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Senior biologics process manager

Dundalk
beBeeBiologist
Process manager
Posted: 29 August
Offer description

Job Overview:

Our client is a leading provider of biologics services that accelerates and transforms biologics discovery, development, and manufacturing globally.

Your Key Responsibilities:

* Collaborate with technical teams to collect user requirements and present innovative solutions.
* Oversee the project lifecycle, managing automation systems, integrating vendor partnerships, and implementing operational technologies.
* Support in drafting documents, conducting design reviews, and ensuring qualifications align with GAMP5 standards.
* Drive functional commitment on projects, ensuring seamless integration of automation workstreams at the site.
* Effectively manage project finances, forecasts, risks, change processes, and provide regular status reports.
* Facilitate productive project meetings, lead steering discussions, and encourage risk and problem management.
* Coordinate system handover planning and provide post-project support to on-site engineering and maintenance teams.
* Identify opportunities for continuous improvement and collaborate on joint programs with key stakeholders.
* Execute global initiatives, executing strategies, standards, SOP harmonization, program rollouts, and risk management.

Required Skills and Qualifications:

* Bachelor's degree in relevant fields with a minimum of 10 years of experience in the pharmaceutical/biological industry.
* Familiarity with biologics drug manufacturing processes and key process equipment.
* Experience in projects involving system integration, automation, instrumentation, controls, or manufacturing digitalization in the pharmaceutical/biochemical/biological industry.
* Track record of leading complex projects and cross-functional initiatives.
* Familiarity with major DCS and working knowledge of BMS/SCADA/PLC systems.
* Strong customer service, coordination, and interpersonal skills.
* Good knowledge of GMP regulations.
* Ability to work across regions, time zones, and travel domestically and internationally.

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