MAP Mod 1 Sr Manufacturing Systems Specialist (MSS)
Job Description
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
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your focus and ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in explaining difficult issues and establishing consensus between teams.
It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
- Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
- Develop and validate manufacturing processes for drug products.
- Create and review Good Manufacturing Practices {also cGMP} documentation, including batch records, product specific cleaning assessments, and Standard Operating Procedures.
- Supports manufacturing in trouble-shooting investigations and owning Corrective Action / Preventative Action to prevent recurrence.
- Provide operations expertise in new line/processes that the role is directly associated with/responsible.
- Lead all applicable Environmental related tasks, initiatives, training, and services that adhere to Pfizer Global Environment, Health & Safety Standards, state and federal regulatory compliance.
- Provide subject matter expert input to regulatory inspections.
- Ensure adherence to compliance and data integrity requirements.
ROLE SUMMARY
As an integral part of the manufacturing process for injectable drug products, this role will see you actively engaged in the operation of automation systems within the specialized Modular Aseptic Processing (MAP) Mod 1 facility. Your responsibilities will concentrate on hands-on floor operations, where you will receive comprehensive training to proficiently run and enhance the equipment's performance daily, ensuring smooth and efficient production processes. This dynamic position offers a unique opportunity to be at the forefront of cutting-edge pharmaceutical manufacturing, driving innovation and excellence in drug product development.
Difference between Sr MSS and MSS role is that the Sr MSS will be required to lead many activities/projects/training as well as proactively developing and implementing the CI vision and process for automation systems.
ROLE RESPONSIBILITIES
- This position will be focused on floor activities and be fully trained to operate and improve the equipment on a daily basis.
- SME for all computer-based systems/programs used in Digital Plant Operations, i.e. SCADA, SAP, AMPS, STAR, F-batch, etc.
- Position will coordinate with both Operations Excellence (CI) and automation personnel, including automation master planning.
- Maintains Automation procedures and standard operating procedures and system support.
- Provides automation expertise and operational support.
- Manage change control authoring and execution.
- Identify and lead continuous improvement projects, develop plans for own projects and lead project teams.
- Analyze operational process problems and recommend appropriate corrective and preventative actions.
- Demonstrate good planning, organizing, time management and team participation skills.
- Proficient in Alarm response
- Troubleshoots process equipment automation systems.
- Ensures operating areas maintain compliance in the automation discipline area.
- Serves as ongoing technical resource to the operating unit, overseeing that production lots are manufactured within EHS and/or GMP requirements, working to maximize production efficiency where possible.
- Liaison with QA, EHS, Engineering, Automation, IT, etc.; considered bridge between these groups and the production floor.
- Suggests/drive improvements in automation systems, equipment, and processes to improve compliance and/or efficiency.
- Mentor and guide colleagues and serve as a technical trainer, whenever necessary.
Qualifications
Must-Have
- High School Diploma or GED and 8+ years of experience
- OR an associate degree with 6+ years of experience.
- OR a bachelor's degree with 3+ years of experience.
- OR a master's degree with 0+ years of experience
- Excellent communication and organizational skills
Nice-to-Have
- Automation and equipment troubleshooting experience.
- Demonstrated execution of capital and CI projects in a production or pharmaceutical environment.
- Excellent interpersonal effectiveness and communication skills {written and oral}.
- Strong knowledge of Computerized Systems, Compliance regulations and standards
PHYSICAL/MENTAL REQUIREMENTS
Physical Demands:
- lifting/lowering up to 55 pounds, working in high elevations (above 6 feet), and reaching/standing/walking/stooping/repetitive motion.
- Able to wear safety PPE (Hard hat, body harness, face shield).
- Able to work under full clean room (GRADE C/D) environments with appropriate gowning.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
MAP operations will start on an 8-hour shift schedule, M-F 7am-330pm with rotating weekends (when required).
Weekends, holidays, and overtime may be required to meet business or customer needs.
OTHER JOB DETAILS
Last Date to Apply for Job: 3/5/24
Work Location Assignment: On Premise
Relocation support available
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.
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.
