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Director, Manufacturing Engineering Sterile Drug Product
Director, Manufacturing Engineering Sterile Drug ProductThermo Fisher • Mission Viejo, CA, US
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Director, Manufacturing Engineering Sterile Drug Product

Director, Manufacturing Engineering Sterile Drug Product

Thermo Fisher • Mission Viejo, CA, US
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Director, Manufacturing Engineering Steriles

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $45 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them. Our distributed team of more than 130,000 colleagues delivers an outstanding combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services and Patheon. Thermo Fisher Scientific is an equal opportunity employer.

The Drug Product Division (DPD), a business within the Pharma Services Group, operates as a Contract Development and Manufacturing Organization (CDMO) for large & specialty pharma and biotech companies. The business offers development services & commercial production of drugs, improving the life of millions of patients every day.

As a Director, Manufacturing Engineering Steriles, you will support the 3 steriles manufacturing sites in North America. This is a technical role that supports the commercial operations including root cause analysis and problem solving on infrastructure and machine issues on the sites. You will remove roadblocks and drive intensity to the operations, maintenance activities, and capital project. You will be responsible for working alongside the sites to guarantee capital project execution, establishment, and oversight for all major investments to align with the business plans. This role will be a key connection to the DPD- EU team growing consistency in the sterile network. You will collaborate with Quality, IT, Supply Chain, and Sustainability teams to ensure that the Capital, Engineering, and Maintenance teams adhere to policies, master planning, shutdown planning, and meet company commitments. This is an outstanding change to create an impact with Thermo Fisher Scientific.

Key Responsibilities

  • Technical Support Machine / Site Infrastructure
  • Master Planning and Business Continuity Planning
  • Asset Life Cycle
  • Maintenance Excellence Program
  • Fit and Finish Programs
  • Data and Information Exchange
  • Capital Project Governance
  • New Asset Start up and Readiness
  • Improve Use of GEPs to Drive Standardization

Qualifications and Requirements

  • Bachelors degree in Engineering or related field
  • Masters Degree is desirable
  • 10+ years experience in Engineering with a proven track record
  • Knowledge and experience with Sterile Pharmaceutical manufacturing and regulations
  • Knowledge, Skills, Abilities :

  • Outstanding leadership and management skills.
  • Ability to implement global standards.
  • Strong analytical and problem-solving skills.
  • Experience in leading teams and / or initiatives is helpful.
  • Self-directed with strong partner development skills.
  • Ability to lead and influence in a matrix and global environment.
  • Consistent in delivering results.
  • Compensation and Benefits

    The salary range estimated for this position based in North Carolina is $160,100.00$225,000.00. This position may also be eligible to receive a variable annual bonus based on company, team, and / or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes :

  • A choice of national medical and dental plans, and a national vision plan, including health incentive programs
  • Employee assistance and family support programs, including commuter benefits and tuition reimbursement
  • At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
  • Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
  • Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
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