Manager, Validation - Facilities, Equipment, Utilities & Qualification
LSNE Contract Manufacturing
Bedford, NH, USA
5d ago

Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement.

If this describes you, then look no further than LSNE. We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices.

Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses.

Come make a difference. Your work will matter and your contributions will be significant in these endeavors.

We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!

JOB SUMMARY

The Validation Manager for Facilities, Equipment and Utilities Qualification in the validation department is responsible for performing the Facilities, Equipment, Utilities Validation.

This role will collaborate with Engineering, MTS, QC, MFG and Quality to deliver robust and efficient qualification and validation.

The function also provides daily support to all manufacturing enabling teams as a Subject Matter Expert (SME) in Facilities, Equipment, Utilities validation for LSNE Device and Drug manufacturing.

The manager will drive the FEUQ validation strategy and project deliverables for multiple projects at all LSNE New Hampshire facilities.

The manager will assure adherence to internal procedures / quality guidelines and external regulatory requirements. The Validation Manager will be responsible for representing FEUQ during Client Audits and Regulatory inspections.

JOB DUTIES

  • Work, at all times, in a safe manner in full adherence to LSNE EHS guidelines and policies.
  • Support cGMP manufacturing operations for clinical, commercial and medical devises.
  • Responsible for the day to day Equipment, Utilities and Facility validation support.
  • Establish / Maintain Validation plans and procedures for sterilization, cleaning, environmental monitoring, Utilities qualification.
  • Ensure LSNE policies meet or exceed industry and regulatory guidelines.
  • Provide technical assessments on change controls, deviations and investigations, assessing proposed changes to validated processes to identify requirements necessary to maintain validated status.
  • Establish and implement quantifiable performance metrics (KPI's) to plan, track and report on validation departmental performance against goals and objectives.
  • Manage the FEUQ validation team and ensure that the team is meeting deliverables.
  • Develop the validation team by coaching and mentoring team members, enabling them to be efficient; productive and engaged.
  • Provide front room and back room support for client audits and regulatory audits.
  • Defends FEUQ policies, procedures and protocols.
  • Provide audit responses in a timely manner and meet all client and regulatory commitments
  • Establish / Maintain site good practices (user requirement specifications, Equipment Impact assessments, engineering / design specifications, risk assessments, etc.)
  • Author validation plans, protocols IQ / OQ / PQ, test scripts, and reports.
  • Develop, execute and document risk assessments and evaluations to determine testing strategies
  • EDUCATION

  • BS in Engineering or related Life Sciences with a minimum of (12+) years relevant experience or MS in related field with a minimum of 8+ years relevant experience preferably within a GMP manufacturing (aseptic / sterile product facilities) environment or equivalent experience.
  • EXPERIENCE

  • Demonstrated successful experience as a manager of technical personnel ( 3 5 years)
  • Experience planning, organizing, and coordinating work of validation engineers.
  • Strong working knowledge of regulatory requirements for Sterilization and Cleaning Validation.
  • Prior experience authoring and executing IO, OQ and PQ protocols and summary reports.
  • Working knowledge of risk assessment methodologies and practices including prior experience using risk analysis for testing strategy development and justification.
  • PROFESSIONAL SKILLS

  • Fully developed leadership skills to inspire and motivate team members in a creative and effective manner
  • Excellent communication and inter-personal skills coupled with the ability to problem solve, provide leadership and strategic direction
  • Demonstrated ability to collaborate with multiple functions to coordinate the execution of validation activities and incorporate validation results into routine operational practices.
  • Microsoft Office and Computer skills required (Excel, PowerPoint, and word processing)
  • QUALITIES

  • Self-motivated with a drive for excellence
  • Creative and able to work with minimal supervision following internal procedures balanced with independent thinking and judgment
  • Positive attitude and strong interpersonal skills. Resilient through operational and organizational change
  • Honesty, integrity, respect and courtesy with all colleagues
  • PHYSICAL REQUIREMENTS & MENTAL DEMANDS

  • Ability to lift 50 pounds
  • Able to don cleanroom gowning and PPE, as required by site procedures.
  • The ability to work at all LSNE site locations / Facilities.
  • COMMUNICATIONS & CONTACTS

  • Interacts with all departmental staff and maintain a professional, courteous, respectful relationship with internal cross-functional teams;
  • maintain a positive feedback.

  • Maintain a professional, courteous, respectful relationship with external and internal cross-functional teams; maintain a positive feedback.
  • May occasionally support off shift activities.

    MANAGERIAL & SUPERVISORY RESPONSIBILITIES Manages a team of 4-6 staff

    TRAVEL 10 - 15%

    The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification.

    They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.

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