What are the responsibilities and job description for the Technical Transfer Process Engineer position at Medical Engineering Consultants (MEC)?
Job 2483 Process Engineer- Contract to hire located near Saint Louis
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Role Summary
The candidate will support process validation activities and process transfer as a member of the Technical Transfer Process (TTP) Team supporting the contract manufacturing business unit. The candidate will primarily be responsible for supporting multiple technical transfer projects for the fill and finish of pharmaceutical and biological drug products. Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, authoring process validation protocols and reports, and supporting the development of manufacturing production records. Previous expertise with fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.
Role Responsibilities
Act as key technical lead for process development.
Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria.
Represents Tech Transfer department as subject matter expert routinely in meetings/conference calls with clients.
Works with client's lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals.
Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
Works independently and provide guidance to lower-level personnel or as a team member.
Execute QbD (Quality by Design) experiments to support the development and characterization of new manufacturing processes.
Independently manage multiple cross-functional projects that may require regulatory submissions.
Effectively present complex technical information to guide decision making.
Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
Perform periodic review of processes/systems.
Write and revise SOPs and Master Plans.
Apply CGMP and CGDP to all areas of work.
Support the development of manufacturing production records and protocols for execution in support of qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing.
Provide training to managers and production/laboratory staff for protocol requirements and new manufacturing processes.
Work with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.).
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Basic Qualifications
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.
Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.
MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).
MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.
Role Summary
The candidate will support process validation activities and process transfer as a member of the Technical Transfer Process (TTP) Team supporting the contract manufacturing business unit. The candidate will primarily be responsible for supporting multiple technical transfer projects for the fill and finish of pharmaceutical and biological drug products. Responsibilities include designing experiments/studies, authoring protocols (e.g., engineering runs; process performance qualifications), reviewing and analyzing complex data, authoring process validation protocols and reports, and supporting the development of manufacturing production records. Previous expertise with fill/finish operations, aseptic and/or isolator manufacturing, process validation/process performance qualifications, and technical writing are critical to this role. Candidate must also have excellent communication skills, both written and verbal.
Role Responsibilities
Act as key technical lead for process development.
Independently design and manage studies for process development, process optimization, scale-up, manufacturing records and technology transfer.
Independently design studies for evaluating the robustness of the manufacturing process. These studies will serve as a baseline for the further process validation activities.
Independently evaluate process data and perform in-depth analysis using scientific principles for evaluation of critical process parameters governing the performance of the process. Exercises judgement in selecting methods, techniques and evaluation criteria.
Represents Tech Transfer department as subject matter expert routinely in meetings/conference calls with clients.
Works with client's lead technical staff, department management and senior management to evaluate complex technical details pertaining to the project and defines the scope of the project.
Makes recommendations to the business development team regarding pricing and project studies and assist in preparation of project proposals.
Function as the Subject Matter Expert (SME) for Manufacturing processes and Technical Transfer of new products in regard to process development.
Collaborate with analytical, production, quality and project management team and ensure timely completion of project deliverables.
Independently review and analyze complex process data from the clinical and commercial manufacturing batches for conformity and facilitate batch release.
Works independently and provide guidance to lower-level personnel or as a team member.
Execute QbD (Quality by Design) experiments to support the development and characterization of new manufacturing processes.
Independently manage multiple cross-functional projects that may require regulatory submissions.
Effectively present complex technical information to guide decision making.
Independently author technical documents such as protocols, reports, deviations, gap analyses, risk assessments, etc.
Provide technical support for fill finish manufacturing activities including OOS/OOT investigation, process deviation impact, root cause investigation, process change and optimization.
Perform periodic review of processes/systems.
Write and revise SOPs and Master Plans.
Apply CGMP and CGDP to all areas of work.
Support the development of manufacturing production records and protocols for execution in support of qualifications, developmental/technical transfer projects, or for clinical and commercial manufacturing.
Provide training to managers and production/laboratory staff for protocol requirements and new manufacturing processes.
Work with individuals at all education/experience levels and with multiple departments (production, laboratory, engineering, materials management, etc.).
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.
Basic Qualifications
- B.S. in Science or Engineering with a minimum of 7 years of equivalent job experience.
- Strong leadership skills; high level of personal/departmental accountability and responsibility.
- Strong understanding of process design principles.
- Experience with drug product manufacturing processes development, process scale-up and optimization.
- Ability to perform well under tight timelines and excellent decision-making quality under pressure is desired.
- Ability to manage multiple priorities and tasks in a dynamic environment. Excellent written and communication skills
- Data evaluation and interpretation, including statistics and process controls. Experience and knowledge of sterile processing principles (aseptic or isolator technology).
- Ability to exercise judgment to determine appropriate corrective actions.
- Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
- Ability to work in a team environment with multiple departments and experience/educational levels.
- Proficient knowledge of CGMP.
- Coordinate multiple tasks simultaneously.
- Sponsorship is not available for this position
AAP/EEO DFWP
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Other Duties
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.