1+ months

Technical Specialist, Clinical Manufacturing

Pfizer
Andover, MA 01810
Why Patients Need You Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members, who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need, when they need them.



What You Will Achieve The Technical Specialist, Production Support is part of a multi-disciplinary team responsible for cGMP production of phase I/II clinical drug substance supporting the Pfizer Biotherapeutics portfolio.



The successful candidate will be a part of a team responsible for the execution of media & buffer formulation, Clean Out of Place (COP) & autoclave operations, and weighing and dispensing of raw materials to support Production Support operations.



This is position is for first shift, Monday-Friday approximately 7AM - 4:00 PM



How You Will Achieve It

**ROLE RESPONSIBILITIES**



+ Support execution of solution formulation and Weigh/Dispense operations in a GMP environment

+ Support equipment set up, CIP, SIP, Clean Out of Place (COP)/Offline Parts Washing and Autoclave operation

+ Support troubleshooting of production support equipment and operations

+ Performs routine standardization and functional checks for process instrumentation for daily use in production

+ Completes work instructions and maintains clean room environment to comply with regulatory requirements

+ Supports material handling activities, including picking of materials to GMP manufacturing facility and finished product from production to interim storage (cold and frozen storage).

+ Works on routine assignments per written procedures with minimal guidance from supervisor.

+ Adheres to good manufacturing practices and standard operating procedures, and material sampling instructions.

+ Maintains a safe work environment.

+ Completes peer/manufacturing review of batch records and forms.

+ Effectively uses process automation systems (i.e. Delta V and OSI/Pi Historian) and supporting business systems (i.e. Microsoft Dynamics/SAP/ERP Systems, Trackwise, Document Management Systems, Microsoft Sharepoint etc.).

+ Reviews work throughout the process and at completion, in order to ensure that it has been performed properly.

+ Supports planning/organization of work to ensure that activities are performed effectively, and to respond to fluctuating workloads.

+ Cross-functional communication with technology transfer teams, lab scientists, supply chain, quality and engineering as necessary

+ Engages in and supports culture of continual improvement through ownership of improvement for work processes, equipment and safe work environment. Advises Shift supervisor on improvements which may optimize work processes.



Qualifications

Must-Have



+ HS diploma, Associates Degree, or BS/BA in Biotechnology, Microbiology, Cell Biology, Chemical Engineering, Biochemistry or equivalent.

+ Requires a minimum 3- years of experience in a biotechnology manufacturing or laboratory environment

+ Experience in cGMP (Current Good Manufacturing Practices) compliance as related to manufacture of biologics

+ Ability to think critically and demonstrate troubleshooting and problem-solving skills

+ Strong workload planning skills, organization, and attention to detail, and follow through

+ Excellent written and verbal communication skills

+ Strong computer skills in Microsoft Office required e.g. MS Word, MS Excel



Nice-to-Have



+ 3-5 years experience in a Biological Pilot Plant, cGMP Clinical or Commercial Manufacturing setting

+ Understanding of solution preparation unit operations, operation of production support equipment and equipment cleaning fundamentals.

+ Familiarity with Production Control Systems (i.e. DeltaV), ERP Systems (i.e. Microsoft Dynamics and/or SAP) and other business systems (Document Management Systems, LIMS, Microsoft Word, Excel, etc.)

+ Familiarity with Quality Management and Change Management Systems (i.e. Trackwise)

+ Ability to follow Standard Operating Procedures and work under minimal supervision.

+ Fundamental mechanical aptitude and ability to interface with computerized systems required.

+ Demonstrated capability to work as a team member in a matrix manufacturing team.

+ Excellent oral and written communication skills.

+ Must be able to climb flights of stairs, and be standing for ~1-2 hours at a time.

+ Must be able to lift up to 25lb

+ Practical knowledge of the use of Personal Protective Equipment (PPE) to handle hazardous materials throughout site

+ Ability to work off shift (Off Normal Shift Hours and Weekends) as needed; non-routine

+ Ability to work in a clean room environment

+ Familiarity with and ability to use respirator or PAPR (Non-Routine)



+ Eligible for Employee Referral Bonus

+ \#LI-PFE



**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.



Manufacturing

Categories

Posted: 2020-09-21 Expires: 2020-11-20

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Technical Specialist, Clinical Manufacturing

Pfizer
Andover, MA 01810

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