Manufacturing Process Engineer

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Join our team as a Manufacturing Sciences Scientist II, where you'll contribute to ensuring consistent production of therapeutic and diagnostic products. As part of our Manufacturing Sciences team, you'll work at the intersection of research and production, supporting process optimization, technology transfer, and continuous improvement initiatives. You'll collaborate with cross-functional teams to resolve technical challenges and ensure robust, scalable manufacturing processes that meet quality standards.

As a Manufacturing Scientist II, you will lead and/or implement activities for the development of new and established manufacturing processes of solids, liquids, and semi-solid dosage forms. Project management skills will be applied to implement the scaling up manufacturing processes, supporting new product validations and post approval qualifications activities. This will require the writing, approval, and routing documents within a manufacturing setting.

You will be the primary technical representative on client projects and will work closely work with internal and external project teams of analytical, quality, and project management representatives. Supporting process development and commercial activities will be required. Leads technical/scientific project activities and discussions to lead strategies and technical solutions that meet client needs and expectations.

Investigates, creates, and validates new scientific and equipment methodologies for a diverse scope of projects. Using experimental design, established formulation processes for the following phases of product scale-up, registration, and validation.

Creates processes and equipment design for clinical, scale up, and/or registration batches, including technology transfer of projects to and from clients. Leads problem solving activities as necessary with independent judgement. Makes decisions that require choosing between multiple options or may develop new options to resolve moderately complex problems.

REQUIREMENTS:

• Advanced Degree with no prior experience required, OR Bachelor's Degree plus 2 years of experience in GMP manufacturing, process development, or related technical role
• Preferred Fields of Study: Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.
• Strong understanding of cGMP requirements, regulatory compliance, and quality systems
• Experience with process validation, technology transfer, and scale-up activities
• Strong project management and documentation skills
• Excellent written and verbal communication abilities
• Ability to work independently and collaboratively in a dynamic environment
• Demonstrated problem-solving and troubleshooting capabilities
• Proficient with Microsoft Office Suite and relevant manufacturing/quality systems
• Experience with risk assessment and root cause analysis
• Ability to train and support team members
• May require occasional weekend/off-hours support
• Must be able to wear required PPE and work in controlled environments
• Physical requirements include ability to lift up to 35 lbs and stand for extended periods
• Additional language skills beneficial

How will you get here?

Education

Bachelor's degree in chemical engineering (or other engineering field), chemistry, pharmacy, or other related science or technical field is required.

Experience

• Minimum of one (1) to three (3) years of experience in a manufacturing environment. Experience in product or process development, including scale-up and technology transfer processes for both immediate and controlled release dosage forms preferred.
• Project Management experience with a minimum (1) year of experience.

Knowledge, Skills, Abilities

• Understanding of Good Manufacturing Practices (GMP) and regulatory compliance.
• Lead projects of moderate to high complexity in scope and compliance-related challenges to implementing processes to meet changing regulations.
• Proficiency using Microsoft (MS) Office applications.
• Good critical and logical thinking skills. Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
• Self-starter, mature, independent, and detailed oriented.
• Ability to work in a fast-paced, results oriented, and structured environment.
• Experience leading projects related to process development including scale-up production activities.
• Effective time management, multi-tasking and prioritization skills to effectively run multiple projects.
• Lead by example.
• Courages and assumes challenges in a risk based approaches.
• Transparent and knowledgeable in presenting project updates daily.
• Diligent in team meetings and discussions.
• Collaborate across multiple departments to reach goals and objectives.
• Inclusive with communication styles and ideas.
• Conscientious to fellow peers with work load requirements.
• Coordinate and lead weekly meetings with customers.
• Fast and focused execution of tasks will be required at time.
• Build helpful ideas to increase production efficiencies.
• Technical skill information transferred to supporting departments.
• Participate and support audit participation and interaction for regulatory agencies.
• Develop and transform learning to peers with technical and mechanical result oriented aptitudes.
• Written communication skills expected and presentation will be expected.

Physical Requirements:

Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically, manipulation (lift, carry, move) of light to medium weights of 10-35 pounds; arm, hand and finger dexterity, including ability to grasp and type for periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.