Validation Maintenance Manager (Hybrid)
Company: Takeda Pharmaceutical
Location: Boston
Posted on: April 25, 2024
Job Description:
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 and . I further attest that all information I submit
in my employment application is true to the best of my
knowledge.Job DescriptionJob Title: Validation Maintenance
ManagerLocation: Lexington, MAAbout the role:As the Validation
Maintenance Manager, you will provide leadership to the Validation
Maintenance Program for annual requalification of GxP manufacturing
equipment used for commercial production, including developing
validation strategy to the site and global projects. You will have
engineering validation oversight and engineering validation
signatory responsibility for approval of commissioning,
qualification / validation, and final report documents. You will
report to the Engineering Services Lead.How you will
contribute:
- Assess, qualify and validate equipment, critical systems
(utilities), facilities, computerized systems, cleaning and
sterilization processes.
- Coordinate with manufacturing and production schedules to
access equipment to perform requalification on performance,
cleaning or periodic reviews.
- Improve and adapt the Validation Maintenance Program processes
to meet demands in the manufacturing facility by building
partnerships across departments.
- Lead and represent the respective validation elements to
determine validation strategy and system validation requirements
based on concepts of life cycle to meet regulatory guidelines and
industry standards.
- Develop protocols, coordination of validation activities,
qualification/validation execution, preparing final reports and
assembly of final validation packages; generation of project plans
consisting of both initial validation efforts and
revalidation.
- Write protocols and reports, and interpret validation documents
regarding acceptability to industry standards (GMPs, FDA
Guidelines), procedures, and regulatory requirements such as (21
CFR Parts 210, 211, 600, ISO 14644, EC-Annex1).
- Plan, and schedule validation assignments and lead the
validation team to prepare protocols and material for each
activity. Guide peers in Validation and Engineering Departments to
use statistically based Quality Engineering approaches in project,
test plans and in analysis of test results.
- Review change control requests with potential impact to
validated state of validation elements, as applicable.
- Utilize Quality-Engineering tools to problem solve/troubleshoot
and assist in risk analysis (e.g., FMEA, Design of Experiments,
QbD, SPC).
- Identify gaps related to validation requirements and Global
Validation procedures to close compliance gaps as they are
identified.
- Support the investigation and closure of
non-conformances/events, corrective actions and preventative
actions.
- Participate in internal or external audits to support closure
of observations and audit items. Assist with regulatory agency
inspections and present validation strategy and protocols.
- Supervise validation personnel, contractors and outside vendors
to meet project timelines, goals and milestones. Monitor and report
validation costs including capital and expenses.
- Use validation test equipment, such as, Kaye Validator and
Ellabs loggers to support validation activities.
- Use KNEAT to develop, review and approve protocols.What you
bring to Takeda:
- Typically requires BA or BS degree preferably in the
engineering or science field.
- Must have experience leading a team and project management
skills.
- Prior experience with manufacturing processes and control
systems (e.g. Allen-Bradley PLC, Delta V, BAS, Siemens), cleaning
processes, process equipment, facilities and GMP critical support
systems is required.
- Prior experience interacting with the FDA and other regulatory
agencies .
- Proficiency and leadership in pharmaceutical/biotech validation
elements, which includes the writing and executing of protocols and
standard operating procedures.
- Expert knowledge of GMPs, FDA and EU guidelines/requirements,
is required. Must be considered a proficient Subject Matter Expert
(SME) in all validation elements.
- Understanding of cGXPs, GAMP5 and 21CFR Part 11 (as
applicable), relevant standard operating procedure curriculum,
routine project procedures, and project management.
- Can analyze, plan, and implement resolutions to technical
problems and familiarity with auditing techniques, interpreting
regulations and quality systems.Important Considerations:At Takeda,
our patients rely on us to deliver quality products. As a result,
we must follow strict rules in our manufacturing facilities to
ensure we are not endangering the quality of the product. In this
role, you may:
- Work in a controlled environment requiring special gowning and
wear protective clothing over the head, face, hands, feet and body.
This may include additional hearing protection for loud areas.
- Need to remove all make-up, jewelry, contact lenses, nail
polish and/or artificial fingernails while in the manufacturing
environment.
- Work in a cold, wet environment and climb up into large
processing tanks.
- Will work in Cleanrooms, including cold/hot storage
conditions.
- Work multiple shifts, including weekends, or be asked to work
supplemental hours, as necessary.
- Work around chemicals such as alcohol, acids, buffers and
Celite that may require respiratory protection.
- Will work mostly in office environment with requirements to
work in manufacturing and support areas.
- Must have the ability to work in confined spaces (e.g. attic
space, engine rooms and tanks).
- 20% travel may be required
- This is a hybrid role with a three day onsite requirement and
must live within a commutable distance to Lexington, MA.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
deliver Better Health and a Brighter Future to people around the
world.#GMSGQ #ZR1 #LI-MA1Takeda Compensation and Benefits SummaryWe
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:Boston, MAU.S. Base Salary
Range:$108,500.00 - $170,500.00The 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 StatementTakeda 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.LocationsBoston, MAWorker
TypeEmployeeWorker Sub-TypeRegularTime TypeFull time
Keywords: Takeda Pharmaceutical, Boston , Validation Maintenance Manager (Hybrid), Executive , Boston, Massachusetts
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