Energy Jobline ZR
Job Description
We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life‑saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you’ll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow. We are seeking a highly motivated and technically skilled professional with extensive experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical or biotech industry. Responsibilities: Review and refine basic and detailed designs to ensure compliance with quality and design standards. Plan, coordinate, and execute qualification and commissioning activities for new systems and equipment modifications. Develop, review, and execute qualification protocols (IQ/OQ/PQ) following GMP requirements. Identify and manage GMP and non‑GMP activities within project scopes. Oversee supplier services related to calibration and qualification, including FAT and SAT activities. Manage qualification and commissioning processes as the primary contact between Production, Engineering, and Quality departments. Execute commissioning and qualification of various systems and equipment such as:
API manufacturing units (reactors, crystallizers, dryers, centrifuges) Clean utilities (WFI, clean steam, process gases) Process equipment skids and automation systems (DeltaV, PCS7, etc.)
Coordinate with EPCM/EPC firms and cross‑functional teams including process, automation, construction, and validation disciplines. Evaluate chemical compatibilities for equipment and systems under specific process and cleaning conditions. Ensure alignment with CQV lifecycle stages (URS → FAT → SAT → IOQ → PQ). Qualifications: 5–10+ years of experience in pharma/biotech project execution (greenfield or brownfield). Proven track record of participation in large‑scale (>$50M USD) CAPEX projects from design through commissioning. Strong familiarity with GMP requirements and the CQV lifecycle. Hands‑on experience with API manufacturing systems, clean utilities, and process automation platforms. Experience collaborating with EPCM/EPC firms and multidisciplinary engineering teams. Proven experience in developing and executing qualification protocols, especially IQ/OQ. Excellent organizational, analytical, and communication skills. Bachelor’s or Master’s degree in Chemical, Mechanical, or Process Engineering. Nice to have:
Experience working with major global pharma clients. Familiarity with ISPE baseline guides, ASTM E2500, and GAMP5 methodologies.
Ability to work fully onsite in the Greater Trenton, NJ area. The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job‑related knowledge, qualifications, skills, education, training, and experience. Equal Opportunity Employer
ALTEN Technology is an Equal Opportunity Employer. Compliance & Drug Screening
Alten USA maintains a drug‑free workplace. All candidates selected for employment will be required to successfully complete a pre‑employment drug screening as a condition of hire.
#J-18808-Ljbffr
We’re ALTEN Technology USA, an engineering company helping clients bring groundbreaking ideas to life—from advancing space exploration and life‑saving medical devices to building autonomous electric vehicles. With 3,000+ experts across North America, we partner with leading companies in aerospace, medical devices, robotics, automotive, commercial vehicles, EVs, rail, and more. As part of the global ALTEN Group—57,000+ engineers in 30 countries—we deliver across the entire product development cycle, from consulting to full project outsourcing. When you join ALTEN Technology USA, you’ll collaborate on some of the world's toughest engineering challenges, supported by mentorship, career growth opportunities, and comprehensive benefits. We take pride in fostering a culture where employees feel valued, supported, and inspired to grow. We are seeking a highly motivated and technically skilled professional with extensive experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical or biotech industry. Responsibilities: Review and refine basic and detailed designs to ensure compliance with quality and design standards. Plan, coordinate, and execute qualification and commissioning activities for new systems and equipment modifications. Develop, review, and execute qualification protocols (IQ/OQ/PQ) following GMP requirements. Identify and manage GMP and non‑GMP activities within project scopes. Oversee supplier services related to calibration and qualification, including FAT and SAT activities. Manage qualification and commissioning processes as the primary contact between Production, Engineering, and Quality departments. Execute commissioning and qualification of various systems and equipment such as:
API manufacturing units (reactors, crystallizers, dryers, centrifuges) Clean utilities (WFI, clean steam, process gases) Process equipment skids and automation systems (DeltaV, PCS7, etc.)
Coordinate with EPCM/EPC firms and cross‑functional teams including process, automation, construction, and validation disciplines. Evaluate chemical compatibilities for equipment and systems under specific process and cleaning conditions. Ensure alignment with CQV lifecycle stages (URS → FAT → SAT → IOQ → PQ). Qualifications: 5–10+ years of experience in pharma/biotech project execution (greenfield or brownfield). Proven track record of participation in large‑scale (>$50M USD) CAPEX projects from design through commissioning. Strong familiarity with GMP requirements and the CQV lifecycle. Hands‑on experience with API manufacturing systems, clean utilities, and process automation platforms. Experience collaborating with EPCM/EPC firms and multidisciplinary engineering teams. Proven experience in developing and executing qualification protocols, especially IQ/OQ. Excellent organizational, analytical, and communication skills. Bachelor’s or Master’s degree in Chemical, Mechanical, or Process Engineering. Nice to have:
Experience working with major global pharma clients. Familiarity with ISPE baseline guides, ASTM E2500, and GAMP5 methodologies.
Ability to work fully onsite in the Greater Trenton, NJ area. The actual salary offered is dependent on various factors including, but not limited to, location, the candidate's combination of job‑related knowledge, qualifications, skills, education, training, and experience. Equal Opportunity Employer
ALTEN Technology is an Equal Opportunity Employer. Compliance & Drug Screening
Alten USA maintains a drug‑free workplace. All candidates selected for employment will be required to successfully complete a pre‑employment drug screening as a condition of hire.
#J-18808-Ljbffr