A career with MilliporeSigma is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
As the Head of Manufacturing and Engineering at the Carlsbad Gene Therapy and Viral Vector Manufacturing site, the successful candidate will be responsible for overseeing the maintenance, validation & qualification of our facilities, utilities and equipment that are required to produce high quality and compliant drug products and drug substances. The primary role will be to manage the maintenance & engineering teams, developing and driving appropriate performance KPIs, managing timelines and working with site stakeholders to successfully deliver customer deliverables. He/she will work with the leadership team to identify and prioritize areas for improvement and encourage good change management practices for production of drug substance and drug products for gene therapy and oncology applications.
Who You Are:
- BS degree in Engineering, Construction Management, or other related technical / science / engineering related field.
- Minimum of ten (10) years’ experience in facilities or plant engineering and project management.
- FDA-regulated medical device or pharmaceutical industry experience is a plus.
- Hands on experience with calibration of manufacturing and/or laboratory equipment.
- Excellent written and verbal communication skills as well as computer skills including, spreadsheet capability, Microsoft Excel, Word and data base management. SOP writing skills required.
- Ability to handle multiple projects, work proficiently and accurately while still completing projects on time.
- Responsible for overseeing the maintenance, validation & revalidation of facilities equipment including, but not limited to: Controlled Environment Areas; plumbing; HVAC / mechanical; electrical; purified water; clean dry air; compressed gases; vacuum; machinery; monitoring and control systems; buildings; structures; AV systems; access control systems, and other aspects of facilities and property.
- Responsible for overseeing assigned equipment validation/qualification activities and maintaining the requalification and calibration program.
- Responsible for related compliance documentation for risk assessments, qualifications, validations, plans and reports for regulatory agency compliance including required environmental reporting, the maintenance of required local, state, and federal permits and reporting.
- Validation contact for FDA inspections; also assists in providing information and documentation during onsite customer audits.
- Assures that out-sourced facility maintenance and building and grounds services are performed at a high-quality level, timely, and within budget cost constraints. Ensure Contractors are trained and comply with GMP's and required internal procedures.
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.