Data Center Commissioning Senior Project Manager
Commissioning Agents Inc. job in Ashburn, VA
Your responsibilities as a Data Center Cx PM will include: Working with project teams at client sites to inspect, test, and troubleshoot data center/ building commissioning facilities and/ or equipment. This person is responsible for identifying and coordinating activities for commissioning and reporting. The Project Manager will be the POC with client (data center/ building commissioning companies) personnel and the Regional Manager. The Project Manager will execute the work as well as oversee it. Electrical and/or Mechanical commissioning experience is required.
Requirements include:
Position Requirements:
BS in an electrical, mechanical, engineering field or equivalent experience
12+ years or more of experience in commissioning and qualification in the Data Center industry, Leading large (minimum of 4 megawatts) projects/facilities. Comfort in the Construction industry (managing vendors, clients, subcontractors) is a plus.
Experience with commissioning plans/test scripts, schedules, budgets, change orders and summary reports is desired.
Experience managing multi-disciplinary teams with full commissioning responsibility is desired.
Other Requirements:
Excellent oral and written communication skills in English
Able to travel domestically and internationally as required
Able to work (paid) overtime
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are You Ready?
Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
CAI Operations DCx Managers will be exposed to cutting edge technologies in the Hyperscale and other spaces. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing data technologies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
#LI-MV1 #MISSIONCRITICAL
$128,300 - $150,800 a year
Average salary range, not including benefits or compensatory time and possible discretionary bonuses.
CAI Benefits:
* Comprehensive Health Insurance coverage
* 24 days of Paid Time Off
* ESOP/401K - 15% Company Contribution (US Only)
* Company paid Life Insurance
* Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Senior Validation Engineer
Commissioning Agents Inc. job in Charlottesville, VA
Are You Ready? CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For mission-critical and regulated industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.
Our approach is simple because our Purpose informs everything we do:
We exist to be the trusted solution for our clients as they strive to build a better working world and improve the human experience.
Our Foundational Principles:
* We act with integrity
* We serve each other
* We serve society
* We work for our future
At CAI, we believe in a relentless dedication to excellence, pushing boundaries and surpassing expectations. From the beginning, we've challenged ourselves to do what others wouldn't. Not just setting industry standards, but redefining them entirely. We are bold in our thinking and creative in our approach. We operate at the intersection of wisdom and technology and thrive when they come together with humanity.
For us, operational readiness isn't simply a goal-it's a way of life. Tomorrow demands to be at the forefront of today. We get there through tireless effort, precision, efficiency, and an unwavering belief that there is always room for advancement. We're not interested in how it used to be done. We're obsessed with how it will be done.
Key Responsibilities
CQV Execution & Safety
* Perform Commissioning, Qualification, and Validation (CQV) activities with a strong focus on safety
* Deliver C&Q activities in alignment with project schedules
* Track and report progress of CQV efforts
Documentation & Compliance
* Support the generation and review of C&Q procedures for client projects
* Review and revise qualification-related documents, including SOPs, master plans, and execution plans
* Assist with CQV review and qualification of equipment design
Project Planning & Coordination
* Support planning of commissioning spares and consumables
* Allocate project resources for efficient execution
* Coordinate support and logistics during CQV execution
Testing & Vendor Management
* Support execution of design reviews, equipment shakedown, commissioning, FATs, IQ, OQ, and PQ activities
* Coordinate with project contractors and equipment vendors to execute required testing
Qualifications and Experience
* Bachelor's degree (BS/BA) in Engineering, Chemistry, or Life Sciences (relevant experience can substitute for education)
* 3+ years of related experience in the Pharmaceutical/Life Sciences industry
* Essential experience in a GMP (Good Manufacturing Practice) environment
* Outstanding oral and written communication skills
* Strong problem-solving abilities
* Customer-focused mindset
* Willingness and flexibility to travel throughout the U.S. and potentially internationally
Critical Competencies
Influence Strategy
* Evaluates and pursues opportunities based on organizational strategy
* Identifies innovative solutions with strategic impact
* Anticipates emerging customer and market needs
Satisfy the Customer
* Understands and anticipates client needs
* Develops solutions that exceed expectations
* Actively follows up to ensure satisfaction and loyalty
Plan for Success
* Aligns business strategies with actionable plans
* Allocates resources effectively
* Anticipates risks and builds contingency plans
Pursue Execution
* Prioritizes initiatives to ensure goal achievement
* Holds self and team accountable
* Proactively removes obstacles
Tailor Communication
* Communicates clearly, concisely, and professionally
* Adjusts messaging to suit audience
* Explains technical concepts across all levels
Build Partnerships
* Builds strong networks across teams and disciplines
* Promotes collaboration and removes silos
* Involves stakeholders in decision-making
Influence Others
* Builds support through sound reasoning
* Gains buy-in from decision makers
* Encourages innovation and better outcomes
Develop Self and Others
* Continuously develops relationship and leadership skills
* Acts with integrity and models company values
* Seeks out breakthrough opportunities
#LI-MV1
$87,100 - $94,600 a year
Average base salary range - not including benefits, and potential overtime and/or Cost of Living Adjustment.
We are an equal opportunity employer; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Plasma Center Technician- OPEN AVAILABILITY NEEDED
Houston, TX job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - TX - Houston - Richmond Ave
U.S. Starting Hourly Wage:
$16.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - TX - Houston - Richmond AveWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
Auto-ApplyHouston North TX Plasma Care Technician
Houston, TX job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - TX - Houston - North
U.S. Starting Hourly Wage:
$16.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - TX - Houston - NorthWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
Auto-ApplySenior Plasma Center Technician - Phlebotomy PAID TRAINING
Kansas City, MO job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
Phlebotomist
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will greet donors as they enter and exit the donor floor.
· You will perform venipuncture of donors and programming of plasmapheresis machine.
· You will monitor donors during the donation process and manage donor reactions.
· You will perform all tasks required for the setup, verification, operation, and troubleshooting of plasmapheresis equipment within scope of training.
