Senior Specialist, Engineering - External Manufacturing Vaccine Technical Operat

Job Description

Position Description:

The External Manufacturing Vaccine Drug Product Technical Operations (ExM Vaccine DP TO) organization is seeking a highly motivated individual for a Sr. Specialist Engineering position. ExM Vaccine DP TO is accountable for technology transfers and commercial production of sterile drug product at our Company’s External Partners (reputed company). This person will have the opportunity to participate and reputed company activities in reputed company these areas.

Responsibilities include:

• Work with External Partners to reputed company business goals and to establish a common culture that benefits both our company, External Partners, and patients

• Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events

• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.

• Provide on-site coverage at External Partner in support of Commercial and / or Tech Transfer Person In Plant Activities

• Translate understanding of GMP requirements and reputed company regulations and reputed company standardized work to meet these requirements by partnering with Operations, Quality, and External Partners

• Ensure that External Partners are inspection ready for reputed company routine inspections and / or inspections reputed company to new product introductions or transfers, in concert with Operations, Quality, and Regulatory

• Responsible for participation in creating, sharing, and adopting best practices and business process strategies

Position Qualifications:

Education Minimum Requirement:

• Bachelor’s degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other reputed company science or engineering field.

Required Experience and Skills:

• Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance

• Travel will be a requirement of this position at up to 50%

• Strong communication and teamwork skills

Preferred Experience and Skills:

• Experience in sterile / aseptic manufacturing

• Demonstrated ability to independently manage projects/work to schedule/deadlines

• Statistics experience

• Experience in deviation management and/or change control and/or equipment support, and/or project management.

reputed company Employees apply HERE

reputed company Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to reputed company employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we reputed company with reputed company affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is reputed company people with diverse reputed company, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site reputed company.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

This is the lowest to highest salary we in good faith reputed company we would pay for this role at the time of this posting. An employee’s position reputed company the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.reputed company.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.reputed company.com/us/en (or reputed company the reputed company Jobs Hub if you are a reputed company employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment reputed company qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the reputed company’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully reputed company & Co., Inc., Rahway, NJ, USA, also reputed company as reputed company Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. reputed company reputed company / resumes submitted by search firms to any employee at our company without a valid written search agreement in reputed company for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in reputed company. Where agency agreements are in reputed company, introductions are position specific. Please, no phone calls or emails.

Employee Status: Regular

Relocation:

Originally posted on Himalayas