Manufacturing Validation Engineer III

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.).

Location

Location: Detroit, MI. Relocation assistance is NOT provided.

Qualifications

• Must be legally authorized to work in the United States without sponsorship.
• Must be able to pass a comprehensive background check, which includes a drug screening.

Skills

• Education: Bachelor degree (Preferred Fields of Study: Engineering, Life Sciences, or related technical field)
• Experience: 3+ years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry
• Knowledge, Skills, Abilities: Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems, Expertise in risk assessment methodologies and statistical analysis, Strong technical writing and documentation skills, Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements, Advanced problem-solving abilities and root cause analysis experience, Excellent verbal/written communication and interpersonal skills, Proficiency with relevant software tools (MS Office, statistical packages, validation systems), Flexibility to work extended hours or alternate shifts based on project needs, May require up to 25% travel

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits.

Pay

N/A

Schedule

N/A

Benefits

N/A