Validation Engineer II

Role Summary

You will provide guidance in validation strategy to the site and global projects. You will have engineering validation signatory responsibility for approval of cleaning cycle development and cleaning validation protocols and final report documents. You will assess and validate cleaning processes. Primary tasks include 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. This position will provide interpretation of regulatory requirements. You will work in close cooperation with the manufacturing departments, Engineering, Regulatory, QC, and Quality Operations on a daily basis.

Responsibilities

• 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. Must demonstrate planning, coordination.
• 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. Emphasis is on ensuring accuracy and integrity on validation documentation meets regulatory guidelines and industry standards.
• 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.

Qualifications

• Required: Bachelor's degree in engineering discipline; Chemical, Mechanical, or Electrical Engineering preferred. 2+ years of related experience.
• Required: Minimum 2+ years validation experience.
• Required: Experience in manufacturing processes and cleaning processes.
• Required: Experience and proficiency in pharmaceutical/biotech validation elements, including writing and completing protocols and standard operating procedures.
• Required: Strong comprehension of operating principles in a cGMP regulated environment. Hands-on Manufacturing, Engineering and/or Technical Service experience is a plus.
• Required: Ability to work independently and as part of a team; demonstrated ability to produce results in a cross-functional team environment with minimal supervision.
• Required: Leadership skills and excellent technical writing, communication, and organizational skills.
• Required: Solid technical understanding of Quality Engineering and validation element principles; scheduling project overviews without assistance.
• Required: Proficiency with Microsoft Office (Word, Excel, PowerPoint, Visio, Project).
• Required: Ability to prioritize multiple projects and manage time efficiently to meet timelines.
• Required: Effective communication at all levels in verbal and written form, including technical/business writing.
• Required: Ability to identify opportunities for optimization of processes within the department or site.
• Preferred: Experience in problem analysis and resolution.

Skills

• Quality Engineering principles and lifecycle validation concepts
• Regulatory knowledge including GMPs, FDA, EU, JP guidelines
• Statistical problem-solving tools (FMEA, DOE, QbD, SPC)
• Documentation and report writing for validation protocols and final reports
• Cross-functional collaboration and project coordination
• Technical writing and communication

Education

• Bachelor's degree in engineering required (Chemical, Mechanical, or Electrical preferred)

Additional Requirements

• May be able to lift, push, pull and carry up to 25 lbs.
• Combination of sedentary work and walking around observing conditions in the facility.
• Work in office environment with requirements to work in manufacturing and support areas; controlled environments requiring gowning and protective clothing; avoidance of makeup and certain accessories in manufacturing areas.
• May work in hot/cold, wet environments and climb into large processing tanks; work in Cleanrooms and cold/hot storage conditions.
• Ability to work in confined spaces (e.g., attic spaces, engine rooms, tanks) and in loud areas requiring hearing protection.
• Work around chemicals requiring protective equipment; respiratory protection as needed.
• Ability to work multiple shifts, including weekends and extended hours, as required.
• Travel up to 5% to other Takeda facilities to manage projects or engage with validation colleagues as part of professional development.