Sr. Process Engineer/Operations Professional (Compliance)
Pfizer Inc.
Rocky Mount, NC
Job posting number: #7135227 (Ref:pf-4880803)
Posted: March 21, 2023
Application Deadline: Open Until Filled
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
You will be part of Pfizer's manufacturing division and support production, business, and other processes in a team-based environment. You will be performing activities in a variety of cross-functional areas, including support of production planning and control, total quality management, systems, manufacturing, equipment and facilities engineering, material management, and process reengineering.
As a Senior Associate, your knowledge and skills will contribute towards the goals and objectives of the team. Your ability to meet team targets will help in completing critical deliverables. Your innovative use of communication tools and techniques will facilitate in solving difficult issues between teams and help in establishing consensus.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Sr. Process Engineer/Operations Professional (Compliance) role to include:
- Actively identify and implement improvements in manufacturing procedures or processes. Apply operational excellence tools (M1, M2, Green Belt) supporting continuous improvement to deliver measurable gains/efficiencies.
- Ensure Operations team performance, consistency and compliance to prescribed cycle times for investigations, CAPA, and change control including management of Operational metrics
- Represent Operations on project teams which include: development, cost improvement, reliability, and other operation key projects.
- Provide technical expertise to lead and participate in cross-functional teams to deliver objectives on time.
- Direct and support feasibility line trials, engineering runs, batch documentation generation/updates, validation studies, regulatory submission data, and commercial launch planning.
- Liaison between project team and Operational functional leaders.
- Assist the department managers with metrics, strategic initiatives and projects.
- Supports manufacturing in executing and trouble-shooting investigations and owning CAPA to prevent recurrence.
Qualifications
Must-Have
- Applicant must have High School Diploma (or Equivalent) with eight years of relevant experience;
- OR an Associate's degree with six years of experience;
- OR a Bachelor’s degree with at least three years of experience;
- OR a Master’s degree with more than one year of experience.
- Works independently with minimal guidance.
- Must be able to work in a team environment.
- Demonstrated proficiency in influencing and motivating teams without a direct authority, presenting data, and stakeholder management.
- Proven effective verbal and written communication skills.
- Demonstrated proficiency in MS Office programs, including MS Project or equivalent.
Nice-to-Have
- Relevant pharmaceutical industry experience
- Green Belt Certification, M1/M2 Certification
- Knowledge of cGMPs and manufacturing procedures and standards.
PHYSICAL/MENTAL REQUIREMENTS
- No unique physical requirements
- Mental: Remains organized & positive in ambiguous and fast-paced, rapidly changing situations
- Interface and communicate effectively with multiple stakeholder groups
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Day Shift. Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.
Relocation support available: YES
Last date to apply: 3/31/2023
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.
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.
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.