Technical Specialist (Change Controls)

Summary:
Our client, a biopharmaceutical company based in West Cork, is seeking a Technical Specialist (Change Controls) to serve as the key technical interface with the CMO for Large Molecule Vaccines External Manufacturing organisation. In this role, the successful candidate will be responsible for leading, creating, and executing Change Controls and supporting in-line commercial product technology transfers of vaccine drug substance to the CMO, as well as ensuring continued support for our client’s in-line products.

Responsibilities:

• Technical support of vaccine drug substance and/or drug product processes to the CMO, 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).
• 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 CMO, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
• Leads team for identification and assessment of partner risks and develops mitigations plans.
• Provides manufacturing process support to resolve production issues and to provide guidance on process and capacity optimisation.
• Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites.
• Provides a technical review of process change requests, deviations, and Master Batch Record changes. Minimises duplication of efforts between the CMO and our client systems.
• Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility.
• With Operations, Quality, and Regulatory, ensures that CMO is inspection ready for all new product introductions and transfers.
• Understands the true regulatory requirements and partners with Operations,
• Quality, and the CMO to develop more efficient ways to meet these requirements.

Qualifications & Experience:

• Bachelor’s degree in Engineering or a relevant Science field is required. An advanced degree in Engineering, Science, or Business is preferred.
• 2 to 4 years of post-bachelor’s degree experience in pharmaceutical manufacturing, engineering, or technical support of operations is required.
• Experience in leading cross-functional teams supporting manufacturing operations at internal sites or with CMOs is preferred.
• Travel Requirement: Over 25% for partner assignments outside the primary location. Flexibility in partner assignment locations is required, with short-term travel assignments as needed.