Manager, Process Engineering
Manager, Process Engineering
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Job Description
Use Your Power for Purpose
Our dedicated manufacturing support team ensures that all manufacturing activities at Sanford are conducted with the highest level of compliance and quality. By embracing challenges imagining new possibilities and taking decisive action you will play a crucial role in accelerating the delivery of medicines to the world. Your efforts will help bring essential treatments to those in need faster than ever before making a significant impact on global health. Join us in this mission to innovate and overcome obstacles ensuring that life-saving medications are always within reach for those who depend on them.
What You Will Achieve
In this role you lead a Process Engineering team which includes all activities related to proper staffing performance management training curricular assignment/maintenance and growth/development. Two roles available one supports Chemistry Trains 1 and 2 the other supporting Train 3.
Additional responsibilities include:
- Review of process requirements and evaluation of equipment and systems to ensure deliverables meet or exceed process specifications and manufacturing requirements.
- Will provide technical guidance and systems and automation training to production colleagues.
- Provides process engineering support of cGMP clinical and /or commercial manufacturing processes and equipment working with the Manufacturing Area Leads.
- Analyzes equipment and process issues and supports related investigations.
- Advise management of non-conformance issues and opportunities for continuous improvement via data trend analysis interpretation of data gap analysis and implementation of corrective activities.
- Provides input on decisions for SOPs batch records forms or other cGMP related documents developed or revised to support continuous improvement efforts investigation corrective actions process descriptions manufacturing operations automation control (DeltaV etc.) and regulatory audit commitments. Evaluates new processes for clinical or commercial production in mAb or vaccine manufacturing facilities. This includes facility fit analysis and direct input into tech transfer documentation. This may also include new capital equipment purchases and implementation of new technologies.
- Conducts all activities and makes decisions that are in accordance with Company policies & SOPs Pfizer Values & global regulatory guidelines (including cGMP/cGLP/cGCP) environmental guidelines as appropriate etc.
Here Is What You Need(Minimum Requirements)
- Applicant must have a bachelors degree with at least 4 years of experience; OR a masters degree with at least 2 years of experience; OR a PhD with 0 years of experience; OR as associates degree with 8 years of experience; OR a high school diploma (or equivalent) and 10 years of relevant experience
- Relevant experience in the pharmaceutical industry
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Provides support to second and third shift operations as needed.
Work Location Assignment:On Premise
Relocation assistance may be available based on business needs and/or eligibility.
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 providers 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. This position requires permanent work authorization in the United States.
Required Experience:
Manager
Employment Type
Full-Time
