Commissioning and Qualification Manager

Description

• Overall management of the commissioning and qualification phase of FUE (facility, utility, and equipment) of a new packaging line program at the site in Cincinnati, Ohio.
• Work with site core functional teams on integrated schedules, resourcing management, and C&Q execution.
• Manage (and onboard where required) C&Q subject matter experts and the entire C&Q lifecycle in an efficient manner.
• Planning and coordination of C&Q activities in line SOPs.
• Deliver program updates to both senior management and senior leadership as required.
• Onboard and Manage a C&Q team to deliver this key program.
• Articulate and incorporate all C&Q deliverables into project scheduling tools and delivery outputs.
• Responsibility for meeting customer requirements and the necessary regulatory requirements as defined by FDA, EU and regional Ministries of Health as relevant.
• Drive risk assessments ensuring a well-defined risk-based approach is developed and maintained throughout the project lifecycle.
• Participate in team meetings and workshops as required.
• Generate, Execute, review and approve documentation as necessary ensuring project documentation is of the highest standard.
  
  

Qualifications

• Degree in an Engineering, Science or Computer Science discipline
• 10 Years' experience in a pharmaceutical / Medical device background.
• Knowledge of Pharmaceutical Regulatory Requirements and expectations
• Knowledge of a wide range of C&Q disciplines including Utility, Facility & Equipment qualification.
• Self-directed, self-motivated with an ability to represent the C&Q function in a high paced project environment
• Ability to work closely with key project stakeholders to maintain project delivery schedules and limit any potential delays.
• Must have previous experience in a project management role. Management of contract staff in a previous role is beneficial.
  
  

Benefits

Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus: Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.