Technical Specialist – Change Controls Contract role Cork

The primary focus of the Technical Specialist is to work with External Partners and provide Technical Support

• Technical support of vaccine drug substance and/or drug product processes
  • review manufacturing documents including batch record check, standard operating procedures, job aids, and protocols
  • process troubleshooting,
  • support manufacturing investigations, and
  • review analytical results
• Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
• Collaborate across multiple technical functions
• Author process change control documentation, technical communications, and process risk management.
• Provides technical oversight, management, and planning support for complex partnership models.

• Provides technical guidance to the External Partner,
• Leads team for identification and assessment of partner risks and develops mitigations plans.
• Provides manufacturing process support to External Partner(s)
• Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites
• Provides a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility
• In concert with Operations, Quality, and Regulatory, ensures that External Partner(s) are inspection ready for all new product introductions and transfers.
• Understands the true regulatory requirements and partners with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
• Collaborates with External Partners to achieve business goals and to establish a common culture.

Education Requirements:

• A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.

Skill Requirements:

• Minimum of 2 to 4 years post-bachelor’s degree experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required
• Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues is required
• Excellent leadership, collaboration, change management, interpersonal, analytical skills, collaboration, and engagement as a team player with dependable interpersonal and communication skills (both verbal and written) is required.
• Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred
• Creative, innovative, thinks outside of the box, self-motivated, applies problem-solving skills, and solid base in engineering fundamentals and process troubleshooting is preferred