· You will install, prime, and disconnect disposable sets on the plasmapheresis machines
· You will stock supplies, break down empty cartons and assist with proper disposal.
· You will take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
· You will perform finger sticks, test sample, and record other donor measures to include hematocrit, total protein, and weight.
· You will enter donor information into the Donor Information System (DIS).
· You will coordinate donors to donor floor and compensate donors using the Debit Card system.
· You will support the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes through use of company approved procedures including 5S, Value Stream Mapping and Kaizen.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MO - Kansas City - Ambassador Dr
U.S. Starting Hourly Wage:
$17.00
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MO - Kansas City - Ambassador DrWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
No
Auto-ApplyDirector, Global Strategy
Remote or Gurnee, IL job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About BioLife Plasma Services
BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Ltd., is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 245+ state-of-the-art plasma donation centers across the United States. Our employees are committed to improving the quality of life for patients and ensuring that the donation process is safe, easy, and rewarding for donors who want to make a difference.
When you work at BioLife, you'll feel good knowing what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
This position is currently classified as “hybrid” and is based out of Bannockburn, IL in accordance with Takeda's Hybrid and Remote Work policy.
OBJECTIVES/PURPOSE
This role focuses on executing the global strategy for BioLife Plasma that aligns with PDT (Plasma Derived Therapies) and Takeda's objectives to drive business results over the mid to long term for a sustainable outcome. Responsibilities include leading the execution of key strategies that impact the growth and innovation of Global BioLife while ensuring cohesive and effective systems & processes exist end-to-end to drive efficiencies across the business.
ACCOUNTABILITIES
Develop and implement business strategies across functions, processes, or operational plans.
Lead cross-functional teams in strategic planning activities, develop milestones and objectives.
Communicate with leadership and conduct briefings and meetings with top management and external stakeholders.
Prioritize and track strategic business impact across new developments or initiatives.
Identify growth opportunities and business model innovations.
Evaluate and financially model potential strategic opportunities.
Monitor short, medium, and long-term business trends through market intelligence that impact strategy.
DIMENSIONS AND ASPECTS
Technical/ Functional (Line) Expertise
Provide strategic direction to optimize end-to-end global business processes, ensuring alignment with organizational goals.
Demonstrate deep expertise in operational planning, systems integration, and financial modeling for growth and efficiency.
Decision-making and Autonomy
Make high-impact, long-term operational and financial decisions, balancing risks and opportunities aligned with business priorities.
Operate with autonomy to lead cross-functional initiatives, ensuring timely delivery and alignment with organizational strategy.
Leadership
Inspire and lead by fostering a culture of innovation, continuous improvement, and accountability.
Act as a strategic partner to senior leadership, delivering insights to shape business outcomes.
Interaction
Collaborate with global stakeholders across various functions to ensure alignment on strategic initiatives and objectives across the value chain.
Serve as a key liaison between executive leadership and operational teams, ensuring effective communication of priorities.
Innovation
Drive continuous improvement by identifying emerging trends, technologies, and business models to sustain competitive advantage.
Champion a culture that encourages innovation and the adoption of transformational strategies.
Complexity
Navigate challenges within a dynamic global business environment, balancing diverse cultural and regulatory considerations.
Manage a mix of established and emerging business units, addressing complexities across geographies and product lifecycles.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
:
Education
Required: Bachelor's degree in Business Administration, Finance, Healthcare Management, or related field.
Preferred:
Advanced degree (MBA, MHA, or equivalent) from a recognized institution.
Extensive experience (10+ years) in strategic operations, business planning, or leadership in a global setting.
Specialized certifications relevant to operational excellence, financial modeling, or healthcare strategy (e.g., PMP, Lean Six Sigma).
Skills
Strategic Thinking and Execution
Strong ability to analyze complex business challenges and translate them into actionable strategies with durable results.
Expertise in project management, resource prioritization, and leading cross-functional global teams.
Technical Expertise
Ability to lead and implement strategic planning exercises across functions and businesses
Proficiency in financial modeling, data analytics, and systems integration to optimize operational efficiency.
Knowledge of healthcare industry regulations and market dynamics, particularly within plasma-derived therapies or global supply chains.
Communication and Influence
Exceptional verbal, written, and presentation communication skills; capable of presenting complex information clearly to all stakeholders.
Strong influencing skills to gain alignment and drive decision-making among cross-functional teams and executive leadership.
Behavioral Competencies
Leadership and Collaboration
Demonstrates a growth mindset and promotes a culture of inclusion and innovation.
Fosters strong partnerships across global teams by building trust and leveraging diverse perspectives.
Problem-Solving and Adaptability
Resilient in dynamic, fast-paced environments; adapts quickly to changing priorities while maintaining focus on objectives.
Applies critical thinking and creativity to overcome barriers and deliver impactful solutions.
Accountability and Integrity
Operates with a strong sense of ownership, ensuring accountability for results and adherence to ethical standards.
Embodies Takeda's values, acting as a role model for transparency and corporate responsibility.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Bannockburn, IL
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBannockburn, ILUSA - IL - ChicagoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
Yes
Auto-ApplyQuality Lead Technician
Colorado Springs, CO job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
ACCOUNTABILITIES
Performs duties associated with Quality (including but not limited to): (50%)
Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations.
Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%)
Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
Maintain certification and perform all required duties of Lead Technician. (10%)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
Effective communication, organizational, and technical/problem-solving skills.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Good verbal communication and customer service skills.
Ability to multi-task and work as a team player.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Associate or Bachelor's degree preferred
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CO - Colorado Springs - Sou
U.S. Hourly Wage Range:
$21.00 - $28.88
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - CO - Colorado Springs - SouWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyMedical Support Specialist/ Intake Nurse- Bilingual Spanish/English (EMT-P)
Dallas, TX job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a Medical Support Specialist (Plasma Center Nurse) to support plasma center operations.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will determine donor eligibility to donate plasma, management of donor adverse events, review of laboratory test results, and donor notification of unsuitable test results. The Medical Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager (or Assistant Manager as applicable) for operational guidance and under the management of the Center Physician for medical issues. The Medical Support Specialist will be familiar with regulations of the plasma collection industry or a manufacturing environment. The Medical Support Specialist follows guidance provided by BioLife Medical Affairs and provides center level support of environmental, health and safety (EHS).
