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92,000+ live jobsManufacturing Specialist III
On-site in León·Full-time·Added yesterday (last checked 31 Oct)
17 open roles
Our summary
- Work mode
- On-site, León
- Contract
- Full-time
- Spanish
- Fluent
- English
- Required
- Experience
- 4+ years
- Education
- University degree
Visa options
The ad rules out sponsorship
The advert says visa sponsorship isn’t available for this role.
Skills
This job advert was originally written in Spanish.
Requirements
What we're looking for
- Minimum professional experience of 4 years, preferably in the sterile pharmaceutical products industry or aseptic processes.
- University degree, preferably in Engineering, Pharmacy, Biology, Biotechnology, or related disciplines within the biosanitary field.
- High level of oral and written communication in Spanish and English.
- Solid knowledge of pharmaceutical manufacturing processes.
- Adaptability, flexibility, and orientation toward change.
- Ability to work cross-functionally with different departments and manage multiple priorities.
The role
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The Manufacturing Specialist III is responsible for providing technical support to the Manufacturing team in a wide variety of complex tasks, ensuring compliance with FDA requirements and other regulatory authorities, as well as all applicable safety and quality standards.
Works in close collaboration with the Quality, Development, and other Operations departments, as well as with support functions, to execute the necessary technical activities in the manufacturing processes. This position will act as a Subject Matter Expert (SME) in the operating processes and is expected to participate actively in their continuous improvement.
What you'll do
- Comply with all work and manufacturing procedures in accordance with GMP regulations.
- Lead initiatives aimed at resolving aspects related to regulatory compliance in the Production area.
- Prepare, define, and review high-complexity manufacturing documentation (instructions, guides, and procedures). Design procedures that allow for the selection of the most suitable solutions for the department and the company.
- Deliver and coordinate training for plant personnel on the developed procedures.
- Lead the management of quality events (change controls, deviations, and corrective and preventive actions) to ensure the maintenance of the quality standards required in the plant.
- Perform the review of manufacturing documentation and batch records.
- Identify, promote, and execute continuous improvement initiatives, making decisions on the most appropriate operations to optimize implemented processes, improve efficiency, and generate time and cost savings, while always maintaining the required quality standards.
- Participate actively in new production projects, leading from the department the identification of operational needs, the adaptation of procedures in accordance with GMP Annex 1, and coordination with material suppliers when necessary.
- Establish work priorities based on the defined planning.
- Provide technical knowledge regarding manufacturing equipment, participating in testing, validation, and qualification activities, working with multidisciplinary teams, and autonomously leading the activities assigned from Production.
- As an SME, participate in manufacturing operations when necessary to provide training, technical support, and guidance to personnel.
- Collaborate actively in the continuous improvement of working conditions.
- Promote and apply company values in decision-making, driving talent development, teamwork, transparency, flexibility, and the professional development of the team members.
Safety Responsibilities
- Ensure that manufacturing area activities are carried out in accordance with corporate Health, Safety, and Environment standards and programs.
- Collaborate in the investigation of accidents and incidents, as well as in the definition and implementation of preventive measures.
- Ensure that work areas are maintained in optimal conditions of order and cleanliness, complying with established safety and hygiene standards.
About PCI Services
In their own words
Additional information
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
At PCI, Equity and Inclusion are at the core of our company's purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity - at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.
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