Job Title: Manufacturing Systems Specialist
As a key member of the Manufacturing Operations team, you will be responsible for establishing and managing the manufacturing systems within our biologics services organization. You will provide expert support to the manufacturing team in areas such as SAP, LIMS, finite scheduling, and benchtop equipment.
Responsibilities:
1. Establish and manage the manufacturing systems team within the Manufacturing Operations group.
2. Provide expert support to the manufacturing team in areas such as SAP, LIMS, finite scheduling, and benchtop equipment.
3. Process and system owner for manufacturing benchtop equipment.
4. Manage the MFG benchtop support, including vendors and equipment maintenance.
5. Collaborate with relevant departments on all aspects of benchtop equipment qualification lifecycle (URS to decommissioning).
6. Coordinate vendor visits on site for benchtop support, qualification, and maintenance as needed.
7. Provide input to budget planning for systems.
8. Collaborate with MT and MSAT groups on technical transfer and process validation as required.
9. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigation and CAPA implementation, and support client auditing and agency inspections.
10. Ensure that the MFG training team are supported regarding benchtop equipment training and troubleshooting as needed.
11. Continually improve manufacturing documentation (SOPs, MBRs, OJTs) for areas of responsibility to ensure they are current, accurate, and clear.
12. Communicate operational status regularly to senior management, as required, at the appropriate level of detail.
13. Assist the MFG systems lead to coordinate work between MFG systems groups and other functional groups to meet production objectives and timelines.
14. Identify and assess new models of benchtop and new equipment as required.
15. Be flexible to take on additional tasks and responsibilities at the discretion of the Manufacturing Operations Associate Director and Systems Lead.
16. Support future initiatives such as electronic batch records, electronic logbooks, etc.
Requirements:
1. Degree in Chemical Engineering, Bioscience, Biotechnology or Analytical Science.
2. More than 2 years in biopharmaceutical manufacturing.
3. Experience with GMP systems such as SAP and benchtop equipment qualification and operation.
4. Ideal candidate has a solid understanding of quality systems in terms of deviation, investigation, CAPA, and change control.
5. Experience working with cross-functional teams.
6. Strong leadership skills with the ability to manage and support manufacturing operations in a dynamic team environment.
7. Proficiency in operating a drug substance commercial manufacturing facility and/or pilot plant.
8. Good understanding of DQ, FAT, SAT, IQ, OQ, & PQ (commissioning and qualification).
9. Ideal knowledge and experience of scheduling software including Orchestrate.
Personal Skills:
1. Ability to establish a Manufacturing department and work in a greenfield context of similar size and scale.
2. Strong collaborator with the ability to adapt to daily challenges of a manufacturing work environment while maintaining a positive attitude.
3. Excellent verbal and written communication and presentation skills.
4. Excellent people skills with the ability to work effectively with staff at all levels of the organization.
5. Ability to work on own initiative and be initiative-taking.
6. Results oriented, with the ability to manage multiple priorities in a short period of time.
7. Excellent organizational and planning skills and strong diligence.
Benefits:
What we offer:
* Bonus opportunities
* Parking facilities
* Pension plan
* VHI health insurance
Reach beyond yourself and discover your true potential. We are an equal opportunities employer.