Process Specialist II
Job Posting for Process Specialist II at Pfizer
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
You will have knowledge of process equipment and systems and manufacturing operations with the primary responsibility to execute process and equipment operation activities during manufacturing operations. Due to your expertise in the manufacturing domain, you may participate in training for operational qualifications and assist the Team Lead or other team members as needed. You will conduct all activities in accordance with Company policies and standard operating procedures, Pfizer Values, and global regulatory guidelines, environmental guidelines etc.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
ROLE SUMMARY
The Process Specialist II in manufacturing operations is responsible for execution of the manufacturing process in a multi-product cGMP facility capable of manufacturing commercial, clinical and development drug substance. Additional roles include using operational and technical knowledge to perform troubleshooting activities, assist with tech transfer and start-up activities, provide investigations support, analyze process data, and identify and implement moderate process improvements.
ROLE RESPONSIBILITIES
- Execution of relevant process activities including protein purification or cell culture operations (depending on the background of the candidate), solution formulation, and equipment preparation (set-up, CIP, SIP) by following established SOP’s.
- Setup and evaluation of unit operations, executions, and changeover (daily and long-term)
- Troubleshooting of moderately complex process disturbances, identifying resolution and implementing corrective and preventive measures, as required.
- Real time assessment of process performance.
- Individual will be required to perform process monitoring, and data analysis, and data preparation for presentation in several forums including project team meetings.
- Serve as the operations point of contact for technology transfer and start-up of products by reviewing process parameter tables and review applicable documentation.
- Provide input for process overview presentations, sampling plans, and other tech transfer deliverables.
- Should be capable of managing inter-departmental projects and performing relevant presentations.
- Individual will provide subject matter expertise in supporting process and author product related investigations, execute CAPAs, and provide impact assessment to moderately complex process and equipment change controls to ensure a robust and capable solution.
- Individual will help to ensure the equipment and facilities are maintained in a GMP compliant state at all times.
- The individual will be responsible for collaborating within the department as well as other departments to communicate and coordinate activities.
- Individual will assist in inventorying, tracking, maintenance scheduling, and troubleshooting of mechanical equipment.
- Individual will be responsible for modifying and/or creating job related documentation.
- Individual will assist in the evaluation and implementation of new technology for process execution and/or analysis.
- Individual will be expected to participate and drive in continuous improvement and innovation initiatives. Individual is expected to be an M1 lead.
- Individuals are responsible to ensure a safe work environment and to lead job hazard analysis opportunities.
- Individuals will be required to display multi-tasking skills.
- Identifies the need for escalation and/or remediation with various levels of management when there is a risk to operations, personal safety, equipment functionality, product supply and/or to quality/compliance.
QUALIFICATIONS
With Engineering Degree or equivalent
- Applicant must have HS Diploma with six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience
- MS (related)
Engineering Degree or equivalent
Nice-to-Have
- Experience within the pharmaceutical industry.
- Experience with Six Sigma or other operational excellence programs.
PHYSICAL/MENTAL REQUIREMENTS
- Daily routine may require moving heavy equipment, standing for long periods of time, and/or walking throughout the suite including up and down stairs.
- Must have the ability to lift ~50 pounds.
- The incumbent needs to take the necessary safety precautions when working with pressurized systems, steam and/or corrosive chemicals.
- The incumbent is required to attain detail knowledge of the operational equipment.
- The incumbent will be required to solve problems regarding site assessment, specific units used in Biopharmaceutical manufacturing.
- The incumbent must be able to express ideas into SOPs, MFRs and be able to use a multitude of programs including Excel, Word, Power Point, etc.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
1st shift 6am -6pm, rotating
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 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. This position requires permanent work authorization in the United States.
Salary.com Estimation for Process Specialist II in Andover, MA
$82,195 to $104,072
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