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Cencora PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world. Cencora PharmaLex offers professional development, plus a stimulating and collaborative work environment. We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
PREFERRED QUALIFICATIONS
- 5+ years of engineering experience in a manufacturing support environment with at least 3 years experience in the Pharmaceutical or Biotechnology industries.
- Experience in Drug Substance Operations with Mammalian Cell Culture, Protein Purification, Media and Buffer Preparation, Clean Utilities, CIP, SIP and Production Services.
- Direct experience in process control engineering and troubleshooting with bioreactors, centrifuges, chromatography columns and systems, and/or ultrafiltration/diafiltration systems.
- Experience with Tech Transfer, Process Design, Commissioning, validation and change control methodology.
- Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) including detailed understanding of cGMPs.
- Excellent written and verbal communication skills and the ability to work with minimum direction.
- Interpersonal and facilitation skills and ability to work in a collaborative team based environment.
- Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information.
- Ability to lead and influence cross-functional teams and embrace a team-based culture.
- In-depth knowledge on Rockwell Automation Platform and Allen-Bradley
- Strong knowledge in programing language
- Direct hands on experience with lifecycle management of Rockwell hardware and software infrastructure preferred.
- Understanding of Operational Excellence and Lean transformation in the automation and engineering Context.
- Ability to create, update and read P&IDs, instrumentation and electrical design packages including SDS, URS, IQ, OQ and VSR among other engineering and validation documentation.
- Work schedule flexibility to support 24/7 operations and after-hours engineering coverage.
- Experience in change control, non-conformance, corrective and preventative actions, and validation practices.
- Familiarity with validation processes and documentation in a highly regulated environment.
- Comprehensive understanding of validation protocol execution and knowledge of validation processes as applied to new equipment installations.
Skills in the following areas:
- Problem solving and applied engineering
- Verbal and writing communications in English and Spanish
- Validation Protocol Writing
- Dealing with and managing change
PharmaLex is an Equal Opportunity Employer.
Top Skills
What We Do
PharmaLex is a leading provider of specialized services for the pharma, biotech and medtech industries.
We guide you from early strategic planning activities and non-clinical requirements through clinical development, regulatory submission processes and post-approval/maintenance post-launch activities. Our experts use technology enabled solutions to support you through the entire product lifecycle. We deliver exceptional results - going above and beyond the standard to deliver tailor-made solutions worldwide.
The PharmaLex Group now has over 3000 employees, with 68 offices in 32 countries and more than 1000 satisfied clients worldwide.