How you will contribute
You will determine donor eligibility; to include, proper management of informed consent, AIDS education and confidential self-exclusion, medical history interview and acceptance requirements, physical examination, blood testing, and reviewing Serological Protein Electrophoresis (SPE).
You will evaluate donor reaction(s), which occurs at the facility as outlined in the SOPs. Follow applicable SOPs for medical emergencies including the development of Center Physician's standing orders and donor transport to emergency care facilities.
You will refer to the Center Physician or Medical Affairs (as applicable) when in need of providing unacceptable findings to donors, or guidance concerning medical or technical issues, including donor safety and eligibility.
You will support the Hepatitis B and Seasonal Flu vaccination programs for employees as applicable.
You will manage employee incidents and determine whether further evaluation is required by occupational health/ER. Refer to EHS guidance regarding employee incidents.
You can be a Pandemic Coordinator when authorized by EHS and support investigations associated with pandemic threats within the local community as indicated by EHS or Medical Affairs.
What you bring to Takeda:
High school diploma or equivalent to including graduate equivalent of a recognized educational nursing program with state requirements
Currently licensed or certified in the state where responsibilities will be assigned: EMT-Paramedic
Current Cardiopulmonary Resuscitation (CPR) and AED certification
Fulfill state requirements (in state of licensure) for basic IV therapy
Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist
Two years in a clinical or hospital setting
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include medical/dental, paid time off and retirement benefits, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to bring Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - TX - Dallas - Belt
U.S. Hourly Wage Range:
$23.85 - $32.79
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - TX - Dallas - BeltWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyDocumentation (QC) Specialist
New Brunswick, NJ job
Job title: Documentation (QC) Specialist
Duration: 12 months
Pay Rate: $54.44 - $59.44/ hr on W2
50% onsite required
Work Schedule: Mon-Fri (normal business hours)
Job Description:
Management of commercial specifications and methods (internal release, stability, regulatory and compendial), and supporting documents for all client drug products, drug substances, intermediates, starting materials, excipients, reagents and packaging components, including quality assessment of change proposals to create new, or revise commercial specifications and methods.
Primary responsibility of candidate will be to perform content review of change controls including global testing standards and test method documents.
Candidate must have basic knowledge of document management, change control and strong familiarity with QC type documents (methods and specifications for product testing).
Responsibilities:
Manage commercial specifications and methods to ensure clear, correct, concise, consistent, and compliant documentation.
Review and execute change proposals for GTS documents.
Perform quality approval of GTS documents.
Maintain the GTS system, including managing notification templates and obsolescing documents that are no longer in use.
Qualifications:
Minimum of a bachelors degree is required
Minimum 4 years experience in the pharmaceutical industry or related field.
Cross-functional experience in two or more areas (e.g. research, analytical/QC, QA, stability, supply chain, manufacturing, CMC, IT, etc.).
Knowledge of specifications/methods, compendia, cGMP requirements, and regulatory expectations.
Document management experience in a systems-related environment.
Change management experience.
Experience with SAP or Lab Information Management systems.
Capabilities:
Ability to set priorities and deliver results independently.
Customer and partner focus, including the ability to listen to and incorporate feedback (as appropriate)from key stakeholders.
Ability to influence, initiate, and manage change.
Organization awareness and ability to work well cross-functionally with R&D, Regulatory, IT, etc.
Detail-oriented with a quality mindset.
Strong verbal and written communication skills.
MS Office experience.
Excellent meeting facilitation and project management skills.
Director R&D
Minneapolis, MN job
We are seeking a visionary and execution-focused Director of R&D to lead the development of a novel medical device platform from the ground up. This is a high-impact, high-visibility role backed by executive leadership at a $10B global medical device company. Unlike a typical director position, this role involves building the R&D site, assembling a world-class team, and defining the product roadmap for the next decade.
The successful candidate will be instrumental in shaping the future of the company's innovation pipeline and will have a clear path to long-term leadership within the organization.
Key Responsibilities:
Architect and lead the development of a first-of-its-kind medical device platform.
Build and scale the R&D site, including hiring and mentoring top engineering and scientific talent.
Define and execute a 10-year product development roadmap in alignment with strategic business goals.
Oversee all phases of product development: concept, feasibility, design, verification/validation, and transfer to manufacturing.
Ensure compliance with global regulatory standards (FDA, ISO 13485, EU MDR).
Collaborate closely with Regulatory, Quality, Clinical, and Commercial teams to support submissions and market launches.
Drive innovation through technology scouting, IP strategy, and external partnerships.
Manage budgets, timelines, and resource allocation across multiple development programs.
Qualifications:
Bachelor's degree in Engineering, Biomedical Sciences, or related field (Master's or PhD preferred).
10+ years of experience in medical device R&D, with at least 5 years in a leadership role.
Proven success in launching Class II or III devices and scaling R&D operations.
Deep understanding of design controls, risk management (ISO 14971), and product lifecycle management.
Experience with IQ/OQ/PQ, DHF, and regulatory submissions (510(k), PMA, CE Mark).
Strong leadership, strategic thinking, and cross-functional collaboration skills.
Preferred Experience:
Experience building or scaling R&D teams or facilities.
Familiarity with Lean Product Development or Agile methodologies.
Prior involvement in strategic planning, M&A, or corporate innovation initiatives
Why This Role Is Unique:
Executive Sponsorship: Direct support from senior leadership ensures resources and visibility.
Strategic Impact: Define the future of a product line with global reach and clinical significance.
Career Trajectory: For the right developmental leader, success in this role will solidify a long-term leadership path within a $10B medical device giant.
Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)
Remote or Morristown, NJ job
Job Title: Director, US Regulatory Affairs - Advertising and Promotion (Hybrid)
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
As the Director, US Regulatory Affairs - Advertising and Promotion, you'll partner with other key functional teams to ensure materials are consistent with US regulations, company policy and industry guidelines. You'll be asked to solve problems creatively and strategically, and introduce innovative concepts to more effectively manage ad/promo projects. This is a subject matter expert role wiht no direct reports, though there will be mentoring, training and team leadership opportunities.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Understanding of the U.S. pharmaceutical marketplace and familiarity with medical terminology.
Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision-making process.
Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports.
In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams, and functions as the therapeutic product expert.
Continually monitors the regulatory environment, interprets new regulations, guidance, and enforcement activities/trends and evaluates the impact on external environments and the business.
Develops and implements regulatory strategies for marketed products within their product area and mentor and develop others in executing strategy.
Establishes and develops key internal relationships with therapeutic product leaders to foster open communication and teamwork.
Assures alignment and consistency in policy application within and across therapeutic products; takes into account the totality of product-related and company activities.
Assists in ensuring product support relationships with FDA are established and maintained.
Provides input into the global organization for labeling strategies of marketed drugs.
Demonstrates significant autonomy in carrying out assigned duties and responsibilities.
About You
Earned Bachelor's degree (required) from an accredited four-year college or university in a Life Sciences or other relevant discipline
8+ years of experience within pharmaceutical or medical device Regulatory Affairs, with 5+ years specifically within advertising & promotion functions
Leadership, mentoring and/or training experience within regulatory or ad/promo is highly preferred
Extensive knowledge and understanding of complex medical and scientific subject matter, including statistical data.
Can build networks to obtain cooperation without relying on authority, including participating in cross-functional groups (medical, legal, regulatory, etc.) to lead toward decisions.
Ability to generate innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities.
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans.
Able to establish priorities and timelines to effectively self-manage workload. Is able to multitask exceptionally well.
Deals with people in an honest and forthright manner representing information and data accurately.
Why Choose Us
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SA
#LI-SA
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Auto-ApplyAdvanced Plasma Technician
Colorado Springs, CO job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Responsible for all job duties associated with the screening, processing, and sample collection for new and repeat donors, as well as providing training to staff. Fully trained in all Medical History, Phlebotomy, and Sample Processing job skills.
All listed duties must comply with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.
ACCOUNTABILITIES
Committed to meet customer service expectations (10%)
Greet donors as they enter and exit the donor floor.
Answer phones within reasonable timeframe.
Maintain orderly filing system, purging records as needed.
Perform all core and elective duties in the area of Phlebotomy (including, but not limited to): (40%)
Perform venipuncture of donors and programming of plasmapheresis machine.
Monitor donors during donation process and manage donor reactions.
Troubleshoot venipuncture issues and respond to plasmapheresis machine alarms.
Perform all core and elective duties in the area of Medical History (including, but not limited to): (25%)
Take and record donor pulse, blood pressure, and temperature measures and monitor electronic donor questionnaire system.
Perform finger stick, test sample, and record other donor measures to include hematocrit, total protein and weight.
Perform all core and elective duties in the area of Sample Processing (including, but not limited to): (15%)
Prepare units for frozen storage.
Collect and store samples from plasma units for testing.
Organize plasma boxes/documents for scheduled shipments and assist in loading shipments.
Provide training assistance in support of center management and supervisory team (10%)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Good verbal communication and customer service skills.
Demonstrated technical competence
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Ability to multi-task and work as a team player.
Attention to detail and ability to work independently
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 32 pounds, and occasional lifting up to 50 pounds.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Experience in a laboratory, hospital, or other regulated environment is a plus
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - CO - Colorado Springs - Sou
U.S. Hourly Wage Range:
$20.00 - $25.41
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - CO - Colorado Springs - SouWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyDirector, Global Marketing - Pompe Disease
Cambridge, MA job
Job Title: Director, Global Marketing - Pompe Disease
About the Job
Reporting to the Global Brand Lead, Pompe, this position has primary responsibility for developing and executing global marketing strategies in support of Nexviazyme, a novel treatment for Pompe Disease.
We are an innovative global healthcare company, committed to transforming the lives of people with immune challenges, rare diseases and blood disorders, cancers, and neurological disorders. From R&D to sales, our talented teams work together, revolutionizing treatment, continually improving products, understanding unmet needs, and connecting communities. We chase the miracles of science every single day, pursuing progress to make a real impact on millions of patients around the world.
Main Responsibilities:
Lead the annual Integrated Brand Planning (IBP) process with global and country stakeholders.
Partner with country teams to co-create innovative omni-channel patient identification programs that shorten the diagnostic journey.
Support Nexviazyme's global launches by ensuring affiliate readiness through training, resources, and KPI alignment, drive flawless execution.
Strengthen competitive readiness and brand differentiation by creating impactful branded assets, managing budgets, and leading agencies.
Collaborate with selected markets via the Global Brand Team (GBT) and Monthly Performance Reviews (MPRs) to co-develop strategies, ensure pull-through, meet local needs and optimize performance.
Own global commercial meetings including Advisory Boards, Expert Forums, and major congress activities to strengthen stakeholder engagement and visibility.
Travel: 20%
About You
6+ years pharmaceutical or biopharmaceutical marketing experience (global or affiliate)
BA/BSc or equivalent required; advanced degree preferred (MBA, MSc,
Strong background in digital and omnichannel marketing preferred.
Knowledge of compliance and regulatory considerations in pharma/biopharma marketing.
Proven ability to work in a matrix, global environment, balancing global-to-local needs.
Strong communication and presentation skills, with ability to influence senior stakeholders.
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.
#GD-SG
#LI-GZ
#LI-Onsite
#vhd
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
Auto-Apply
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Responsible for all job duties associated with the screening, processing, and sample collection for new and repeat donors, as well as center leadership and training. Fully trained in all Medical History, Phlebotomy, and Sample Processing job skills. Position will provide oversight of operational flow, assist in training new and existing employees, and provide leadership to staff.
All listed duties must comply with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.
ACCOUNTABILITIES
Committed to meet customer service expectations (5%)
Greet donors as they enter and exit the donor floor.
