Sr. Process Engineer - Operations Professional (Compliance)

Employer
Pfizer
Location
McPherson, Kansas
Posted
Jul 30, 2021
Ref
4819139
Required Education
Bachelors Degree
Position Type
Full time

ROLE SUMMARY

The Sr. Process Engineer/Operations Professional (Compliance) is a role within McPherson Operations supporting technical business needs related to all aspects of manufacturing. This role is the Operations lead overseeing and driving performance, consistency and compliance within Investigations, CAPA, Change Control and Operations metrics.  The role will lead continuous improvement activities including cost improvement initiatives and Operational reliability.  This role partners with the business units on new product/processes including development, implementation, and life-cycle management phases.   This role will also partner with Quality Investigations on issue resolution including root-cause analysis and CAPA development, ownership and execution. 

ROLE RESPONSIBILITIES

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.

BASIC QUALIFICATIONS

  • BS in Engineering or BS in a related technical discipline.

  • 4+ years of pharmaceutical experience in Operations, Engineering; 6+ years in other Manufacturing/Operations or Engineering.

  • 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.

PREFERRED QUALIFICATIONS

  • 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

Limited travel required.  Non-standard work hour support of global conference calls, 24/7 manufacturing, etc. required when needed, though not typical of weekly requirements.

OTHER JOB DETAILS

  • Last Date to Apply for Job: August 05, 2021.
  • Eligible for Relocation Assistance: No
  • Eligible for Employee Referral Bonus: Yes

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

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