TakedaPharmaceutical Nordics AB ยท 18 hours ago
Validation Engineer II
Social Circle, GA
Full-time
Onsite
Entry, Mid Level
$70K/yr - $110K/yr
2+ years expTakedaPharmaceutical Nordics AB is committed to transforming patient care through innovative pharmaceuticals. The Validation Engineer II will guide validation strategies, assess cleaning processes, and lead validation activities, ensuring compliance with regulatory standards and industry guidelines.
Pharmaceuticals
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
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
Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus
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
Should have experience in problem analysis and resolution
Preferred
Chemical, Mechanical, Electrical Engineering Degree Preferred
Benefits
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.
Company
TakedaPharmaceutical Nordics AB
Takeda Pharma AB is engaged in sales marketing For USA
11-50 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase