Process Engineer/ Change Control
Purpose
This position will be the key technical leader interface with the External Partner for the Large Molecule Vaccines External Manufacturing (ExM) organisation.
This individual will create, lead and execute Change Controls within the organisation.
This role is critical to the organisation’s ability to support in-line commercial product technology transfers of vaccine drug substance to External Partner, and support of our in-line products.
Responsibilities
1. Technical support of vaccine drug substance and/or drug product processes to EP, including but not limited to person-in-plant support, directly within the EP manufacturing facility:
* Review manufacturing documents including batch record check, standard operating procedures, job aids, and protocols.
* Process troubleshooting.
* Support manufacturing investigations, and review analytical results.
1. Support Water Runs, Equipment shakedown runs, Engineering Runs, and Process Performance Qualification (PPQ).
2. Collaborate across multiple technical functions within the organisation and the EP team to ensure successful support and commercial manufacture.
3. Author process change control documentation, technical communications, and process risk management.
4. Provide technical oversight, management, and planning support for complex partnership models.
5. Provide technical guidance to the External Partner, assess viability of technology in proposed process configurations, verify adherence to required standards, and ensure deliverables are technically sound.
6. Lead team for identification and assessment of partner risks and develop mitigation plans.
7. Provide manufacturing process support to External Partner(s) to resolve production issues and provide guidance on process and capacity optimisation.
8. Support/Coordinate/Manage investigations, with appropriate interface with other impacted manufacturing sites.
9. Provide a technical review of External Partner process change requests, deviations, and Master Batch Record changes.
10. Drive and support Continuous process verification and process performance monitoring program for all products under his/her responsibility.
11. In concert with Operations, Quality, and Regulatory, ensure that External Partner(s) are inspection ready for all new product introductions and transfers.
12. Understand the true regulatory requirements and partner with Operations, Quality, and the External Partner to develop more efficient ways to meet these requirements.
13. Collaborate with External Partners to achieve business goals and establish a common culture.
Qualifications
1. A Bachelor’s degree in Engineering or applicable Science is required. An advanced degree in Engineering, Science, or Business is preferred.
2. Minimum of 2 to 4 years post-bachelor’s degree experience in pharmaceutical manufacturing, engineering, and/or technical support of operations is required.
3. Advanced problem-solving skills and experience leading teams to resolve complex business or technical issues are required.
4. Excellent leadership, collaboration, change management, interpersonal, analytical skills, and dependable interpersonal and communication skills (both verbal and written) are required.
5. Experience in leading cross-functional teams in support of manufacturing operations at internal sites or External Partner(s) is preferred.
Travel Requirements: >25% for partner assignments outside of primary location. Travel and flexibility in partner assignment location is required; assignments may require short term travel assignments.
Skills:
change control, pharmaceutical manufacturing, Technical Support
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