What are the responsibilities and job description for the Senior Process Engineer position at BioDuro-Sundia?
Job Title: Senior Process Engineer (Pharmaceutical Technology)
Department: Pharmaceutical Technology
Reporting To: Director, Pharmaceutics
Classification: Exempt
Salary Range: 96k-118k
What We Do
BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.
Why BioDuro-Sundia?
Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
The Senior Process Engineer, under minimal general direction, independently performs various duties related to optimization and analysis of production processes, new products and processes, and technology transfers. Provides support for troubleshooting and improvements to existing products and processes. This individual contributor supports routine commercial manufacturing, lead late-stage and commercial technology transfers, support process scale-ups, and complete process validation activities.
Essential Functions and Responsibilities
Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.
Perform on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
Conduct formulation development and evaluation for marketed and new products.
Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
Conduct investigations on deviations.
Evaluate and troubleshoot mid to high level manufacturing / packaging equipment and process issues.
Work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors. Recommend solutions to technical issues.
Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
Frequently interact with team members, supervisors, outside customers/vendors, & other teams/departments. Interaction normally requires the ability to gain cooperation of other departments, conducting presentations of technical information concerning specific projects/schedules, etc.
This job description is subject to change at any time.
Requirements
BS degree in Engineering or Chemical Engineering preferred with 8 years’ related experience OR
MS with 5 years’ experience as noted above OR
PhD with 2-3 years of experience as noted above.
Experience with process validation and commercial manufacturing
Direct hands-on experience within a manufacturing environment
Experience with scale-up and scale-down models
Knowledgeable of QbD, Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
Complete understanding of Pharmaceuticals manufacturing principles, practices and applications.
Working knowledge of Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
Understanding of concepts of equipment qualification/calibration.
Understanding of computer validation concepts.
Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
Has general working knowledge of principles and concepts of other disciplines within own function.
Is recognized by colleagues as a technical expert and provides technical advice and counsel on complex problems in areas of expertise.
Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.
The noise level in the work environment is usually moderate.
Preferred Qualifications
Self-directed: an individual who is able to work effectively with limited direction in a complex, fast-paced environment
Prior experience with Oral Solid Dosages, specifically in the areas of blending, Tableting and capsule filling
Prior expereince in the development of pharmaceutical processes, technology transfers, and scale-up of spray-drying, particle reduction, blending, tablet compression, capsule filling, fluid bed/pan coating of multi-particulates and tablets respectively.
Is able to write clearly and succinctly for the technical community and can construct logical arguments well.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Benefits
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing (url removed). If you are selected to interview for a position, you may also request an accommodation with our team directly.
Notice to Agency and Search Firm Representatives
BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Department: Pharmaceutical Technology
Reporting To: Director, Pharmaceutics
Classification: Exempt
Salary Range: 96k-118k
What We Do
BioDuro-Sundia is one of the premier Contract Research, Development and Manufacturing Organizations (CRDMO) globally, with more than 2,200 employees. Our US operations are US headquartered in Irvine, CA. Our 10 global facilities provide integrated solutions and exceptional services to our clientele for challenging preclinical and clinical trial projects. With capabilities spanning Drug Discovery, Development, and Manufacturing, it is no surprise that BioDuro-Sundia is a leading partner of choice.
Why BioDuro-Sundia?
Take the next step in your career and join BioDuro-Sundia today to change lives through the products we help create. Here, you will contribute your talents to meaningful projects that impact the lives of patients around the world and develop as an individual by working directly with a team of seasoned experts and rising stars. Our values of Accountability, Respect, Tenacity, Results and Integrity are embedded in everything we do. No matter what your role may be, BioDuro-Sundia strives to ensure all our employees are empowered and given the necessary tools to lead us in our relentless pursuit of success.
Job Overview/Summary
The Senior Process Engineer, under minimal general direction, independently performs various duties related to optimization and analysis of production processes, new products and processes, and technology transfers. Provides support for troubleshooting and improvements to existing products and processes. This individual contributor supports routine commercial manufacturing, lead late-stage and commercial technology transfers, support process scale-ups, and complete process validation activities.
