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Manufacturing Engineer

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Jobs by Experience drjobs

5-7 years

Job Location drjobs

Irvine - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Job Description

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements.
Our goal is to skyrocket our clients success, and you can be a part of our team s achievements. Employing a global team of skilled professionals and experts that span across strategically located offices in North America, Europe, Asia and the Middle East, we are proud of the roles we have fulfilled to help our clients achieve success.

The Experience

With operations spanning the globe and featuring a multi-cultural team, PSC Biotech is passionate about bringing the best and brightest together in an effort to form something truly special. When you make the decision to join our team, you will be offered the ability to feel inspired in your career, explore your professional passions, and work alongside a group of people who will value and nurture your talents.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. As such, you will not only be offered compensation and benefits structure that rewards you, but also be provided with the tools that will help you grow and learn.

At PSC Biotech , it s about more than just a job it s about your career and your future.

Your Role

The incumbent will collaborate with peers to manage performance of equipment, systems, and processes; and will work to improve the output, efficiency or quality of the associated manufactured products.

  • Provide support to manufacturing as the first line of contact for technical and operational equipment/process issues. Troubleshoot and investigate equipment problems in the manufacturing facility, coordinating with appropriate teams to resolve issues and prevent reoccurrence. Provide technical information, training, and coaching for process-related matters within production to maximize process understanding and enhance knowledge-based decision-making.
  • Author and improve manufacturing documentation (procedures, batch records, training materials, work instructions, etc.). This function involves creating, revising, and withdrawing documentation, including ownership of related CAPAs.
  • Maintain knowledge of the relationship between the process, the equipment, and the automation in the facility. Ensure that equipment works to its specification and capacity. Identify and implement continuous improvement projects to ensure safe and efficient operations.
  • Learn, understand and work within a matrix organization to resolve issues and drive performance.
  • Own or assist with investigations related to product and process including complaints, deviation, or adverse process trends within the Product Business Line Manufacturing.
  • Coordinate with vendors and supplier management for third party complaints.
  • Interface with maintenance, metrology, engineering, and quality during troubleshooting of manufacturing issue.
  • Ensure protocols are executed as intended.
  • Support execution of process validations and annual monitoring of batches.
  • Liaising with manufacturing, shop floor QA, and maintenance to ensure accurate process execution.
  • Other duties as assigned.


Requirements

  • Bachelor s degree or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred.
  • Degree in an engineering or science discipline preferred.
  • Minimum 4 years of related industry experience required in the pharmaceutical/biotech industry.
  • Experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments is preferred.
  • Strong understanding of engineering, equipment, and automation principles.
  • Strong mechanical aptitude or knowledge of electronic / mechanical equipment is required.
  • High attention to detail in order to solve a range of routine and non-routine problems.
  • Proven organization, presentation, and time management skills.
  • Willingness to learn all areas within the Manufacturing facility and the different systems required to support continuous improvement.
  • Ability and willingness to travel is preferred.


Benefits

Offering a full suite of benefits, PSC Biotech is firmly focused on diligently investing in our employees who enable our company to fulfill our mission and achieve success. We want to promote balance, so you not only enjoy your work, but also have the time and resources to live your life happy and healthy.

  • Medical, Dental, and Vision - PSC pays 100% of all qualifying employee medical premiums and 50% for qualifying dependents
  • Insurance options for Employee Assistance Programs, Basic Life Insurance, Short/Long Term Disability and more.
  • 401(k) and 401(k) matching - PSC matches, dollar for dollar, employees investment into the 401(k) plan up to 6%.
  • PTO, Sick Time, and Paid Holidays
  • Education Assistance
  • Pet Insurance
  • Discounted rate at Anytime Fitness
  • Financial Perks and Discounts

Equal Opportunity Employment Statement:
PSC is committed to is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant s, employee s, or intern s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.

#LI-AK1

Bachelor s degree or equivalent experience in pharmaceutical, manufacturing, or equivalent industry preferred. Degree in an engineering or science discipline preferred. Minimum 1 year of related industry experience required in the pharmaceutical/biotech industry. Experience with regulated environments (i.e. cGMP, OSHA, EPA) and working in clean room environments is preferred. Strong understanding of engineering, equipment, and automation principles. Strong mechanical aptitude or knowledge of electronic / mechanical equipment is required. High attention to detail in order to solve a range of routine and non-routine problems. Proven organization, presentation, and time management skills. Willingness to learn all areas within the Manufacturing facility and the different systems required to support continuous improvement. Ability and willingness to travel is preferred.

Employment Type

Full Time

Company Industry

Pharma / Biotech / Clinical Research

About Company

0-50 employees
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