Answer phones within reasonable timeframe.
Maintain orderly filing system, purging records as needed.
Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (60%)
Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (25%)
Perform all non-core area tasks, and those limited to Lead Technician and above (including, not limited to): (10%)
Respond and analyze HB detect alarms associated with Aurora machines and/or RBC spills associated with the PCS2 machines.
Perform change of lot number for soft goods.
Perform quarterly and annual tube sealer maintenance
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Good verbal communication and customer service skills.
Demonstrated technical competence
Requires demonstrated leadership and technical expertise, including full certification in Medical History, Phlebotomy, and Sample Processing.
Internal promotion requiring a minimum of one-year experience with BioLife, deviation from guideline may occur based on business needs.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Effective coaching and counseling skills.
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Ability to multi-task and work as a team player.
Attention to detail and ability to work independently
Effective coaching and counseling skills.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 32 pounds, and occasional lifting up to 50 pounds.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
Requires frequent lifting up to 32 pounds, and occasional lifting up to 50 pounds.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Experience in a laboratory, hospital, or other regulated environment is a plus
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - TX - Spring
U.S. Hourly Wage Range:
$19.00 - $26.13
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - TX - SpringWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyQuality Lead Technician
Fayetteville, NC job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About BioLife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd.
OBJECTIVES/PURPOSE
Monitors designated systems and activities, according to tasks trained and assigned, to ensure that source plasma manufacturing is performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is able to perform all technical tasks required within the work areas and will work in these areas as a Lead Technician (or Center Supervisor by exception) when not acting as the Quality Lead Technician.
All below listed responsibilities must be completed in compliance with federal, state, local and company-specific regulations related to quality of product, employee and donor safety, and to the proper performance of day-to-day activities. Employees must also maintain complete and accurate records, in accordance with cGMP.
ACCOUNTABILITIES
Performs duties associated with Quality (including but not limited to): (50%)
Reviews operational records in association with tasks trained and assigned to ensure they are complete, accurate and compliant with cGMP requirements.
Tracks deviations in operating procedures and policies through established mechanisms. Reports error, deficiencies, discrepancies and observations to center management and Quality Management Representative (QMR).
Conducts monthly quality assurance audits for critical control points and key elements for the systems related to donor suitability, source plasma collection, sample collection, plasma storage, product release, quality assurance, and employee training program.
Ensures SOP's are current and that staff perform routine tasks according to SOP through direct observation.
In the absence of a QMR, works in collaboration with the management team to prepare for and host (if needed) internal auditors and external inspectors. Assists center management teams to ensure timely closure of observations.
Maintain qualifications and perform all duties (core and elective) for Medical History, Phlebotomy, and Sample Processing areas. Train new and existing staff on donor center procedures through demonstration, instruction, observation, and feedback. (30%)
Provide leadership and training assistance in support of center management and supervisory team, including oversight of operational flow. (10%)
Maintain certification and perform all required duties of Lead Technician. (10%)
DIMENSIONS AND ASPECTS
Technical/Functional (Line) Expertise
A minimum of one year of relevant work experience, preferably in a regulated industry, or an equivalent combination of education and experience.
Certification in all three primary operational areas of the plasma center (Medical Historian, Phlebotomy, and Processing Technician).
Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA-regulated environment.
Effective communication, organizational, and technical/problem-solving skills.
Supports the center management team in identifying operational opportunities for continuous improvement, initiating changes to center processes as needed, through use of company approved procedures (including but not limited to 5S, Value Stream Mapping and Kaizen).
Maintain general cleanliness of work area and assist other work areas as needed to ensure a clean and professional environment.
Ability to read and follow Standard Operating Procedures (SOPs) and to maintain complete and accurate records.
Leadership
Integrity
Fairness
Honesty
Perseverance
Putting the patient at the center
Building trust with society
Reinforcing our reputation
Developing the business
Decision-making and Autonomy
Refers to Center Manager for guidance on complex, medium-impact or above decisions (internal)
Refers to management team for escalated donor/employee concerns (internal)
Interaction
Responsible for providing exceptional customer service to donors (external) and fellow employees (internal)
Attend staff meetings and other team meetings as required.
Good verbal communication and customer service skills.
Ability to multi-task and work as a team player.
Innovation
Coordinates will all other center roles to effectively problem solve, ensure safety of staff and donors, and provide an exceptional customer experience.
Complexity
Production environment requiring the ability to walk and stand for the entire work shift.
Requires frequent leaning, bending, stooping, crouching, and reaching above the shoulders and below the knee.
Requires frequent lifting up to 26 lbs. and occasional lifting of materials 32 lbs. - 50 lbs.
Must have fine motor coordination, depth perception, and ability to hear equipment sounds from a distance.
Due to potential exposure to blood borne pathogens (risk level 1), 90% of work tasks require pro-longed glove wear
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
Essential: High School Diploma or equivalent required
Desired: Associate or Bachelor's degree preferred
ADDITIONAL INFORMATION
FLSA Classification (US) - Non-Exempt
Other duties and responsibilities as assigned.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - NC - Fayetteville - Morgan
U.S. Hourly Wage Range:
$20.00 - $27.50
The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - NC - Fayetteville - MorganWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
No
Auto-ApplyData Center Services Mechanical Commissioning Engineer Staff II
Commissioning Agents Inc. job in Ashburn, VA
CAI seeks Mechanical Commissioning Engineers, Minimum two years' experience in Data Center Commissioning to support development and execution of all mechanical aspects of commissioning projects.
This position supports development and execution of all mechanical aspects of assigned commissioning projects from initial engagement, design reviews, checklists, safety support, script development, vendor coordination, testing and report development through turn over to the client. The Mechanical Commissioning Engineer will support the development of the mechanical test schedule, finalize mechanical test procedures, review project submittals for consistency with the design intent, basis of design and the owner's project requirements, and maintain project cadence for the mechanical systems testing and associated Building Automation Systems. The Mechanical Commissioning Engineer is to support the planning and execution of commissioning for the mechanical infrastructure of the mission critical facility. They will be expected to execute against the project schedule through the coordination of contractors and/or vendors to complete the desired mechanical systems testing.
