1+ months

Manager, Validation Engineer, Solids Dosing Manufacturing

Groton, CT 06340
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Validation Engineer III supporting the Solids Dosage Manufacturing area and equipment used in the manufacture of investigational drug product (clinical supply). Supporting a wide range of technologies in the manufacturing of solid dosage forms. An individual contributor role that applies technical support and practical engineering services to develop and support implementation of new equipment and technologies, support equipment lifecycle management and support right to operate programs (including the cleaning program). This will include qualification/validation of new equipment, safety and lifecycle management support. Colleague will work closely with operational and technical teams in the manufacturing group to deliver robust manufacturing solutions. Additionally, will work with Global Workplace Solutions (GWS) Quality Assurance (QA) Analytical Research and Development (ARD) and Pfizer Global Sourcing (PGS) to support the manufacture of oral dosage form clinical supplies and solid dose process development activities.


**Technical Support (Required skills)**

+ Responsible for

+ 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, 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.

+ Support cleaning program by performing swabbing, visual inspection of equipment and writing protocol/risk assessments.


+ Bachelor or Masters degree in Mechanical Engineering, Bio-Engineering, BioMedical Engineering, or Chemical Engineering.With 8+ years of pharmaceutical industry experience will be considered.

+ 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.

**Preferred Skills**

+ Experience implementing changes/upgrades and troubleshooting of computerized operating systems through an understanding of network infrastructure and automation solutions.Including:

+ HMIs (Human Machine Interfaces)

+ PLCs (Programable Logic Controllers)

+ IDCs (Industrial Data Centers)

+ VMs (Virtual Machines)

**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.

**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.

**Other Job Details:**

+ Eligible for Relocation Package: yes

+ Eligible for Employee Referral Bonus: yes


Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Posted: 2019-12-02 Expires: 2020-02-02

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Manager, Validation Engineer, Solids Dosing Manufacturing

Groton, CT 06340

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