Essential Functions and Responsibilities
Prepare and execute engineering study protocols, manufacturing and packaging experimental / feasibility study / validation batch records and protocols and complete interim and / or final summary reports for marketed and new products.
Coordinate with Facilities, Engineering, Manufacturing, Packaging, Product Development, Analytical Services, RA, and QA to initiate manufacturing and packaging experimental / feasibility study / validation projects for marketed and new products.
Perform on-site and site-change technical transfer, scale-up or scale-down factor evaluation, manufacturing / packaging process and equipment troubleshooting, and SOP preparation and review.
Conduct formulation development and evaluation for marketed and new products.
Troubleshoot the setup and operation of manufacturing/packaging equipment and the process of new R&D projects.
Conduct investigations on deviations.
Evaluate and troubleshoot mid to high level manufacturing / packaging equipment and process issues.
Work on problems of increasing complexity where analysis of situation or data requires review of identifiable factors. Recommend solutions to technical issues.
Conduct training to related department personnel on all technical and project-related documents, such as batch records, protocols, and SOP etc.
Frequently interact with team members, supervisors, outside customers/vendors, & other teams/departments. Interaction normally requires the ability to gain cooperation of other departments, conducting presentations of technical information concerning specific projects/schedules, etc.
This job description is subject to change at any time.
Requirements
BS degree in Engineering or Chemical Engineering preferred with 8 years’ related experience OR
MS with 5 years’ experience as noted above OR
PhD with 2-3 years of experience as noted above.
Experience with process validation and commercial manufacturing
Direct hands-on experience within a manufacturing environment
Experience with scale-up and scale-down models
Knowledgeable of QbD, Current Good Manufacturing Practices (cGMP), FDA, OSHA, EPA, DEA; other regulatory requirements.
Complete understanding of Pharmaceuticals manufacturing principles, practices and applications.
Working knowledge of Analytical test methodology (BU, Assay, CU and dissolution profile, etc.).
Understanding of concepts of equipment qualification/calibration.
Understanding of computer validation concepts.
Intermediate statistical computations (Cp, Cpk, regression analysis, etc.); use of statistical software.
Personal computer operations and MS applications (Word, Access, Excel, PowerPoint, MS Project).
Has general working knowledge of principles and concepts of other disciplines within own function.
Is recognized by colleagues as a technical expert and provides technical advice and counsel on complex problems in areas of expertise.
Employee is occasionally required to climb or balance; must occasionally lift and/or move up to 50 pounds.
Employee is frequently exposed to moving mechanical parts, and occasionally exposed to outside weather conditions and risk of electrical shock.
The noise level in the work environment is usually moderate.
Preferred Qualifications
Self-directed: an individual who is able to work effectively with limited direction in a complex, fast-paced environment
Prior experience with Oral Solid Dosages, specifically in the areas of blending, Tableting and capsule filling
Prior expereince in the development of pharmaceutical processes, technology transfers, and scale-up of spray-drying, particle reduction, blending, tablet compression, capsule filling, fluid bed/pan coating of multi-particulates and tablets respectively.
Is able to write clearly and succinctly for the technical community and can construct logical arguments well.
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs; Presents numerical data effectively; Able to read and interpret written information.
Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.
Organizational Support - Follows policies and procedures; Completes administrative tasks correctly and on time; supports organization's goals and values; Benefits organization through outside activities; Supports affirmative action and respects diversity.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.
Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention.
Benefits
We offer full health benefits, paid vacation and sick leave, an aggressive bonus structure, and market-competitive salaries to all our employees. In addition, BioDuro-Sundia provides employees with a variety of engaging employee and community outreach events. We strive to reward and promote employees who exhibit our values of Accountability, Respect, Tenacity, Results and Integrity.
EOE and Accommodation
We value diversity and are proud to be an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law. BioDuro-Sundia provides reasonable accommodation in job application procedures for qualified individuals with disabilities and disabled veterans. If you need accommodation in connection with the recruiting process due to a disability, you may use the alternative methods by emailing (url removed). If you are selected to interview for a position, you may also request an accommodation with our team directly.
Notice to Agency and Search Firm Representatives
BioDuro-Sundia is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any BioDuro-Sundia employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of BioDuro-Sundia. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
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