CAI DC Mechanical Commissioning Engineer will be exposed to cutting edge technologies in the Hyperscale and other spaces. You will have an opportunity to work with recognized subject matter experts allowing YOU to be a key player in bringing data technologies to market. As part of our company culture, we invest in YOUR future, and commit to hands on certifications as well as professional training. Our collaborative culture ensures that our customers benefit from exemplary work across our entire range of professional services.
Responsibilities:
Support and contribute to all aspects of safety for all mechanical tests.
Support complete commissioning and performance acceptance testing of the mechanical infrastructure systems.
Development of all mechanical test procedures, MOPS, SOO's and checklists.
QA/QC of all mechanical test procedures.
Provide input and insight to the overall commissioning plan.
Develop reports for the mechanical testing and contribute to a daily report to the Commissioning Project Manager.
Attend and be an active participant of customer equipment Factory Witness Test
Assist with vendor coordination and management.
Perform equipment inspection to ensure build adherence to vendor submittal.
Provide test documentation that equipment is delivered, installed, and tested correctly and set to function properly for the customer.
Support and perform design specification review, manufacturer submittals, one line drawing sets, and project schedule documentation.
QA/QC of mechanical equipment installation\startup
Execute test scripts to confirm equipment and system operation to design specification.
Ensure safe work practices are followed by the commissioning team and customer site.
Engage with customers and vendors to ensure positive experience, goals achievement, and schedule adherence.
Provide daily status reports for mechanical commissioning team status.
Conduct facility walk downs, turnover, and punch list reviews.
General understanding of LEED specifications and requirements.
Look for new opportunities for CAI to provide service and value to customer.
Duties may be increased as experience and skill allow.
Requirements include:
Position Requirements:
Bachelor's degree or equivalent experience
Minimum of 2 years Data Center Commissioning experience.
Knowledge of OSHA safety requirements.
Good written and verbal communication skills.
Ability to read and interpret mechanical drawings, P&ID's and specifications.
Knowledge of mission critical design concepts.
Knowledge of various Building Automation/Monitoring Systems (BAS/BMS), Air Handlers, Humidifiers, Variable Refrigerant Flow, Computer Room Air Conditioners/Handlers (CRAC/CRAH), Evaporators, Adiabatic Coolers, Pressure/Temperature/Humidity sensors & Flowmeters.
Knowledge of basic thermodynamics and heat transfer and fluid flow.
Knowledge of the Test, Adjust and Balance (TAB) process.
Knowledge of mechanical trend analysis.
Strong experience with Word, Excel and PowerPoint. Can effectively create final products in all three programs.
Work under construction site conditions
Other Requirements:
Excellent oral and written English is required
Extensive travel may be required (75%)
Candidates must have a Passport or the ability to immediately get a Passport
Able to work in the US without sponsorship now or any time in the future.
About CAI
CAI is a 100% employee-owned company established in 1996, that has grown year over year to more than 800 people worldwide. We provide commissioning, qualification, validation, start-up, project management and consulting services related to operational readiness to FDA regulated and other mission critical industries.
Are You Ready?
Our approach is simple; we put the client's interests first, we do not stop until it is right, and we will do whatever it takes to get there.
As owners of CAI, we are committed to living our Foundational Principles, both professionally and personally:
We act with integrity
We serve each other
We serve society
We work for our future
With employee ownership, one person's success is everyone's success; we work diligently to accomplish team goals. We place Team Before Self, demonstrate Respect for Others, and possess a can-do attitude. That is how we have grown exponentially.
Benefits
Our full-time positions offer competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per year, health insurance at extremely low cost to employee, financial support for both internal and external professional education as well as 70% long term disability paid for by the company.
#LI-MV1 #MISSIONCRITICAL
$72,800 - $85,500 a year
Average salary range, not including benefits or compensatory time and possible discretionary bonuses.
CAI Benefits:
* Comprehensive Health Insurance coverage
* 24 days of Paid Time Off
* ESOP/401K - 15% Company Contribution (US Only)
* Company paid Life Insurance
* Company paid Long Term Disability
We are an equal opportunity employer; we are proud to employ veterans and promote a diverse culture in our workplace. Diversity is a strength for our global company. We pledge that CAI will be operated in a way that is fair and equitable to all - our employees, our customers, and the broader society.
This job description is not all inclusive and you may be asked to do other duties. CAI will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the FCO.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.
Validation Engineer II
Indianapolis, IN job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a talented CQV Engineer II to join our team at our office located in _____________.
In this role, you will perform cGMP compliance-based services (commissioning, qualification, validation, consulting, etc.) as developed and defined in project agreements with IPS clients. You will also follow IPS and client standards and requirements, overall good industry practices for C/Q/V services, and regulatory requirements. You may also perform standalone commissioning services for non-FDA-regulated clients.
Additional Responsibilities
Write C/Q/V documents following established standards and templates, including but not limited to the following:
Commissioning Forms
C/Q/V Protocols and Summary Reports
Standard Operating Procedures
Impact Assessments
Specifications (URS/FRS/DDS)
FATS/SATs
Perform field/site activities including, but not limited to, the following:
Attend and witness FATs and SATs as a representative of IPS clients.
Execution of commissioning forms and witnessing of vendor start-up and testing.
Execution of C/Q/V protocols.
Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
Assist in deviation investigation and resolution of problems and issues encountered during field execution activities.
Work with the Project Delivery department or CM for start-up and vendor testing. Witness and troubleshoot as required.
Primary responsibilities include C/Q/V of equipment and systems, including CSV and automation, supporting pharmaceutical, biotech, and medical device industries.
Read, understand, and utilize the IPS Best Practices and SOPs for the delivery of compliance services
Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS project leaders, project managers, or management, of project status and issues, as requested.
Come join our dynamic team that creates world-class designs for our clients, and propel your career to new horizons!
Qualifications & Requirements
Bachelor of Science in Engineering.
2+ years of relevant work experience.
