activities in accomplishing milestone achievements
- Ability to multi task in a dynamic environment with changing
- Proficiency with Microsoft Products; ability to learn
additional software applications as the need arises Complexity and
- Individual must be capable of performing assignments to develop
solutions to complex problems which require the regular use of
ingenuity and innovation and where analysis of situations or data
requires an in-depth evaluation of variable factors.
- Exercises judgment in selecting methods, techniques and
evaluation criteria for obtaining results.--
- Ensures solutions are consistent with organization objectives
and serves as a consultant to management and special external
spokesperson for the organization on major matters pertaining to
its policies, plans, and objectives.
- Contributes to the development of new concepts, techniques, and
standards. Considered expert in field within the organization.
- Errors in judgment or failure to achieve results would result
in the expenditure of large amounts of company resources.
- Assists management in training and coaching less experienced
project engineering staff Internal and External Contacts
- Individual will represent Project Engineering and to work
closely with Project Managers, Schedulers, Engineering SMEs,
Manufacturing, Facility, Supply Chain, and QC clients, Validation ,
Quality, Procurement, Engineering Documentation Control and
HS&E team members.
- The candidate must be able to integrate the Validation and
Quality department requirements into all project phases
- Networks with key contacts outside own area of expertise as
well as senior internal contacts within area of expertise.
- Manages external project engineering service providers Check
out where you could be
working if you apply. Job Seekers: Protect yourself against
identity theft Please be aware there are instances of identity
thieves posting Takeda-branded jobs and posing as employees to
steal personal information. They visit job-related websites and
invite candidates to online chats. During the chat, they press job
seekers to provide bank account information and Social Security
numbers. Copyright 1995-2019 Takeda Pharmaceutical Company Limited.
All rights reserved.
Keywords: Takeda Pharmaceuticals International GmbH, Huntsville , Senior Project Engineer II - Process, Engineering , Lexington, Alabama
Didn't find what you're looking for? Search again!