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Sr. Manufacturing Engineer
Job Description
Summary:
The main function of a manufacturing engineer is to apply engineering theory and principles to problems of industrial layout or manufacturing production. A typical manufacturing engineer has the ability to make engineering drawings and read and interpret blueprints. Project will be focused on validating (IQ, OQ, PQ) of equipment.
This role is critical to accelerating equipment validation timelines and requires a candidate who can contribute immediately with minimal onboarding.
Job Responsibilities:
• Expert knowledge of Installation, Operational and Performance Qualification (IQ, OQ, PQ) of complex systems and equipment
• Study time, motion, methods, and speed involved in maintenance, production, and other operations to establish standard production rate and improve efficiency.
• Interpret engineering drawings, schematic diagrams, or formulas and confer with management or engineering staff to determine quality and reliability standards.
• Read worker logs, product processing sheets, and specification sheets, to verify that records adhere to quality assurance specifications.
• Aid in planning work assignments in accordance with worker performance, machine capacity, production schedules, and anticipated delays.
• Prepare charts, graphs, and diagrams to illustrate workflow, routing, floor layouts, material handling, and machine utilization.
• Observe worker using equipment to verify that equipment is being operated and maintained according to quality assurance standards.
• Observe workers operating equipment or performing tasks to determine time involved and fatigue rate using timing devices.
• Evaluate data and write reports to validate or indicate deviations from existing standards.
Skills:
• Creativity, verbal and written communication skills, analytical and problem solving ability.
• Team player and detail oriented.
• Ability to make sketches, engineering drawings and common computations.
• Ability to read and interpret blueprints, technical drawing, schematics and computer-generated reports.
• Previous experience with computer applications and software related to engineering field, such as Computer Aided Design (CAD).
Must-Have Requirements:
• Hands-on experience with IQ, OQ, and PQ execution
• Experience in medical device validation
• Ability to clearly explain validation concepts (IQ/OQ/PQ)
• Ability to work independently with minimal ramp-up
Nice-to-Have:
• Prior experience with similar environments
• Experience as a repeat contractor in regulated environments
• Exposure to software validation within equipment systems
Soft Skills:
• Strong communication skills
• Ability to collaborate across teams
• Comfortable in fast-paced, high-priority environments
• Not siloed; team-oriented approach
Top Candidate Indicators:
• Can hit the ground running
• Requires minimal guidance
• Quickly understands project scope
• Demonstrates deep validation experience
Education/Experience:
• Bachelor's degree in engineering required.
• 5-7 years experience required.
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it’s from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
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