This is an entry-level position.
Experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
Preferred Qualifications
Experience in writing and execution of PFC, FC, IQ, OQ, and PQ forms/protocols for GMP Utilities, Equipment, Systems, and Software.
General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA.
Context & Safety
This position will have up to 100% travel to the site, or as required by the assigned project.
You may be assigned to a client site for an extended period.
Overnight travel or staying in the city of the client's location is possible depending on the assignment.
Travel will be per the IPS Travel Policy, client-specific travel policy, or project-specific travel plan.
You may visit active construction sites and will be required to take site safety training and adhere to site safety rules.
This position is a safety-sensitive position.
The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Director, Global Strategy
Remote or Bridgeview, IL job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
About BioLife Plasma Services
BioLife Plasma Services, a subsidiary of Takeda Pharmaceutical Company Ltd., is an industry leader in the collection of high-quality plasma that is processed into life-saving plasma-based therapies. Some diseases can only be treated with medicines made with plasma. Since plasma can't be made synthetically, many people rely on plasma donors to live healthier, happier lives. BioLife operates 245+ state-of-the-art plasma donation centers across the United States. Our employees are committed to improving the quality of life for patients and ensuring that the donation process is safe, easy, and rewarding for donors who want to make a difference.
When you work at BioLife, you'll feel good knowing what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we'll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.
This position is currently classified as “hybrid” and is based out of Bannockburn, IL in accordance with Takeda's Hybrid and Remote Work policy.
OBJECTIVES/PURPOSE
This role focuses on executing the global strategy for BioLife Plasma that aligns with PDT (Plasma Derived Therapies) and Takeda's objectives to drive business results over the mid to long term for a sustainable outcome. Responsibilities include leading the execution of key strategies that impact the growth and innovation of Global BioLife while ensuring cohesive and effective systems & processes exist end-to-end to drive efficiencies across the business.
ACCOUNTABILITIES
Develop and implement business strategies across functions, processes, or operational plans.
Lead cross-functional teams in strategic planning activities, develop milestones and objectives.
Communicate with leadership and conduct briefings and meetings with top management and external stakeholders.
Prioritize and track strategic business impact across new developments or initiatives.
Identify growth opportunities and business model innovations.
Evaluate and financially model potential strategic opportunities.
Monitor short, medium, and long-term business trends through market intelligence that impact strategy.
DIMENSIONS AND ASPECTS
Technical/ Functional (Line) Expertise
Provide strategic direction to optimize end-to-end global business processes, ensuring alignment with organizational goals.
Demonstrate deep expertise in operational planning, systems integration, and financial modeling for growth and efficiency.
Decision-making and Autonomy
Make high-impact, long-term operational and financial decisions, balancing risks and opportunities aligned with business priorities.
Operate with autonomy to lead cross-functional initiatives, ensuring timely delivery and alignment with organizational strategy.
Leadership
Inspire and lead by fostering a culture of innovation, continuous improvement, and accountability.
Act as a strategic partner to senior leadership, delivering insights to shape business outcomes.
Interaction
Collaborate with global stakeholders across various functions to ensure alignment on strategic initiatives and objectives across the value chain.
Serve as a key liaison between executive leadership and operational teams, ensuring effective communication of priorities.
Innovation
Drive continuous improvement by identifying emerging trends, technologies, and business models to sustain competitive advantage.
Champion a culture that encourages innovation and the adoption of transformational strategies.
Complexity
Navigate challenges within a dynamic global business environment, balancing diverse cultural and regulatory considerations.
Manage a mix of established and emerging business units, addressing complexities across geographies and product lifecycles.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
:
Education
Required: Bachelor's degree in Business Administration, Finance, Healthcare Management, or related field.
Preferred:
Advanced degree (MBA, MHA, or equivalent) from a recognized institution.
Extensive experience (10+ years) in strategic operations, business planning, or leadership in a global setting.
Specialized certifications relevant to operational excellence, financial modeling, or healthcare strategy (e.g., PMP, Lean Six Sigma).
Skills
Strategic Thinking and Execution
Strong ability to analyze complex business challenges and translate them into actionable strategies with durable results.
Expertise in project management, resource prioritization, and leading cross-functional global teams.
Technical Expertise
Ability to lead and implement strategic planning exercises across functions and businesses
Proficiency in financial modeling, data analytics, and systems integration to optimize operational efficiency.
Knowledge of healthcare industry regulations and market dynamics, particularly within plasma-derived therapies or global supply chains.
Communication and Influence
Exceptional verbal, written, and presentation communication skills; capable of presenting complex information clearly to all stakeholders.
Strong influencing skills to gain alignment and drive decision-making among cross-functional teams and executive leadership.
Behavioral Competencies
Leadership and Collaboration
Demonstrates a growth mindset and promotes a culture of inclusion and innovation.
Fosters strong partnerships across global teams by building trust and leveraging diverse perspectives.
Problem-Solving and Adaptability
Resilient in dynamic, fast-paced environments; adapts quickly to changing priorities while maintaining focus on objectives.
Applies critical thinking and creativity to overcome barriers and deliver impactful solutions.
Accountability and Integrity
Operates with a strong sense of ownership, ensuring accountability for results and adherence to ethical standards.
Embodies Takeda's values, acting as a role model for transparency and corporate responsibility.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
Bannockburn, IL
U.S. Base Salary Range:
$174,500.00 - $274,230.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsBannockburn, ILUSA - IL - ChicagoWorker TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Job Exempt
Yes
Auto-ApplyProject Manager (Utilities Construction)
Somerset, NJ job
At IPS, we are global leaders in developing innovative solutions for the consulting, architecture, engineering, project controls, procurement, construction management, and CQV of technically complex facilities, primarily in the life sciences industry. We are looking for a dedicated Project Manager to join our talented team at our office located in Somerset, New Jersey.
In this role, you will manage project coordination with Inside Plant (“IP”) Construction and Outage Planning, the engagement of various internal departments in the project, and communicate directly to ensure that project support needs are met by internal departments. You will also manage Project Engineering in the development of the Material Tracking Log (“MTL”), support all material procurement activities, and ensure that the MTL is maintained throughout the Project lifecycle.
