drjobs Maintenance Project Lead

Maintenance Project Lead

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1 Vacancy
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Jobs by Experience drjobs

3-5years

Job Location drjobs

Dallas, TX - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

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

We are hiring a dedicated and highly skilled Maintenance Project Lead. You will work collaboratively with cross-functional teams to ensure smooth operations regulatory compliance and drive continuous improvement initiatives. Successful candidates will be well-versed in the pharmaceutical manufacturing industry with strong knowledge of FDA and cGMP regulations and highly skilled in preventative maintenance programming. This role offers an excellent opportunity to apply strong leadership abilities while being actively involved in execution and providing specialized expertise.

  • Lead critical maintenance projects developing and maintaining preventive and predictive maintenance programs for critical manufacturing equipment and operations.
  • Review and revise current preventative maintenance processes to effectively identify areas of improvement and implement quality-driven solutions.
  • Conduct risk assessment and gap analysis driving effective CAPA implementation.
  • Support equipment qualification validation and change control processes ensuring compliance with pharmaceutical industry regulations including GMP and FDA standards.
  • Lead and execute equipment and facility improvement projects including equipment repairs installation qualifications etc.
  • Troubleshoot equipment issues and implement corrective actions to minimize downtime.
  • Maintain accurate documentation including SOPs maintenance logs and project reports.
  • Collaborate with cross-functional teams to resolve technical issues and streamline processes.
  • Collaborate with the Microbiology department to coordinate and support the requalification and routine monitoring of water systems.
  • Monitor maintenance metrics and reports to track performance and ensure alignment with organizational goals.
  • Additional responsibilities as assigned to drive continuous improvement initiatives.


Requirements

  • Bachelor s degree in Engineering Mechanical Maintenance or a related field.
  • Minimum 3-5 years of maintenance experience within the pharmaceutical manufacturing environment.
  • In-depth knowledge of GMP FDA regulations and industry best practices.
  • Proven expertise in developing and implementing preventive maintenance programs.
  • Demonstrated proficiency in establishing calibration program requirements and reviewing procedures for third-party vendors to ensure compliant execution.
  • Hands-on with manufacturing equipment repairs qualifications and installations. Proven experience with a range of laboratory equipment and operations. Familiarity with the requalification of water systems is strongly preferred.
  • Ability to make informed decisions to best lead and manage projects effectively.
  • Strong analytical problem-solving and organizational skills.
  • Excellent communication and leadership abilities.
  • Ability to work independently. Go getter and self-starter.


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-TP1

Bachelor s degree in Engineering, Mechanical Maintenance, or a related field. Minimum 3-5 years of maintenance experience within the pharmaceutical manufacturing environment. In-depth knowledge of GMP, FDA regulations, and industry best practices. Proven expertise in developing and implementing preventive maintenance programs. Demonstrated proficiency in establishing calibration program requirements and reviewing procedures for third-party vendors to ensure compliant execution. Hands-on with manufacturing equipment repairs, qualifications, and installations. Proven experience with a range of laboratory equipment and operations. Familiarity with the requalification of water systems is strongly preferred. Ability to make informed decisions to best lead and manage projects effectively. Strong analytical, problem-solving, and organizational skills. Excellent communication and leadership abilities. Ability to work independently. Go getter and self-starter. 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-TP1

Employment Type

Full Time

Company Industry

About Company

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