Manager Process Engineering - Gene Therapy Drug Product Operations

Sanford, North Carolina, United States
Oct 06, 2020
Required Education
Bachelors Degree
Position Type
Full time

Proactively identifies areas for improved efficiencies and ensure that product quality is maintained through all phases of production including operational parameters of manufacturing equipment, automation control, processing dynamics, and integrated utilities to identify and resolve quality, and technical, risk to manufacturing.

Leading assigned process engineering staff to achieve targets and deliver and improve process or product consistency, quality/compliance, cost standards and customer service and make decisions encompassing personnel management.

Capable of leading a team to identifying technical problems and solving them with minimal guidance. Ability to analyze operational process issues and automation challenges to recommend / initiate appropriate corrective and preventative actions. Acts as a departmental liaison with primary support groups such as engineering, technical operations, quality operations and maintenance. The incumbent will manage / implement process, equipment, and automation changes in support of manufacturing operations.

Serve as the areas technical SME and develops expertise in various manufacturing operations and processes including automation controls that operate and monitor the processes.

Contribute to Project Technical Teams, communicate and collaborate effectively to ensure effective interactions with all stakeholder groups.

Requires general knowledge of scientific principles, technical knowledge of production equipment, automation control systems, processing requirements and any related procedural requirements with emphasis on assigned production area.

• Coordinate, schedule & participate in daily activities of process Engineers supporting cGPM production in the manufacturing area to meet supply chain needs.
• Ensure that product quality is maintained through all phases of process validation and commercial production including operational parameters of manufacturing equipment, personnel activities, batch record/processing dynamics & integrated utilities to identify & resolve quality risk to commercial manufacturing. General knowledge of scientific principles, production equipment & related procedures.
• Aid in investigations. Responsible for the adherence to established policies, procedures and practices. Participate in inspections and cGMP & Quality decisions effecting short term production
• Provide supervision to exempt direct reports. Motivate personnel by setting high standards, encourage teamwork.
• Responsible for development plans & personnel reviews. Make initial decisions encompassing personnel issues, disciplinary actions, career advancement, educational assistance, Emergency situations
• Identify and implement opportunities for continuous improvement
• Provide input on primary decisions on cGMP related documents developed or revised.
• Provide technical guidance and act as a departmental liaison with primary support groups.
• Short range planning includes scheduling daily and weekly operations and staff. Longer range planning concerns facilities shutdowns and preventive maintenance.

  • BS degree in Engineering or Life Science (e.g. Biology or Chemistry or similar field) or with 5-8 years of biotechnology manufacturing experience in a FDA regulated industry or MS with 2 or more years of manufacturing experience in a FDA regulated industry.
  • Around 2 years of supervisory or management experience preferred.

  • Last Date to Apply for Job: 10/20/2020
  • Eligible for Employee Referral Bonus
  • Eligible for Relocation Package

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.