Process Shift Lead - Full-time / Part-time

Description:

1. Support Area Supervisors to coordinate with the area planners and quality personnel, to organize and comply with daily production goals.

2. Ensures Operations personnel on his/her shift complies with the established GMP’s curriculum to achieve proper knowledge transfer and personnel qualification such as but not limited to aseptic techniques, Isolation technology, TFF, lyophilization, sanitization, inspection and packaging as applicable.

3. Ensures that area equipment is well maintained, including but not limited to calibrations and preventive maintenances, in order to achieve optimal operational performance while maintaining regulatory and compliance requirements. Area must be Audit Ready at all times.

4. Partners with MS&T, Eng and PMO to achieve sterile and/or non-sterile strategic growth product projects milestones.

5. Assures a streamlined and continuous operation between Sterile Operations and Non Sterile Operations.

6. Active participation on Tier 1 meetings to provide updates related to Par Lyo, PVA-1, PVA-2 and PSA activities.

7. Co-Manage Tier 2 meetings while keeping alignment of tools utilized on boards against latest OpEx guidelines. Monitors, evaluates and communicates area performance metrics for processes, cost and quality control.

8. Supports and lead Productivity initiative programs by identifying efficiencies in the Operational areas.

9. Supports all technology transfer activities, equipment qualification and process validation, troubleshooting clinical lots production, and process optimization by providing the necessary process expertise.

10. Provides support to the regulatory affair reports, customer complaints, and area exception reports (e.g., Quality Investigation Reports, Quality Complimentary Reports, Change Request Forms, etc.).

11. Participates actively as a key stakeholder of Sterile and/or Non Sterile operations in internal and external audits.

12. Drive continuous process improvement in order to optimize product efficiency/yields.

13. Supports the creation and revision of SOP’s, Forms and related documents to assure compliance with cGMP’s, Company policies / procedures and documentation practices.

14. Maintains environmental control process within PLA, PVA-1, PVA-2, Pharmacy and PSA areas.

15. Performs as back up in the absence of the Shift Process Leads, Sterile/Non Sterile Drug Product Operations as applicable.

16. Participate on Operations Quality GEMBA walk-downs and support managing close-out of generated actions

17. Liaison for Training Area in sustaining the metrics and compliance status for self and shift team

18. Lead changes to Batch Record and support BR Management flow to Quality Assurance teams.

19. Execute SAP/SYNCADE transactions and technical support for manufacturing processes

20. Ownership of Quality Investigations – triage process

21. Ownership of Low Risk Investigations associated to Operations.

22. Support complex investigations with MS&T investigators.

23. Campaign preparations, and campaign performance review

24. Issuing / Approving work order and any Job Hazard permits prior execution of interventions in the areas.

25. Raising Emergency change controls, deviations and Safe IMs for Operations driven events.

26. Delivery of site tours to external parties

27. Support area shutdown planning and execution according to the programmed shutdown schedules.

28. Support Area Safety Metrics and 5-stars program

Skills:

Production, Supervision, parenteral, lyophilization, Inspection, packaging

Additional Skills & Qualifications:

• BS Degree in Chemistry, Biology, Engineering, Pharmacy or related sciences.

• Sterile Support:

• Ten (10) years of experience in aseptic processes, isolation technology, including lyophilization, within a pharmaceutical environment.

• In-depth technical knowledge of the aseptic filling process, sterilization, isolation technology and lyophilization process

• Extensive knowledge and understanding of manufacturing processes associated with parenteral products in conventional aseptic and lyophilization technology.

• Non Sterile Support:

• Ten (10) years of experience in inspection and packaging operations in a pharmaceutical environment.

• In-depth technical knowledge of the inspection, device assembly and packaging process

• Project Management skillsets are necessary on this role as multiple priorities will be managed within the operating shift.

• Proven strong leadership skills while maintaining effective communication and interactions with superiors and colleagues.

• Strong business sense; understanding of and capability to support both financial and total quality objectives.

• Assertiveness and uncompromising attitude with regard to the quality standards applied in the day-to day activities.

• Ability to leverage both internal and external resources from various levels.

• Proficient in regulatory / compliance areas of cGMPs, FDA regulations, EHS.

• Strong interpersonal and teamwork skills; ability to develop and maintain effective professional relations with colleagues at all levels across the organization; ability to integrate actions toward objectives.

• Excellent and effective communication skills in both English and Spanish.

• Experience in writing technical reports, executive summary type presentations to management and technically detailed presentations to specialized technical groups such as Technical Services, Supply Chain, Engineering and QC/QA.

• Willing to work on any work shift and day of the week.

Experience Level:

Entry Level

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.