Process Manufacturing Owner, St.7

Work Schedule

Environmental Conditions

Job Description

The Manufacturing Process Expert operates as a proficient root cause analysis specialist assisting a cross-functional team committed to problem-solving and continuous development activities for the site. The investigation team holds a relevant role in the Technical Unit organization. Its goal is to advance quality perfection avoid errors and deviations encourage ongoing improvement and support effective resolution of problems. This expert is responsible for advising and carrying out detailed problem source investigations to resolve sophisticated technical issues and inquiries.

Assignments specific/primary activities:

• Investigations

Address deviations collaboratively with cross-functional groups.

1. Define investigation plans.

Conduct comprehensive cause investigation for deviation events and advise or assist in defining CAPA alongside cross-functional teams.

1. Conduct Technical Analysis both inside and outside the technical department to provide technical assistance related to deviations including product Environmental Monitoring deviations manufacturing investigations resulting from OOS and site deviations.

Lead a cross-functional investigation group both within and beyond the technical department. Share updates with the Quality team Qualified person SLT and Global QA during critical or significant events (NSE).

1. Use expertise in manufacturing processes and analytical skills to pinpoint and address manufacturing problems and cultivate continuous advancement in process operations.

Support technical discussions with customers related to assigned investigations.

• Technical process knowledge

Support Manufacturing in implementing Corrective and Preventive actions (CAPA) in collaboration with Quality Specialists (QS). Proactively identify and mitigate risks.

1. Share lessons learned during Technical Unit huddles.

• Audit

Apply manufacturing process understanding and investigative abilities during client and regulatory audits for assigned deviations.

1. Support your Manager in explaining handled deviations to auditors.

• Methodology/benchmark

Give to achieving zero past due goals in Quality (CAPA Deviations) within your scope. Also support timely RFT (Right First Time) and OTIF (On-Time In Full) goals for document submission and lot release.

Relations:

Internal

• All functions and seniority levels including Site Leadership Team
• Supervisor Quality Manufacturing
• TU assigned employees (operators lead team leaders SPVs tech team)
• Quality Function

External

• Corporate functions
• Employees from other Thermo Fisher Scientific sites
• Customers
• Consulting firms
• Suppliers

Requirements

• Degree in Chemistry/CTF/Biological Sciences or similar fields or equivalent experience.

Technical competences:

Necessary

• Ability to function in a fast-paced multifaceted environment with multiple priorities simultaneously.
• Strong interpersonal and communication both written and oral.
• Strong understanding of cGMP.
• Skilled in internal and client meetings and interviews to elicit technical details from subject matter authorities.
• Proficient in using a personal computer and related software applications with Trackwise helpful.
• Ability to write handle and review GMP documentation (Deviations CAPAs) and understand main quality indicators.
• Knowledge of injectable sterile process manufacturing.

Professional Experience:

Necessary

• Experience within manufacturing industries.
• Proficiency in English and Italian.