Required! - Pharmaceutical Process E...
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Jun
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ragupathyrenganathan
Required! – Pharmaceutical Process Engineer – Solid Dose Manufacturing
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Org Marketing Statement

All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That’s why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.

Role Description

The Pfizer Clinical Supply Manufacturing group is currently recruiting 2 process engineers to join our group in Groton CT. The candidates will join a world class team that focuses on the manufacture of Clinical Supplies and enabling new capabilities. Our team manufactures drug product for the early phase clinical portfolio spanning all therapeutic areas (including Cardiovascular and Metabolic Disease, Inflammation and Immunology, Pain, and Oncology).

Primary focuses for the group:

• Manufacture of drug product for clinical studies

• Enable new technologies through collaboration with Drug Product Design

• Enable new clinical trial designs through collaboration with project teams

• Provide clinics and patients with novel dosage forms and work process that allow for rapid drug development and ultimately helps bring drugs to market faster.

One of the key capabilities supported by the team is Pfizer’s Portable Continuous Miniature and Modular (PCMM) initiative. https://www.youtube.com/watch?v=Xys-L9aMm6k The project consists of a newly designed processing area combining:

• Continuous manufacturing

• Facility portability for rapidly re-deployed

This position will support the Solid Dose group and include the following focus areas:

• Automation

• Solid Dose Processing

Responsibilities

Technical Support

• Responsible for technical support and lifecycle management of manufacturing facility and equipment in the Groton Solids Dosage Manufacturing (SDM).

• Working together with a vendor to prepare and conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) of process equipment and manufacturing system.

• Ensuring maintenance of equipment and utilities is carried out to the required standard. The role will develop understanding of operating windows and the impact of process parameters on product development. Utilize the appropriate data gathered and communicated to demonstrate control of equipment and processes for a diagnostic and predictive manner.

• Understanding of process scale-up, knowledge management and technical transfer coupled with experience of trouble shooting and complex issue resolution of multiple solid dose processes.

• Understanding of facility design and associated building management systems.

• Suitable understanding of engineering operations including, instruments, controls and mechanical aspects of pharmaceutical manufacturing equipment and associated services.

• Working knowledge of equipment, facility and utility asset life cycle management from initial design, procurement and vendor management through to validation and operational use.

• Planning and organizational skills to project manage the operational and financial aspects of capital projects.

• Good interpersonal, organizational and communication skills (both oral and written) and demonstrated skills in team matrix working. Proven ability to deliver technical reports and presentations.

Program Management

• Individual will be in charge of one or more of the following programs for the SDM: Safety, Cleaning, Quality, Training, and Compliance.

Other duties include, but are not limited to:

• Provide Subject Matter Expertise in multiple focus areas: Automation, Facility Support, Process Development, Capital

• Support manufacturing and drug product development by ensuring knowledge is utilized to enable complex project delivery. To report data in an efficient and concise manner that enable appropriate utilization

• Develop a technology management strategy which includes evaluation if future technology/equipment satisfies the user requirement specifications of the operation.

• Evaluate, manage, and report the process capability of the equipment and services employed in the operation.

• Conduct risk assessment of existing and new technology/equipment and manage the impact of potential failure.

• Manage complicated projects which include all operational and financial aspects. Deliver these within Pfizer system and guidelines with minimal adverse impact and maximum ROI.

• Drive quality, safety and continuous improvement related activities.

• Design and deliver training and ensure efficient use and deployment of equipment.

• Provide immediate troubleshooting and manufacturing support during manufacturing operations.

Qualifications

EDUCATION AND EXPERIENCE

Bachelor or Master’s degree in Mechanical Engineering, Bio-Engineering, Biomedical Engineering or Chemical Engineering and 8+ years of pharmaceutical industry experience will be considered.

TECHNICAL SKILLS REQUIREMENTS

Experience of a wide range of solid dosage forms of clinical drug product process development and manufacturing with a comprehensive knowledge of equipment lifecycle management. Detailed process development and formulation knowledge.

A detailed knowledge of GMP regulation, lean concept, and 6 Sigma or equivalent tool for trouble shooting.

Experience of Safe Systems of Work and risk assessment tools used in both Quality & Safety areas and the application of these in equipment and service management.

Demonstrated leadership and people skill sets to lead global working teams, and high analytical capability to develop strategic plans.

PHYSICAL POSITION REQUIREMENTS

Role requires a Groton site presence.

The job requires to operate pieces of manufacturing equipment in the Groton SDM area and requires business trips for FATs as well as business meetings (may require international travel).

Standing, walking, bending, climbing, reaching and lifting upward of 55 pounds may be required. Personal Protective Equipment such as gloves, a full Tyvek suit and breathable air or filtering face piece may be required.

EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Copy & Paste the link below to apply

https://jobs.pfizer.com/psc/recruit/EMPLOYEE/HRMS/c/LSYS_DEVELOPMENT.Z_TAM_JOBDETAIL.GBL?HRS_JOB_OPENING_ID=1009959&HRS_JO_PST_SEQ=1&languagecd=ENG&isemployee=no&utm_source=Monster&utm_medium=PPC&utm_campaign=free&



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