Validation Lead Job

Date: Nov 17, 2018

Location: Carlow, IE

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Requisition ID: ENG003770

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

MSD Manufacturing Division, MMD, is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that’s committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.

• Leadership activities including development, coaching and day to day management. Ensure that the
team receives appropriate resources and programmes to develop technical and other skills, to
complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
• Drive an understanding of the importance of compliance, considering an impact on GMP and
compliance and decisions made. Accountable for compliance via documentation completion, risk
assessments, review of protocols and reports, closing out preventative and corrective action,
participate in audits and inspections and proactively highlighting any issues around compliance.
• Ensure effective execution of cycle development for cleaning and/or sterilization/decontamination
processes, ensuring industry best standards and advances.
• Ensure effective execution of equipment/CTU validation programs, using Lean Six Sigma
methodologies to ensure continuous improvement. Actively drive and participate in heat
penetration/distribution studies associated with cycle development and PQ using Kaye thermal
system and biological challenges.
• Collaborate with multiple partners (e.g. MSD network, third parties, vendors, quality, project
managers, donor sites, operations and validation) in achieving excellence in validation programmes.
• Manage and support the execution of cleaning validation and validation programs i.e. Container
Closure Integrity (CCI) , Extractable Leachable & Compatibility (EL&C), filter shipping and PPQ.
• Develop, implement and ensure effective execution of the Site re-qualification program. Manage
and perform data analysis and determine conclusions reached; facilitating others to do so; make
informed decisions/recommendations around conclusions reached from data analysis, using Lean
Six Sigma methodologies as appropriate.
• Drive compliance with MSD Global Policies, Procedures and Guidelines, regulatory requirements
and execute current Good manufacturing Practices (cGMP) in the performance of day to day
activities and all applicable job functions.
• Work collaboratively to lead a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.


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Qualifications

Typical Minimum Education
o Bachelors Degree or higher preferred; ideally in a Science, Engineering or other Technical
discipline

Typical Minimum Experience for this Grade/Level
o Significant experience in a comparable role; would typically have experience leading and
setting direction for a department and adding significant value to the business; ideally in a
pharma environment, preferably GMP biopharm setting

Technical
o Equipment and process validation
o Sterile filling processes and equipment
o Knowledge of regulatory/code requirements to Irish, European and International Codes,
Standards and Practices
o Report, standards, policy writing skills required
o Proficiency in Microsoft Office and job related computer applications required
o Lean Six Sigma Methodology experience desired

Leadership:
o Focus on Customers and Patients
o Collaborate
o Act with Candor and Courage
o Make Rapid, Disciplined Decisions
o Drive Results
o Build Talent
o Demonstrate Ethics and Integrity

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

MSD is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD. No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.
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Job: Engineering Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings: 1
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


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