Manufacturing Specialist - 1st Shift

• Support the production schedule according to customer demands from a technical perspective where and when required.

• Work on and lead new projects and problem solving across the business unit to ensure compliance with local procedures and regulations.

• Review, approval and execution of commissioning and qualification activity including FAT’s/SAT’s IQ/OQ/PQ’s.

• Support NPI’s and associated equipment trials and qualifications.

• Technical knowledge in the manufactured products and production equipment used.

• Support lean manufacturing on site by writing/ updating and approving SOPs

• Lead production related product quality investigations in conjunction with Quality Assurance and other cross-functional stakeholders including the assignment and management of corrective and preventive actions. Apply investigational tools like fishbone, 5W, contradiction matrix for root cause analysis.

• Ensure compliance with applicable regulatory agencies by supporting where required, also use knowledge to drive continuity and improvement on an ongoing basis

• Support change management and lead production aspect of CPs as part of a cross-functional team including identification and implementation of relevant tasks in a timely manner.

• Conduct business in compliance with all applicable laws and regulations, company policies and with highest ethical standards.

• Support operations in maintaining a high 5S standard

• Ensure you are fully informed of Shift and Dept performance metrics and have a clear understanding on how they impact overall Site Perfect Index

• BSc in Engineering, Science, a relevant discipline, or equivalent experience required

• 5 + years in a GMP manufacturing environment (equivalent experience considered), aseptic manufacturing experience preferred

• Excellent documentation and communication skills

• Excellent analytical and presentation skills with the ability to work independently

• Ability to work towards strict deadlines

• Ability to build relationships with peers, influence without authority

Abb Vie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled.

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