Construction Manager - Pharma - Maryland - 12-Month Contract
Are you looking for the opportunity to work with a global biopharmaceutical company? This is your chance! Our client develops and delivers life changing medicines to millions of people globally and as part of their growth, they are looking for a Construction Manager to help support operations at their Maryland facility.
With their Drug Substance (DS) manufacturing network growing rapidly, they are committed to growing their portfolio of commercial biologics products supplied worldwide and this is your opportunity to be involved!
Your main tasks will be :
- Defines the risk-based commissioning and qualification strategy for facilities and utilities equipment and Computerized Systems (CSV) and puts into action from end-to-end.
- Performs the C&Q of new, upgraded or existing assets incl. all required documentation within a given timeline and budget
- Writes and executes Impact Assessments, DQ's, IQ's, OQ's as well CSV activities
- Supports creation of Change Control's, URS's, FMEA's as well as Validation Documents and PQ's
- Participates in inspections as well as audits and drives investigations, deviations, corrective and preventive actions towards successful and compliant closure
- Assures compliance with all applicable cGMPs, regulatory requirements, safety, environmental regulations, SOPs, WI's and Company policies
- Provide leadership and act as true expert in the field C&Q
- Manage strategic partnerships with contractors and vendors
- Leads and develop associated engineers, technicians or external contributors
Qualifications :
- Degree in Engineering, Science or related discipline.
- 6-10 years of experience in pharmaceutical plant based or consultancy role
- A minimum of 5 years' experience in leading commissioning and qualification activities
- A minimum of 3 years of proven project management experience
- Previous experience managing C&Q budgets over $5 million preferred
- Previous experience with international health authority inspections as well as internal and external audits
- Self-driven and able to set own targets
- Ability to set priorities under pressure
- In depth knowledge of current GMP standards and guidelines related to equipment, utilities and facilities commissioning and qualification (e.
g. ISO, EN, ICH, FDA, ISPE)
- Previous experience working in a large matrix-managed environment preferred
- Previous experience with Trackwise, SAP and Documentum system is preferred.
- Fluent in English (written and spoken), Spanish language is beneficial
- Proactive, open teamplayer that recognizes C&Q as a service
If this role is of interest to you, please apply now!
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