Manufacturing Process Investigator/ Pharma Industry

Pioneer Data Systems, Inc; Andover (MA); Vor Ort; USD 80.000 - 100.000; Vollzeit

Zusammenfassung

Pioneer Data Systems, Inc is seeking a Manufacturing Process Investigator located in Andover, Massachusetts. This crucial role demands a scientific or engineering background and necessitates between 2-6 years of relevant experience in the pharmaceutical industry.

The candidate will oversee investigations relevant to biopharmaceutical manufacturing, ensuring timely reporting and compliance with quality standards. Strong collaboration and technical writing skills are paramount for success in this position.

Qualifikationen

• BS + 4-6 years experience or MS + 2-4 years experience in pharmaceutical manufacturing.
• Experience with investigations in a cGMP and Quality environment.
• Understanding of biopharmaceutical manufacturing processes.

Aufgaben

• Conduct detailed investigations and generate comprehensive reports.
• Collaborate with operational leadership for effective investigations.
• Ensure compliance with quality standards during investigations.

Kenntnisse

Collaboration

Problem-solving

Continuous improvement methodology

Technical writing

Ausbildung

BS or MS in scientific or engineering discipline

Jobbeschreibung

Manufacturing Process Investigator/ Pharma Industry

I am Zach from Pioneer Data System, Inc. We have an immediate requirement for a Manufacturing Process Investigator/ Pharma Industry in Andover, Massachusetts.

If you are interested please call me at [phone] or respond to this email.

Job Title: Manufacturing Process Investigator/ Pharma Industry

Duration: 12 Months

Location: Andover, Massachusetts

Job Description: A BS or MS, preferably in a scientific or engineering discipline. Minimum qualifications: BS + 4-6 years experience or MS + 2-4 years experience in a pharmaceutical and/or biological manufacturing operation with a strong technical background in a cGMP and Quality environment.

• Prior experience with investigations including conducting and writing investigations and use of continuous improvement methodology preferred.
• The incumbent must be a collaborative team player with strong coordination, facilitation and writing skills.

The Andover Site Operations Management group is looking for an individual to fill a Lead Investigator position within the Andover Site Investigations group. The Andover Site Investigation group is responsible for overseeing investigations for all GMP manufacturing suites in Andover, including both mammalian and bacterial based processes in support of commercial and clinical Drug Substance manufacture. The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. This position will report to the Manager of Investigations within the Site Operations Management Function.

Role Responsibilities: The candidate will be responsible for performing thorough, detailed and timely investigations and generation of high quality and timely investigation reports. The individual will be expected to develop collaborative relationships with the operational leadership and staff in each suite and the appropriate Quality and Functional Area representatives in order to facilitate investigations using continuous improvement techniques. The incumbent will be expected to have experience in the area of quality and compliance and a working knowledge of the appropriate regulations. Experience with and in depth understanding of cell culture and chromatography is highly desirable. They will be expected to assist in continually defining and improving the philosophy and justifications involved in investigations and to continually evolve to meet changing business needs.

• Have a fundamental understanding of the investigation process as it applies to manufacturing issues.
• Have detailed understanding of the processes and systems involved in the manufacture of biopharmaceuticals and be able to use that knowledge to investigate process deviations and atypical results and identify root cause.
• Work with the appropriate people from both the quality and operational organizations to develop a corrective action.
• Ensure their investigations are conducted with a strict adherence to appropriate quality and compliance standards.
• Exercise judgment in developing practices, techniques and evaluation criteria for obtaining results.

Need only on W2 no C2C.