Takeda · 2 weeks ago
Validation Engineer II
Social Circle, GA
Full-time
Onsite
Entry, Mid Level
$70K/yr - $110K/yr
2+ years expTakeda is a patient-focused company transforming patient care through the development of novel specialty pharmaceuticals. The Validation Engineer II will provide guidance in validation strategy, oversee cleaning process validations, and ensure compliance with regulatory requirements.
BiotechnologyHealth CareManufacturingMedicalPharmaceutical
Responsibilities
Provide guidance in validation strategy to the site and global projects
Have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents
Assess and validate cleaning processes
Development of protocols, coordination of validation activities, execution, preparing final reports and assembly of final validation packages; generation of project plans
Responsibilities will consist of both initial validation efforts and revalidation
Investigations of manufacturing challenges are conducted and process improvements are evaluated and implemented
Final documents are archived and may be included in or support regulatory submissions, and made available during internal and external regulatory/compliance audits
Provide interpretation of regulatory requirements
Work in close cooperation with the manufacturing departments, Engineering, Regulatory, QC, and Quality Operations on a daily basis
Apply thoughtful understanding of cGXPs, GAMP5 and 21CFR Part 11 (as applicable), relevant SOP curriculum, routine project procedures, and other training
Perform a variety of projects in several areas at the same time to support manufacturing and engineering
Handle projects that are more complex and broad in scope, which require team leadership and task prioritization
Review and assess change control requests with potential impact to validated state of validation elements, as applicable
Participate and work with project team members (Engineering, Manufacturing, Regulatory Affairs, Quality Operations, Quality Validation, Supply Chain, and other technical disciplines) representing the respective validation elements, as applicable, to determine validation strategy and system validation requirements based on concepts of life cycle user requirements, functional specifications, design specifications, cycle development and validation
Write protocols and reports, execute, interpret, and evaluate validation documents regarding acceptability to industry standards (GMPs, FDA, EU and JP Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, 600, ISO 14644, EC-Annex1, USP-NF, etc.)
Guide peers in Validation and Engineering Departments to use sound, statistically based Quality Engineering approaches in project, test plans and in analyses and interpretation of test results
Use Quality-Engineering tools to problem solve/troubleshoot and support risk analysis (e.g., FMEA, Design of Experiments, QbD, SPC)
Identify opportunities for optimization processes within the department or the site
Identify gaps related to validation requirements and Global Validation procedures. May guide and close compliance gaps as they are identified
Perform updates to element validation assessments and validation plans
Assist / support, as required, in the investigation and closure of non-conformances/events, corrective actions and preventative actions
May participate in the generation and updating of standard operating procedures based on operations and validations to meet divisional and regulatory requirements
Participate in internal and/or external assessments and/or audits
Support process with closure of observations/audit items
Assist with regulatory agency inspections, including interfacing with inspectors and corporate/division/internal auditors. Present validation strategy and protocols in regulatory inspections
Participate and support in Global Validation initiatives for harmonization and streamlining efforts
Perform other duties as directed by supervisor
Qualification
Required
Bachelor's degree in engineering discipline required
2+ years of related experience
Minimum 2+ years validation experience
Experience in manufacturing processes and cleaning processes
Must have experience and proficiency in pharmaceutical/biotech validation elements, as applicable, including the writing and completing of protocols and standard operating procedures
Must have a strong comprehension of the operating principles in a cGMP regulated environment
Must be able to work independently and as part of a team
Must also have demonstrated ability to produce results in a cross-functional team environment (including technical and non-technical work) with minimal supervision
Must demonstrate leadership skills
Must possess excellent technical writing, communication, and organizational skills
Must display a solid technical understanding of Quality Engineering of the validation element principles and procedures and scheduling a series of project technical and project management overviews without assistance
Must be proficient with Microsoft Office including MS Word, Excel, Power Point, Visio and Project
Must have the ability to prioritize multiple projects and manage time efficiently in order to meet established timelines
Ability to communicate effectively at all levels in verbal (soft skills) and written form, including technical/business writing
Must be able to identify opportunities for optimization of processes within the department or the site
Preferred
Chemical, Mechanical, Electrical Engineering Degree Preferred
Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus
Should have experience in problem analysis and resolution
Benefits
Medical, dental, vision insurance
401(k) plan and company match
Short-term and long-term disability coverage
Basic life insurance
Tuition reimbursement program
Paid volunteer time off
Company holidays
Well-being benefits
Up to 80 hours of sick time
Up to 120 hours of paid vacation
Company
Takeda
Takeda is a biopharmaceutical company that researches and develops pharmaceutical drugs.
10001+ employees
H1B Sponsorship
Takeda has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (45)
2024 (39)
2023 (38)
2022 (34)
2021 (44)
2020 (18)
Funding
Current Stage
Public CompanyTotal Funding
$2.46B2025-06-27Post Ipo Debt· $2.4B
2016-09-01Grant· $19.8M
2016-05-08Grant· $38M
Leadership Team
Christophe Weber
President and CEO
Schuyler Fairfield
Senior Vice President, Global Head of Supply Chain
Recent News
2026-01-09
2026-01-08
Company data provided by crunchbase