Additional Responsibilities
Organizes weekly engineering meetings between Project Management, Project Engineering, Project Controls, Procurement, Licensing and Permitting, Corporate Properties, and the Architectural Engineering (“A&E”) firms.
Ensures the creation and distribution of weekly action item lists to project stakeholders.
Coordinates daily communication between the Project management team, Project Engineering, and the A&E firms.
Creation and management of the Project Scope Document, and participation in the procurement of all stakeholder signatures.
Creation and management of the Project Execution Plan and Risk Register, and participation in the stakeholder approval process.
Review Contractor submittals, including monthly reports, schedules, and cash flow documents.
Manage the following:
facilitation of design reviews by the Project Engineering Division, and ensuring that everything is signed by the appropriate parties
the development of monthly reports for the project and engaging all stakeholders in contributing to their individual sections
the facilitation of project detailed design by the A&E firm, and support the preparation, development, and review of technical specifications
the execution of the Quality Assurance and Control Plan
Project closeout activities, including lessons learned meetings, the submittal of As-Built drawings, documentation turnover, and the closeout of all permits and purchase orders.
Support site construction management in verifying that construction activities comply with design and specifications, and support the execution of the detailed commissioning and testing plan.
Support the documentation of all lessons learned activities in the Company database.
The salary range for this role is between $120,000 and $150,000 but actual salary offered is dependent on experience, skill set and education.
Qualifications & Requirements
15+ years of professional experience.
Bachelor's degree in a technical field: engineering, project management, construction management.
Professional credentialing is strongly encouraged (CCT or CCP, CST or CSP, EVP, CMIT or CCM, EIT).
PMP Certification.
High level of computer expertise in multiple industry-wide software products, such as:
MS Office Products
Scheduling software such as Primavera and MS Project
Client ERP systems such as JDE, QUAD, SAP, ARIBA, CONCUR
PPM Software: Prolog, Proliance, Prism G2, Procore, Cleopatra, Cora Systems
Context, Environment, & Safety
A safety-minded individual who complies with the IPS Mission Zero Safety policy.
Capable of working alone or as part of a team without a significant level of supervision.
The employee is frequently required to stand, walk, and sit for long periods of time with extended computer use.
Experience working in both a Home Office and a Field environment.
Travel to client sites as needed.
This position is a safety-sensitive position. The employee is designated for field work and attends activities at client sites where they work in construction, process, packaging, manufacturing, research, or other "non-administrative" areas.
All interviews are conducted either in person or virtually, with video required.
About Us
IPS, a Berkshire Hathaway company, is a global leader in technical consulting, architecture, engineering, procurement, construction management, commissioning, qualification, and validation services for technically complex facilities. Integration is how we think and work. It requires the ability to unite existing and emerging technologies into a process that reliably delivers products and accelerates speed to market. That end-to-end mindset allows us to be agile and anticipate challenges as we move projects toward operational readiness. IPS applies design and delivery expertise, client-side experience, and supplier-side insight to every project. We infuse our curiosity, our passion, and our commitment to partnership in delivering solutions at any scale. We meet our clients where they are and get them to where they need to go. That's only possible when we care as much as our clients do.
Specialties
Process Architecture, Process Design, Engineering, Construction, Commissioning, Qualification, LEAN Project Delivery, Strategic Master Planning, Energy Conservation Management, Project Controls, Program/Project Management, Operations/Logistics Strategy and Planning, EPCMV, and Staffing Services.
All qualified applicants will receive consideration for employment at IPS without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law. IPS is proud to be an affirmative action and equal opportunity employer.
Connect With Us!
If you do not meet the qualifications for this specific role, but would like to submit your resume for general consideration, please click here!
Plasma Center Technician-Bilingual Portuguese
Worcester, MA job
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 and Terms of Use. I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Description
Please take this virtual tour to get a sneak peek of one of our Plasma Donation Centers.
About the role:
Every day, the donors you meet will motivate you. The high-quality plasma you collect will become life-changing medicines. Here, a commitment to customer service and quality is expected. You will report to the Plasma Center Manager and will perform as a plasma donor screener and perform phlebotomy to support plasma center operations.
How you will contribute:
· You will answer phones, and greet and focus on our donors, while ensuring the safety of donors and our team.
· You will screen new and repeat donors and take and record donor vital signs and finger stick results.
· You will use our Donor Information System, prepare donor charts, maintain accurate records, and coordinate donor compensation.
· You will help identify operational opportunities for continuous improvement and initiate changes to center processes using company approved procedures.
· You will be there for our donors, which includes working a variety of shifts, Saturdays and Sundays, and holidays.
What you bring to Takeda:
· High school diploma or equivalent
· Ability to walk and/or stand for the entire work shift
· Will work evenings, weekends, and holidays
· Ability to lean, bend, stoop, crouch, and reach above shoulders and below knees
· Ability to lift to 5 lbs., and occasional lifting of materials up to 32 lbs. and rarely 50 lbs.
· Fine motor coordination, depth perception, and ability to hear equipment from a distance
· Because of potential exposure to bloodborne pathogens (risk level 1), 90% of work tasks require prolonged glove wear
· 1 or more years minimum experience working in a customer or patient facing role is helpful
What Takeda can offer you:
Every day at Takeda, we feel good knowing that what we do helps improve the lives of patients with rare diseases. At BioLife, while you focus on our donors, we will support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program to include retirement benefits, medical/dental, family leave, disability insurance and more, all in a fast-paced, friendly environment.
More about us:
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to provide Better Health and a Brighter Future to people around the world.
BioLife Compensation and Benefits Summary
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:
USA - MA - Worcester
U.S. Starting Hourly Wage:
$19.50
The starting hourly wage reflects the actual starting rate for this position. The actual hourly wage offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - MA - WorcesterWorker TypeEmployeeWorker Sub-TypeRegularTime TypePart time
Job Exempt
NoIt is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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